Clinical trial NCT04216784
Conditions: Cirrhosis, Liver Volume Overload Fluid Overload
Sponsor: Rush University Medical Center
Start date: 2019-12-19; Completion date: 2024-04-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A common complication of the progression of cirrhosis is fluid retention (ascites, edema, or pleural effusion). Loop diuretics are the treatment of choice for fluid retention in cirrhotic patients; however, many of these patients demonstrate diuretic resistance, requiring higher doses of the diuretics to achieve adequate diuresis. The cause of this diuretic resistance is hypothesized to be secondary to hypoalbuminemia which has led some providers to give human albumin in combination with loop diuretics to increase intravascular volume and facilitate diuresis. However, this practice remains controversial because minimal data exists to support its efficacy. The purpose of this study is to compare the efficacy of diuretics alone versus diuretics in combination with albumin in cirrhotic patients presenting with fluid retention.

Detailed description:
The purpose of this single center, prospective study is to compare the efficacy of two strategies for diuresis in patients with cirrhosis, the use of furosemide (Lasix®) alone versus the combination of furosemide (Lasix ®) and albumin (25%). The investigators will perform a single-center, prospective study with data collected as result of standard of care at Rush University Medical Center (RUMC). Patients who are 18 years of age and older, have diagnosed cirrhosis, and present to RUMC with fluid retention will be identified by the Hepatology and/or Surgery attending and be screened for inclusion in the study. Each patient will be randomized into one of the two cohorts and will have 50% chance of being placed into either cohort. Cohort 1 will receive furosemide (Lasix) 40 to 80 mg intravenous push (IVP) twice a day (BID) for at least 48 hours and cohort 2 will receive combination of furosemide (Lasix) 40 to 80 mg IVP BID and albumin (25%) 12.5 grams BID for at least 48 hours.

Arms: arm 1: Cohort 1 will receive furosemide (Lasix) 40 to 80 mg IVP BID for at least 48 hours arm 2: Cohort 2 will receive combination of furosemide (Lasix) 40 to 80 mg IVP BID and albumin (25%) 12.5 grams IV BID for at least 48 hours
Interventions: intervention 1: Furosemide Injection intervention 2: Albumin Human
Intervention descriptions: intervention 1: Patient will receive furosemide intravenously intervention 2: Patient will receive albumin (25%) 12.5 gm intravenously

Protocol documents:
Prot_SAP_000.pdf: 
Cover Page: Study Protocol 
 
Protocol Title: Comparison of furosemide alone versus the combination of furosemide and 
albumin for diuresis in cirrhotic patients with ﬂuid retention 
 
NCT: 04216784 
 
Document Date: 12/5/2019 


I.
Abstract:
a.
A common complication of the progression of cirrhosis is fluid retention (ascites, edema, 
or pleural effusion). Loop diuretics are the treatment of choice for fluid retention in 
cirrhotic patients; however, many of these patients demonstrate diuretic resistance, 
requiring higher doses of the diuretics to achieve adequate diuresis. The cause of this 
diuretic resistance is hypothesized to be secondary to hypoalbuminemia which has led 
some providers to give human albumin in combination with loop diuretics to increase 
intravascular volume and facilitate diuresis. However, this practice remains 
controversial because minimal data exists to support its efficacy.  The purpose of this 
study is to compare the efficacy of diuretics alone versus diuretics in combination with 
albumin in cirrhotic patients presenting with fluid retention.
II.
Background and Significance: 
a.
Accumulation of fluid as ascites, edema, or pleural effusion is common in patients with 
advanced liver disease.1 Typically, treatment of fluid retention is extrapolated from the 
practice guidelines by the American Association for the Study of Liver Diseases (AASLD) 
for the management of adult patients with ascites due to cirrhosis.2 According to these 
guidelines, first line treatments for management of ascites are cessation of alcohol use 
(when applicable), restricting sodium and fluid intake, and using diuretics (such as loop 
diuretics). However, many patients with cirrhosis demonstrate diuretic resistance and 
require higher doses of these medications to obtain the desired clinical effect. Since 
hypoalbuminemia is postulated to be one of the causes of diuretic resistance in cirrhotic 
patients, some providers recommend giving albumin in combination with loop diuretics 
for the treatment of fluid retention. This recommendation developed from the current 
understanding of the pathophysiology of liver disease and its effect on intravascular 
space leading to fluid retention.1 Despite this common trend in practice, there remains 
minimal data that compares the efficacy of diuresis using diuretics alone versus the 
combination of diuretics and albumin.
Currently, there is only one randomized, controlled trial published in 1999 that 
compared the use of diuretics alone versus the combination of diuretics and albumin in 
cirrhotic patients.3 This was a single center conducted in Italy where the investigators 
used potassium canrenoate and furosemide as diuretics in combination with albumin 
(25%) 12.5 grams daily. The doses of diuretics used were per center protocol and based 
on patient clinical response. The results from their study showed that the cumulative 
rate of response to diuretic treatment of ascites was higher (90.5% vs. 74.7%) (p< 0.05) 
and length of hospital stay was shorter (p< 0.05) in the group of patients that received 
diuretics and albumin versus diuretics alone.  Although the results were favorable with 
the use of albumin, the external validity of this study is minimal since it was a single 
center conducted in Italy in 1999.
III.
Study Aims
ORA: 19092507-IRB01   Date IRB Approved: 12/5/2019


