Hand-carried Ultrasound for Ruling Out Hydronephrosis in Acute Kidney Injury and Acute Kidney Disease
Phase: NA
Conditions: Hydronephrosis, Ultrasound, Acute Kidney Injury
Sponsor: Washington University School of Medicine

 
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by the recipient that no unpublished information contained herein will be published or disclosed without prior written approval. 
 
    
 
 
RESEARCH PROTOCOL 
 
 
 
STUDY TITLE 
Hand-carried ultrasound for ruling out hydronephrosis in acute kidney injury and acute kidney 
disease  
 
 
 
 
 
 
PI Name: Fadi Tohme 
PI Title: Assistant Professor 
Washington University School of Medicine 
Department of Medicine 
E-mail: ftohme@wustl.edu 
 
 
 
 
Version Date:  3/26/2019 
 

 
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by the recipient that no unpublished information contained herein will be published or disclosed without prior written approval. 
 
    
 
 
1.  SYNOPSIS 
 
Study Title 
Hand-carried ultrasound for hydronephrosis  
Objective 
Determine if internal medicine trainees can rapidly and accurately rule out 
hydronephrosis using hand-carried ultrasound 
Study Period 
Planned enrollment duration: 18 months 
Planned study duration: 18 months
Number of Patients 
170
Study Treatment  
none 
Study Design 
Prospective Observational  
 
Inclusion and 
Exclusion Criteria 
List Inclusion and Exclusion Criteria for your study: 
 
Inclusion Criteria: 
 
Exclusion Criteria: 
1. Age >18 years  
2. Acute kidney injury or acute kidney 
disease 
1. End-stage renal disease 
3.  Retroperitoneal ultrasound ordered or 
performed within the last 4 hours 
  2. History of kidney transplantation  
 
3. Pregnant women 
 
4. Prisoners 
 
5. Patient unable to provide informed consent  
6. Morbid obesity (BMI >40) 
7. Current diagnosis of renal cell carcinoma  
8. Rash overlying scanning area (left or right flank) 
Measurements 
(1) Presence or absence of hydronephrosis on hand-carried renal ultrasound  
(2) Severity of hydronephrosis (only when present) on HCU  
Statistical 
Methodology 
Interobserver reliability/ kappa; Sensitivity, specificity, PPV and NPV of HCU 
performed by trainees compared to read by staff radiologist 

 
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by the recipient that no unpublished information contained herein will be published or disclosed without prior written approval. 
 
    
 
 
2.  STUDY PROTOCOL  
 
2.1 Background and Significance 
Point-of-care ultrasound (POCUS) is an increasingly popular imaging modality that helps clinicians 
establish or rule out diagnoses, monitor therapy and provide real-time procedural guidance.  The 
rapid availability, safety and low cost of POCUS have made it particularly useful in certain 
specialties, such as emergency medicine, critical care and trauma. The Focused Assessment with 
Sonography in Trauma (FAST) exam is a good example of the potential impact and wide 
applicability of POCUS in medical practice and is now performed worldwide and has supplemented 
CT as the first recommended imaging modality in the management algorithm of both stable and 
unstable trauma patients. POCUS is also gaining traction in medical education as an adjunct to 
physical examination, in the primary care setting, as well as in certain medical subspecialties.  
 
Hand-carried ultrasound (HCU), a type of POCUS that displays images either on a smart 
phone or on a tablet, makes obtaining real-time imaging more portable and less cumbersome for 
providers who care for patients in different locations. In a study of 157 consecutive inpatients, trainee 
cardiologists using HCU were able to identify a normal echo in 94% and a normal EF in 100% of 
cases. This translated into significant reductions in cost and departmental workload.  
 
Because renal structures are easily seen by ultrasound, enthusiasm for POCUS is increasing in 
the nephrology community, with terms such as “Point-of-care ultrasound in nephrology (POCUN) 
being recently carved out. POCUN has wide applications, including the assessment of volume status 
(inferior vena cava ultrasound, B-lines on lung ultrasound), hemodialysis access or obstructive 
kidney injury through the detection of hydronephrosis. 
 
Renal ultrasonography is most commonly ordered for patients with acute kidney injury, with a 
main focus on identifying obstruction of the collecting system, a rare but potentially reversible cause 
of acute kidney injury. While data is lacking regarding the use of POCUS to identify hydronephrosis 
in an inpatient setting, data from emergency-use of POCUS demonstrates the validity of using 
POCUS to evaluate for hydronephrosis. In a prospective observational study of emergency 
department (ED) patients with suspected renal colic compared computed tomography (CT) results 
with POCUS and found that hydronephrosis on POCUS was predictive of a ureteral stone 88% of the 
time. These findings suggested that POCUS can be used to first detect hydronephrosis and aid 
physicians in identifying patients with renal colic1. Another prospective observational study of 
emergency physicians without prior training on renal ultrasonography who underwent a short training 
program and then evaluated patients with presumed renal colic, acute pyelonephritis or documented 
renal failure with POCUS. Results of POCUS were compared with radiologist-read ultrasound and 
found that hydronephrosis was detected in 100% of cases and accurately ruled out in 71% of cases2.    
 
