Status:
COMPLETED
Parenteral Hydration in Advanced Cancer Patients
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Advanced Cancer
Dehydration
Eligibility:
All Genders
18+ years
Phase:
NA
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. Objective...
Detailed Description
For Caregivers: Symptoms of dehydration may include fatigue, muscle contractions, the need for sedation (calming medication), and hallucinations (where something is sensed that is not actually there)...
Eligibility Criteria
Inclusion
- Patients with advanced cancer (local recurrence or metastatic disease) admitted to hospice care
- Patients have reduced oral intake of fluids, as determined by clinical assessment.
- 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
- 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
- Patients are 18 years of age or older
- Patients have life expectancy of \>/= 1 week as determined by their treating physicians
- Patients who score \< 13 (normal range) in the Memorial Delirium Assessment Scale (MDAS) and are able to give written informed consent
- Patients must be able to tolerate the parenteral treatment application device (butterfly cannula or intravenous access)
- Patients must have a primary caregiver
- 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.
- Inclusion criteria of family caregivers: The family caregiver is a person who is patient's spouse, parent, sibling. child or significant other
- 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.
- The family caregiver must be 18 years of age or older
- The family caregiver must be willing to be interviewed by the research nurse and sign written informed consent
Exclusion
- Patient's refuse to participate in the study or are not competent to give informed consent
- 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
- 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.
- Patients with history or clinical evidence of congestive heart failure
- Patients who are not able to complete the baseline assessment forms
- Patients have history of bleeding disorders demonstrated by clinical evidence of active bleeding, hematuria, hematoma, ecchymoses, and petechiae
- 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).
- The family caregiver refuses to participate in the study
- The family caregiver has difficulty understanding the intent of the study
Key Trial Info
Start Date :
January 9 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT00423722
Start Date
January 9 2007
End Date
May 1 2013
Last Update
March 12 2024
Active Locations (5)
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1
Odyssey Healthcare of Conroe
Conroe, Texas, United States, 77304
2
Houston Hospice and Palliative Care System
Houston, Texas, United States, 77030
3
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
4
Odyssey Healthcare of Houston
Houston, Texas, United States, 77054