a.
The purpose of this single center, prospective study is to compare the efficacy of two 
strategies for diuresis in patients with cirrhosis, the use of furosemide (Lasix®) alone 
versus the combination of furosemide (Lasix ®) and albumin (25%). 
IV.
Administrative Organization
a.
All research regarding this project will be performed at Rush University Medical Center 
(RUMC). There will be no inclusion of outside study sites, laboratories, or data 
management centers.
V.
Methods and Materials
a.
Trial Design and sample size
i.
We will perform a single-center, prospective study with data collected as result 
of standard of care at RUMC. Patients who are 18 years of age and older, have 
diagnosed cirrhosis, and present to RUMC with fluid retention will be identified 
by the Hepatology and/or Surgery attending and be screened for inclusion in the 
study. Each patient will be randomized into one of the two cohorts and will have 
50% chance of being placed into either cohort. 
 Cohort 1 will receive furosemide (Lasix) 40 to 80 mg IVP BID for at least 48 
hours and cohort 2 will receive combination of furosemide (Lasix) 40 to 80 mg 
IVP BID and albumin (25%) 12.5 grams BID for at least 48 hours.
ii.
A sample size of 150 patients for this study was estimated based on the 
previously published study by Gentilini P and colleagues.3 The estimation was 
based on a success rate of 70% in patients receiving diuretics alone and 90% in 
patients receiving diuretics plus albumin (alpha = 0.05; beta =0.25). 
b.
Process of Consent
i.
This study is a prospective study so consent from the patient will be obtained 
prior to enrollment. To obtain consent, the physician will explain the purpose of 
the study, associated risk and benefits, and answer any additional questions or 
concerns the patient may ask. If patient decides to enroll in the study, the 
physician will provide them with the appropriate consent form and all signed 
forms will be in a securely locked filing cabinet.
c.
Participants
i.
Adult patients (age >18 years old) who have cirrhosis and present to RUMC with 
fluid retention (ascites, edema, or pulmonary effusions). 
d.
Inclusion/Exclusion Criteria
i.
Inclusion criteria: Adult patients (age >18 years old), diagnosis of cirrhosis and 
presents with fluid retention as defined as ascites, edema, or pulmonary 
effusions requiring diuresis.
ORA: 19092507-IRB01   Date IRB Approved: 12/5/2019