 
2.1.1 Preliminary Data 
 
None available 
 
2.2 Objective 

 
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by the recipient that no unpublished information contained herein will be published or disclosed without prior written approval. 
 
    
 
 
 
Evaluate the accuracy of HCU in ruling out hydronephrosis in patients with a diagnosis of acute 
kidney injury (AKI) or acute kidney disease (AKD) in an inpatient setting. We anticipate potential 
cost savings for patients and for the healthcare system.  
 
2.3 Patient Selection 
 
2.3.1 Inclusion Criteria 
Each subject must meet all of the following criteria: 
1. Age >18 years  
2. Acute kidney injury or acute kidney disease 
3.  Retroperitoneal ultrasound ordered or performed within the last 4 hours 
 
2.3.2 Exclusion Criteria 
Subjects will not be enrolled if any of the following criteria exist: 
 
 
 
2.4. Study Design 
 
Observational  
 
2.4.1 Study Procedures 
 
1. End-stage renal disease 
  2. History of kidney transplantation  
3. Pregnant women 
4. Prisoners 
5. Patient unable to provide informed consent  
6. Morbid obesity (BMI >40) 
7. Current diagnosis of renal cell carcinoma  
8. Rash overlying scanning area (left or right flank) 

 
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by the recipient that no unpublished information contained herein will be published or disclosed without prior written approval. 
 
    
 
 
The study team will identify potential participants based on inpatient orders placed in EPIC for a 
radiology-performed renal ultrasound. Once an order in EPIC has been placed for a renal ultrasound 
to be done by radiology on a patient that is admitted to Barnes Jewish Hospital, a team member will 
discuss the study with participants in person.  
 
All patients that fit inclusion/exclusion criteria will be invited to consent and take part in the study  
The recruiting investigator will meet individually with each patient and describe the study to them  
Patients will either be in the emergency department, on the floor (South or North campus in BJH) or 
in the ICU. Investigator will spend the necessary time to explain the study to each patient and answer 
all questions. 
Patients will be told that taking part in the study is purely voluntary and that they can decline to be 
involved. This will not affect their medical care.  
Patients will be told that they can withdraw from the study at any time after enrolling.  
Team member will make sure that patients interested in study participation are in a quiet area. Team 
member will review the consent and answer all study related questions.  
 
Upon consent of patient, patient’s age and gender with the assigned study code number will be 
recorded on enrollment log. Study code number, patient name and MRN will be written on bedside 
data collection sheet.  
 
One non-invasive hand-carried renal ultrasound will be performed the following way:     
MD performs right and left sided renal ultrasound and notes his findings on data collection sheet and 
places in envelope   
 
Each enrolled patient will have the following ultrasound images recorded within 4 hours of 
completion of the radiology-performed renal ultrasound:   
Right kidney longitudinal view  
Right kidney mid transverse view 
Left kidney longitudinal view  
Left kidney mid transverse view  
 
Each clinician will record their result (presence or absence of hydronephrosis, severity of 
hydronephrosis if present, technical ease or difficulty in obtaining ultrasound images) on a data 
collection form with the study number, patient name, date and time images were acquired, clinician 
initials, and comment section for any other observations. The clinician will place the completed form 
for their measurement in an envelope with the study number on the outside. 
 
2.4.2 Minimization of Bias 
 
There will be no specific gender or ethnic background for enrollment and the decision to approach for 
consent will be by convenience of team members.  
 
2.4.3 Pre-Study Period 
 
2.4.4 Study Period 

 
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by the recipient that no unpublished information contained herein will be published or disclosed without prior written approval. 
 
    
 
 
 
5/1/2019 to 10/31/2020 
 
Methods: 
 
2.4.6 Observations and Measurements 
 
1. Presence or absence of hydronephrosis in the right kidney  
2. Presence or absence of hydronephrosis in the left kidney  
3. If hydronephrosis present: severity of hydronephrosis (mild, moderate, severe)  
4. Time taken to obtain ultrasound images of both kidneys  
5. Technical difficulty of study as rated by operator (easy, relatively easy, challenging, very 
challenging)  
 
 
2.4.6.3 Primary Outcome Measures 
1. Sensitivity, specificity, positive and negative predictive value of HCU compared to radiology 
read (blinded when obtaining data) 
 
 
2.4.6.4 Secondary Outcome Measures 
1. Duration of obtained measurement(s) 
2. Interobserver reliability 
3. Potential cost reduction   
 
2.4.6.5   Statistical Methods 
 
2.4.6.6   Sample Size 
 
Assuming an alpha error of 0.05, marginal estimation error (d2) of 0.07, and prevalence of 90%, we 
determined that 170 patients were to be included to detect a specificity of absence of hydronephrosis 
to be 90%.  
 
2.5 Management of Intercurrent Events 
 
 
2.5.1 Adverse Experiences 
 
The investigator will closely monitor subjects for evidence of adverse events.  All adverse events will 
be reported and followed until satisfactory resolution.  The description of the adverse experience will 
include the time of onset, duration, intensity, etiology, relationship to the study intervention (none, 
unlikely, possible, probable, highly probable), and any treatment required. 
 

