Please select the eligibility criteria that correspond to the clinical trial below.
Title: Parenteral Hydration in Advanced Cancer Patients - A Randomized Controlled Trial
Brief Summary: The goal of this clinical research study is to learn whether being hydrated (given liquids) through a catheter in a vein or in the tissue under the skin can improve symptoms of dehydration.

Objectives:

1.1 Determine whether parenteral hydration is superior to placebo in improving symptoms associated with dehydration (such as fatigue, myoclonus, sedation, and hallucinations) in advanced cancer patients receiving hospice care.

1.2 Determine whether parenteral hydration is superior to placebo in delaying the onset or reducing the severity of delirium in patients with advanced cancer receiving hospice care.

1.3 Describe the meaning patients and primary caregivers attribute to dehydration and re-hydration at the end of patient's lives.


Options:
A: Inclusion Criteria:

* Hospital admission for highly complex elective surgery

Exclusion Criteria:

* History of cognitive impairment.
* A low score in Mini-Mental State Examination (MMSE): \<23 points if the patient has 6 or more years of schooling, and \<18 points if the patient has \<6 years of schooling.
* Severe communication disorder and cultural language limitation (language other than Spanish).
* Delirium on admission or prior to the start of the intervention (measured with CAM).
* Patient enrolled in another study
B: Inclusion criteria:

* Diagnosis of cancer
* Age ≥ 18 yr
* Estimated prognosis of ≤ 1 week
* Patient unable to maintain sufficient oral intake (1L / day)

Exclusion criteria:

* Patient clinically dehydrated
* Patient has hyperactive delirium ("terminal agitation") at present
* Patient has had hyperactive delirium ("terminal agitation") in the last 24hr
* Clinical indication for clinically-assisted hydration (e.g. hypercalcaemia)
* Clinical contra-indication to clinically-assisted hydration (e.g. cardiac failure)
* Clinical contra-indication to peripheral cannulation
* Intravenous fluids / subcutaneous fluids / total parenteral nutrition (TPN) / enteral feeding or fluids already being administered
* Patient likely to be transferred to another setting for end of life care (e.g. home, hospice)
C: Inclusion Criteria:

1. Patients with advanced cancer (local recurrence or metastatic disease) admitted to hospice care
2. Patients have reduced oral intake of fluids, as determined by clinical assessment.
3. Patients exhibit evidence of mild or moderate dehydration as defined by decreased skin turgor in subclavicular region (more than 2 seconds), plus a score of \>/= 2/5 in the clinical dehydration assessment
4. In addition to fatigue, (expected to be present in all patients based on our pilot study), patients must score \>/= 1 on a 0 to 10 scale (0=no symptom, 10= the worst possible symptom) of two of the three other target symptoms (hallucinations, sedation, and myoclonus) scored
5. Patients are 18 years of age or older
6. Patients have life expectancy of \>/= 1 week as determined by their treating physicians
7. Patients who score \< 13 (normal range) in the Memorial Delirium Assessment Scale (MDAS) and are able to give written informed consent
8. Patients must be able to tolerate the parenteral treatment application device (butterfly cannula or intravenous access)
9. Patients must have a primary caregiver
10. Patients must reside within 60 miles of M. D. Anderson Cancer Center. Exception to this is for patients referred from Odyssey Health Care of Conroe, patients referred from this site must reside within 75 miles of M.D. Anderson Cancer Center.
11. Inclusion criteria of family caregivers: The family caregiver is a person who is patient's spouse, parent, sibling. child or significant other
12. The family caregiver must reside with the patient and is responsible for the care of the patient. Exception to this is for patients who are admitted to In Patient hospice or nursing homes/rehabilitation centers and are under the care of the hospice.
13. The family caregiver must be 18 years of age or older
14. The family caregiver must be willing to be interviewed by the research nurse and sign written informed consent

Exclusion Criteria:

1. Patient's refuse to participate in the study or are not competent to give informed consent
2. Patients are suffering from severe dehydration defined as decreased blood pressure or low perfusion of limbs, decreased level of consciousness, or no urine output for 12 hours
3. Patients with history or clinical evidence of renal failure. Creatinine \>1.5 x \*Upper Limit of Normal. (M.D. Anderson Cr ULN=1.5 mg/dl). Therefore, a patient with Creatinine of (CR)\> 2.25 mg/dl will be excluded.
4. Patients with history or clinical evidence of congestive heart failure
5. Patients who are not able to complete the baseline assessment forms
6. Patients have history of bleeding disorders demonstrated by clinical evidence of active bleeding, hematuria, hematoma, ecchymoses, and petechiae
7. Patients with brain metastasis, leptomeningeal disease or primary brain tumors will be eligible for participation in this study as long as there is no evidence of altered mental status as demonstrated by a normal score on the Memorial Delirium Assessment Scale (MDAS).
8. The family caregiver refuses to participate in the study
9. The family caregiver has difficulty understanding the intent of the study
D: Inclusion criteria

* Age more than 60 years, Scheduled for elective hip or knee replacement surgery at least 4 working days after the preadmission clinic visit
* Possess cognitive and physical capability necessary to comprehend and complete the study questionnaires
* Proficient in English, reading level at Grade 6 (patient or accompanying person),
* Be accessible for follow-up via telephone, or via the Internet, Ability to provide informed consent

Exclusion criteria

* Conditions potentially interfering with comprehension and delivery of informed consent , Schizophrenia, anxiety disorders, poorly controlled depression, multiple psychiatric disorders
* Active psychosis within the last 3 months
* Current use of antipsychotic medication
* Dementia, and/or clinically significant neurological disorder (stroke, epilepsy, brain tumors, Parkinson's Disease etc.)
* History of drug or alcohol dependence or abuse within last 3 months
* Surgery that is two-staged involving more than one surgical procedure to be performed within the same hospitalization period
* Emergency surgery when preoperative testing is not possible
* Patients with prior diagnosis of sleep-related breathing disorder with CPAP treatment
* Patients who may have had sleep studies earlier may be included, if they have been lost to follow-up by a sleep physician, are not on treatment or are non-compliant to treatment (mean CPAP nightly use \<4 hours, or median nightly CPAP use \<50% of total sleep time),Severe tracheal or lung disease,Contraindication to CPAP face-mask, Central Sleep Apnea, Significant Cardiac disease(New York Heart Association Functional Class III and IV Severe Valvular Heart Disease, Dilated Cardiomyopathy, Implanted Cardiac Pacemaker, unstable angina)
* bMyocardial Infarction or Cardiac Surgery or Percutaneous coronary interventions within 3 months

Answer: C