ii.
Exclusion criteria: Patients who are younger than 18 years of age or currently 
pregnant or who presents with a serum creatinine greater than 2 mg/dL will be 
excluded.
e.
Outcomes
i.
Primary outcome: Urine output greater than or equal to 0.5 ml/kg/hour over 24 
hours or reduction in weight defined as weight loss of 1 kilogram or greater in a 
24-hour period. (While urine output is the best measure for diuretic efficacy, it 
can often be an unreliable measurement due to patient’s not collecting urine 
properly. Therefore, changes in weight after initiation of diuretic therapy is often 
used as a surrogate marker for the efficacy of the diuretic therapy, regardless of 
patient weight at baseline. Several heart failure trials use a change in weight as 
the endpoint for assessing diuretic efficacy, and this endpoint is also commonly 
used in clinical practice. Therefore, that is why this endpoint was chosen for this 
study.)
ii.
Secondary outcome: Change in renal function as defined by a chance in serum 
creatinine from admission to discharge, hospital length of stay, 30-day 
readmission rates, and patient survival at 6 months and 1 year. 
VI.
Risk/Benefit Assessment
a.
Potential Risks
This study is a prospective trial however minimal risk to the patient is associated with 
participation in this study as he/she will be receiving one of two standard of care 
treatments at our center. Minimal risks associated with the study include experiencing 
common side effects from the FDA-approved medications used for treatment. The most 
common side effects of furosemide administered intravenously are low blood pressure, 
dizziness, headache, or irritation of the skin at the site of injection. In addition, the most 
common side effects of albumin administered intravenously are high blood pressure, 
headache, nausea/vomiting or irritation of the skin at the site of injection. There is also 
a potential risk for invasion of privacy since medical records will be accessed but all data 
will be de-identified to limit the chance of exposure of PHI.
b.
Protection against risks
Physicians will be assessing patients in the study daily and will take precautions against 
the potential common side effects associated with the FDA-approved medications in 
this study as stated previously. Precautions include daily monitoring of patients through 
labs and physical examination and making medical interventions as deemed 
appropriate.
Data will be collected from the electronic medical record which will be de-identified and 
maintained in Research Electronic Data Capture (RedCap).
c.
Potential benefits to subjects
Patients may benefit from taking part in this study. Based on experience with the use of 
furosemide (Lasix) and albumin in patients with similar conditions, researchers believe it 
ORA: 19092507-IRB01   Date IRB Approved: 12/5/2019


may be of benefit to people with cirrhosis. However, because individuals respond 
differently to therapy, no one can know in advance if it will be helpful for these patients. 
If the current therapy is not deemed helpful by the physician, the physician will start an 
alternative standard of care treatment for the patient. 
d.
Alternatives to participation
Patients may choose to not participate in this study. If participants choose to not 
participate in this study, the physicians will determine an alternative treatment plan for 
their fluid retention.
VII.
Confidentiality of data and information storage
a.
Data collection will take place on a data collection tool, which will be separate from PHI 
and will not contain identifiers.  RedCAP will be used for data collection and storage. 
Patient confidentiality will be maintained by recording only de-identified data onto the 
data collection form.  Although the data collected and stored in REDCap will be exported 
for analysis, the exported data will contain no unique, patient-identifying information. 
Access will only be available to the research investigators.
Data collected from the electronic medical record at RUMC will include:
1.
Patient demographics
2.
Daily lab results including chemistry panel, INR, liver function tests, 
renal function tests
3.
Physician’s rating of patient’s edema (if applicable)
4.
Dose, frequency, and administration of furosemide (Lasix ®) and/or 
albumin 
VIII.
Analysis Plan
a.
Statistical analysis will be performed with SPSS statistical package. Patient 
characteristics will be described using frequencies, means + standard deviations or 
medians ± interquartile ranges. Student’s t-test will be used to compare continuous 
variables. Comparisons between groups or categories will be made using chi-squared 
test. The threshold for statistical significance will be p<0.05. 
IX.
Literature Cited 
1.
Kashani A, Landaverde C, Medici V, and Rossaro L. Fluid retention in 
cirrhosis: pathophysiology and management. Q J Med 2008; 101:71-85. 
2.
American Association for the Study of Liver Diseases (AASLD): Practice 
guidelines for the management of adult patients with ascites due to 
cirrhosis 2012. Hepatology 57(4), 2013.
3.
Gentilini P, Casini-Raggi V, Di Fiore G, et al. Albumin improves the 
response to diuretics in patients with cirrhosis and ascites: results of a 
randomized, controlled trial. J Hepatol. 1999 Apr;30(4):639-45.
ORA: 19092507-IRB01   Date IRB Approved: 12/5/2019


ORA: 19092507-IRB01   Date IRB Approved: 12/5/2019

ICF_001.pdf: 
Cover Page: Informed Consent 
 
Protocol Title: Comparison of furosemide alone versus the combination of furosemide and 
albumin for diuresis in cirrhotic patients with ﬂuid retention 
 
NCT: 04216784 
 
Document Date: 07/01/2020 


 
Rush Template Version Date: 07/01/2019 
Consent Version Date: 07/01/2020 
 
Page 1 of 7 
 
 
 
CONSENT/AUTHORIZATION FOR PARTICIPATION IN A RESEARCH 
STUDY 
 
Site Principal Investigator: 
Nicole Alvey, PharmD 
Department: 
Pharmacy 
Address and Contact Information: 1653 West Congress Parkway, Chicago, IL 60612 
E-mail: Nicole_Alvey@rush.edu 
 
Protocol Title: 
Comparison of furosemide alone versus the combination of 
furosemide and albumin for diuresis in cirrhotic patients 
with fluid retention 
 
 
Name of Participant:  __________________________________________________________ 
 
Key Information: 
 
You are being invited to participate in a research study. Research studies answer important 
questions that might help change or improve the way we do things in the future. 
 