 
CONFIDENTIAL: This document is the intellectual property of Tohme.  Acceptance of this document constitutes the agreement 
by the recipient that no unpublished information contained herein will be published or disclosed without prior written approval. 
 
    
 
 
2.5.2 Premature Discontinuation 
 
If a subject withdraws from the study, the subject will be replaced in order to provide the required 
number of evaluable subjects.  Subjects will be withdrawn if the investigator decides that 
discontinuation is in the best interest of the subject, or the subject requests withdrawal from the study. 
 
2.5.3 Potential Risks 
 
There are minimal confidentiality risks. But all efforts will be made to minimize confidentiality risk 
such as: Renal ultrasound images conducted as part of the study will be conducted in private setting 
to the extent possible; Recruitment/consent will occur in a private setting; Participants will be able to 
ask questions in a private setting 
 
 
2.5.4 Procedures to Minimize Potential Risks 
 
There will be efforts to minimize breach of confidentiality risk, such as “minimum necessary” data 
collection, secured storage in redcap with password access.  
 
2.5.5   Data and Safety Monitoring Plan 
An expert colleague from the Department of Medicine, not involved in the study, will also be 
designated to serve in a monitoring capacity. Based on the small size and relatively low risks nature 
of the protocol, this person will review for adverse events once a month 
 
3.  HUMAN SUBJECTS RESEARCH 
 
3.1 Protection of Human Subjects 
 
The study will be conducted under appropriate Washington University Institutional Review Board 
protocols and consent forms approvals.  The study will be conducted under the supervision of the PI, 
a Board-Certified and GCP-certified nephrologist, and a mentor with several years experience in the 
conduct of human volunteer studies. 
 
3.2 Sources of Materials 
 
3.2.1 List of Protected Health Information Collected for Study 
 
Name 
DOB 
Hemodynamics (vital signs, laboratory values –Cr, HCO3, BUN) 
Comorbidities (diabetes, hypertension, CHF, CKD etc.) 
Results from recent limited or full retroperitoneal ultrasound  
 
 

 
CONFIDENTIAL: This document is the intellectual property of Tohme.  Acceptance of this document constitutes the agreement 
by the recipient that no unpublished information contained herein will be published or disclosed without prior written approval. 
 
    
 
 
3.2.2 Data Management 
 
Paper data will be obtained by a research coordinator and placed in a sealed envelope. The envelope 
and paper data will be kept with the research coordinator during data acquisition and be digitally 
transcribed into Redcap. Paper data will be kept in a locked cabinet in the Renal Division Office 
where only research personnel would have access in order to maintain confidentiality.  
 
3.3 Recruitment and Informed Consent 
Recruitment will occur at Barnes Jewish Hospital where potential subjects will be approached by a 
team member. The study team will identify potential participants based on information received 
about orders placed for an inpatient renal ultrasound. A team member will discuss the study with 
participants in person.  
 
All patients that fit inclusion/exclusion criteria will be invited to consent and take part in the study 
The recruiting investigator will meet individually with each patient and describe the study to them. 
Patients interested in study participation will have the opportunity to review the consent in a quiet 
area and study personnel will answer all study related questions. 
 
 
3.4 Potential Benefits of the Proposed Research to the Subjects and Others 
 
There is no benefit to individual subjects in this study.  Society may benefit from a better 
understanding of the role of hand-carried ultrasound in the daily clinical care of patients. 
 
 
3.5 Inclusion of Women 
 
As a matter of operational policy, our studies of volunteers routinely and deliberately include 
equivalent numbers of women and men. To ensure sufficient enrollment of women, we typically 
close enrollment to men once their quota has been filled.  This approach has been highly successful. 
However, the nature of the current study precludes enrollment of a set number of female or male 
patients since the main criteria for inclusion is acute kidney injury and having a renal ultrasound 
ordered. Women of childbearing potential are not excluded from our research protocols.  
 
3.6 Inclusion of Minorities 
 
All of our studies actively encourage the participation of minorities in the research.  Our minority 
recruiting typically matches the demographic composition of the Washington University community 
from which subjects will be recruited (78% white, 21% Black, <1 % Hispanic).  
 
3.7 Inclusion of Children 
 
 Children <18 yr will not be studied in these investigations because the research team is not trained in 
pediatrics and has no access to this patient population. 
 

 
CONFIDENTIAL: This document is the intellectual property of Tohme.  Acceptance of this document constitutes the agreement 
by the recipient that no unpublished information contained herein will be published or disclosed without prior written approval. 
 
    
 
 
4.  REFERENCES 
 
1. 
Leo, M. et al. Ultrasound vs. Computed Tomography for Severity of Hydronephrosis and Its 
Importance in Renal Colic. West. J. Emerg. Med. 18, 559–568 (2017). 
2. 
Javaudin, F. et al. Evaluation of a short formation on the performance of point-of-care renal 
ultrasound performed by physicians without previous ultrasound skills: prospective 
observational study. Crit. Ultrasound J. 9, 8–11 (2017).