This consent form will give you information about the study to help you decide whether you 
want to participate. Please read this form, and ask any questions you have, before agreeing to be 
in the study. 
 
Taking part in this research study is voluntary. You do not have to participate in this study and 
may choose to leave the study at any time. If you decide not to participate in this study or leave 
the study at a later time, your health care, benefits, or relationship with Rush University Medical 
Center will not change or be affected. 
 
The purpose of this study is to assess the difference between two methods of increasing fluid 
removal in patients with liver disease. The study will involve the use of furosemide (Lasix ®) 
and albumin. Furosemide is approved for use by the United States Food and Drug 
Administration (FDA) for edema (fluid retention) and cirrhotic ascites (fluid retention in the 
abdomen). Albumin is approved for use by the United States FDA but does not carry the 
indication for edema and cirrhotic ascites.   
 
If you agree to participate in this study, your participation may last up to 7 days during your 
hospital stay. There will be no additional study visits once you have been discharged from the 
hospital.  
 
There are risks to you for participating in this study. In this study, there is a risk of decreased 
kidney function and potentially experiencing side effects of the medications used in the study. 


 
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The most common side effects of furosemide include low blood pressure, dizziness and/or 
headache and irritation of the skin at the site of injection. The most common side effects of 
albumin are high blood pressure, headache, nausea/vomiting, and irritation of the skin at the site 
of injection. However, your physician will be monitoring you daily during the study and will 
take precautions to prevent these from happening. In addition, there is a risk of loss of 
confidentiality if your medical information or your identity is obtained by someone other than 
the investigators, but precautions will be taken to prevent this from happening. 
 
There may be no benefit to you from taking part in this study, which is why we are doing this 
research to compare the different options available. Our hope is that it will possibly help you or 
benefit other people in the future. Because individuals respond differently to therapy, no one can 
know in advance if it will be helpful for you. If the therapy that is chosen for you is not believed 
to be helpful for you by your doctor, the doctor will start an alternative standard of care 
treatment.   
 
You also have the option to not participate in this study. If you choose not to participate in this 
study, the physician will determine your treatment plan, which typically includes the drugs 
furosemide (Lasix ®) and albumin. You should discuss this with your study doctor. 
 
Detailed Information: Please review the rest of this document for details about 
the above topics and additional information you should know before making a 
decision about whether or not you will participate in this study. 
 
Why are you being invited to participate in this study? 
You are being asked to participate in this study because you have liver disease that is causing an 
buildup of fluid. In order to treat this condition, your provider will give you medications to help 
you urinate and remove some of the fluid.  
 
How many participants will take part in this study? 
Approximately 150 participants at Rush University Medical Center are expected to take part in 
this study.  
 
 
 


 
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What are the activities you will be doing if you participate in this study? 
 
If you agree to participate in this study, you must first sign this informed consent form. 
Afterwards, you will be able to take part in the study activities. The study activities will either 
begin the day you sign the consent form or the day after.  
 
Before you begin the study: 
 You will be randomized to 1 of 2 groups and you will have a 50% chance of being in 
each group. Randomization means that you will be assigned by chance (like flipping a 
coin) to see which group (heads/tails) you will be put into. 
o Group 1 will receive the standard of care with furosemide (Lasix ®) intravenously 
(into the vein) between 40 to 80 mg twice a day for at least 2 days. 
o Group 2 will receive the standard of care with furosemide (Lasix ®) intravenously 
between 40 to 80 mg twice a day with albumin 12.5 grams intravenously twice a 
day for at least 2 days. 
 On the first day of your study participation, you will be administered the medications 
mentioned above based on your group assignment.  
 
During the study:  
 Once you have been randomized, your healthcare provider will monitor your daily 
response to the medications you received and obtain daily blood draws from your vein for 
labs. You will also be asked to urinate in a urine collection cylinder to measure how 
much urine you are making and your weight will be recorded daily by the nurse. The 
monitoring by your healthcare provider is standard of care. 
 Depending on your response to the medications on day 3 of your study participation, your 
healthcare provider may change your treatment plan.  
 If you are not improving on the medications and you have been randomized into Group 1, 
your healthcare provider may switch your medications to the alternative standard of care 
treatment that is assigned to Group 2. 
 If you are not improving on the medications and you have been randomized into Group 2, 
your healthcare provider may switch your medications to the alternative standard of care 
treatment that is assigned to Group 1. 
 
After you have completed treatment  
 Your healthcare provider will continue to monitor your labs through daily blood draws 
from your vein. This is standard of care regardless of which treatment group you are 
randomized into.  
 
What are the risks and discomforts of participating in this study? 
 
Side effects, risks, and/or discomforts from participation in this study may include: 
 The most common side effects of furosemide: 
o Low blood pressure 
o Dizziness 
o Headache 
o Irritation of the skin at the site of injection 


 
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 The most common side effects of albumin:  
o High blood pressure 
o Headache 
o Nausea/vomiting 
o Irritation of the skin at the site of injection 
 
There may be other risks that may happen that we cannot predict. The study doctor or staff can 
discuss any questions you have about these medications. 
 
Can you leave or be removed from this study? 
You have the right to leave a study at any time without penalty. For your safety, however, you 
should consider the study doctor’s advice about how to leave this study. If you choose to 
withdraw from the study, you will be able to withdraw the same day you make your decision and 
there will be no consequences associated with your decision. Your study doctor will adjust your 
treatment plan according to where you are in your treatment course when you exit the study.    
 
The researchers and sponsor also have the right to stop your participation in this study without 
your consent if: 
 They believe it is in your best interests; 
 You do not follow the instructions of study staff; 
 The study is cancelled for any reason. 
 
What about confidentiality of your medical information? 
This authorization is voluntary. Rush University Medical Center and its affiliates (“Rush”) will 
not withhold or refuse your treatment, payment, enrollment, or eligibility for benefits if you sign 
this authorization. You do not have to sign this authorization, but that means that you cannot be 
in the study or receive study-related treatment. 
 
By signing this document, you voluntarily authorize (give permission to) Dr. Nicole Alvey, 
PharmD and her study team, and other Rush personnel involved with the conduct and review of 
this study to use or disclose (release) health information that identifies you for the study 
described in this document. 
 
 
During the study, Dr. Nicole Alvey, PharmD and her study team will collect Protected Health 
Information (PHI) about you for the purposes of this research. PHI is your health information 
that includes your medical history and new information obtained as a result of this study. Some 
of this information will come from your medical record. The health information that Rush may 
used or disclosed for this research includes: 
 Weight 
 Results of lab tests 
 Urine output 
 
Dr. Nicole Alvey, PharmD and her study team may share your health information and the results 
of your study-related procedures and tests with people outside of Rush who assist with the 
conduct and review of this study. The persons who receive your health information may not be 


 
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required by Federal privacy laws to protect it and may share your information with others 
without your permission, but only if permitted by the laws governing them. Your health 
information described above may be used or disclosed to: 
 To the Researchers: Rush University Medical Center (RUMC) Transplant Surgery 
Attendings, RUMC Hepatology Attendings and Transplant Pharmacists  
 Monitoring agencies such as the Food and Drug Administration (FDA), the National 
Institutes of Health and the Rush Institutional Review Board (IRB). 
 
While you participate in the study you will have access to your medical record, but Dr. Nicole 
Alvey, PharmD is not required to release your study information that is not part of your medical 
record. Rush is required by law to protect your health information, and study records that 
identify you will be kept confidential. The results of study tests/procedures performed as part of 
this study may become part of your medical record. Any study information in your medical 
record will be kept indefinitely. Your identity will not be revealed on any report, publication, or 
at scientific meetings.  
 
You have a right to inspect and copy the information to be disclosed with this authorization and 
you may obtain a copy of the information by contacting the office listed above. 
 
If you no longer want to be in the study and do not want your future health information to be 
used, you may change your mind and revoke (take back) this authorization at any time by writing 
to Dr. Alvey at 1653 West Congress Parkway, Chicago, IL 60612.If the authorization is revoked, 
you will no longer be allowed to participate in the study and previously authorized 
individuals/entities may still use or disclose health information that they have already obtained 
about you as necessary to maintain the integrity or reliability of the current study. 
 
This authorization is valid for the entirety of this research study. It will expire upon completion 
of the study or if you revoke (take back) the authorization. 
 
If you withdraw from this study, the data already collected from you may not be removed from 
the study records. The study doctor and/or study team may ask you whether they can continue to 
collect follow-up data on you. If follow-up information will be requested, you will be asked to 
sign a separate consent form before this information can be collected. 
 
Records of participation in this study will be maintained and kept confidential as required by 
law. All identifying information will be de-identified. Data collected from your medical record 
will be recorded in a secure, password protected database. 
 
The Rush Institutional Review Board (IRB) will have access to your files as they pertain to this 
research study. The IRB is a special committee that reviews new and ongoing human research 
studies to check that the rules and regulations are followed regarding the protection of the rights 
and welfare of human participants. 
 
What are the costs to participate in this study? 
You or your insurance will be responsible for paying the cost of the hospital visit. Participation 
in this study puts you in one of two standard of care treatment groups which is included in your 


 
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hospital bill at discharge. If you have health insurance the insurance may or may not pay for the 
costs associated with your participation in this study. You will have to pay for any co-payments, 
deductibles or co-insurance amounts that your insurance coverage requires. 
 
Will you be paid for your participation in this study? 
 
You will not be paid for being in this study. 
 
What if you are injured as a result of your participation in this study?  
 
If you get ill or injured from being in the study, Rush University Medical Center will help you 
get medical treatment. You should let the study doctor know right away that you are ill or 
injured. If you believe you have become ill or injured from this study, you should contact, 
attending physician Dr. Chan, who is a transplant surgery attending assisting with enrollment in 
this study, at 312-942-4252. 
 
You should let any health care provider who treats you know that you are in this study. If you do 
seek medical treatment, please take a copy of this document with you because it may help the 
doctors where you seek treatment to treat you. It will also provide the doctors where you seek 
treatment with information they may need if they want to contact your study doctor. 
 
You or your health insurance plan will be billed. No money has been set aside to pay the costs of 
this treatment. Health insurance plans may or may not cover costs of research-related injury or 
illness. You should check with your insurance company before deciding to participate in this 
research study. Costs not covered by insurance could be substantial. 
 
Rush University Medical Center has no program for financial compensation or other forms of 
compensation for injuries which you may incur as a result of participation in this study. 
 
By signing this form, you are not giving up any legal rights to seek compensation of injury. 
 
What other information should you know about? 
Investigator Dual-Role 
Your health care provider is an investigator on this research study, and as an investigator, is 
interested in both your clinical welfare and in the conduct of this study. Before entering this 
study or at any time during the research, you may ask for a second opinion about your care from 
a clinician who is not associated with this study. You are not obligated to participate in any 
research study offered by your clinician. The decision to not participate will not affect your 
clinical care now or in the future. 
 
Who can you contact for more information about this study? 
Questions are encouraged. If you have further questions about this study, you may e-mail Dr. 
Nicole Alvey, PharmD at her e-mail address: Nicole_Alvey@ rush.edu 
 
Who can you contact if you have concerns about your rights as a study participant? 
Questions about the rights of research participants may be addressed to the Rush University 


 
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Medical Center Office of Research Affairs at 1-800-876-0772. 
 
What are your rights as a study participant? 
Taking part in this study is voluntary. If you choose not to participate in this study or to leave the 
study at any time, your health care, benefits or relationship at Rush University Medical Center 
will not change or be affected. 
 
If you choose to leave this study and you do not want any of your information to be used, you 
must inform Dr. Alvey in writing at the address on the first page. Dr. Alvey may still use your 
information that was collected prior to your written notice. 
 
 
SIGNATURE BY THE PARTICIPANT: 
By signing below, you are consenting to participate in this research study. You have read the 
information given or someone has read it to you. You have had the opportunity to ask questions, 
which have been answered satisfactorily to you by the study staff. You do not waive any of your 
legal rights by signing this consent form. You will be given a signed copy of this consent. 
 
_________________________________ 
_______________________ __________________ 
Name of Participant  
 
 
Signature of Participant 
Date of Signature 
 
 
SIGNATURE BY THE INDIVIDUAL OBTAINING CONSENT: 
I attest that all the elements of informed consent described in this consent document have been 
discussed fully in non-technical terms with the participant. I further attest that all questions asked 
by the participant were answered to the best of my knowledge. 
 
_______________________________________________________ 
__________________ 
Signature of Individual Obtaining Consent  
 
 
 
Date of Signature 
 
 
SIGNATURE OF THE PRINCIPAL INVESTIGATOR: 
I attest that I am aware of the enrollment of this subject in the study discussed in this consent 
document. 
 
_______________________________________________________ 
__________________ 
Signature of the Principal Investigator 
 
 
 
 
Date of Signature