Nursing Clinical Trial
Official title:
Fluid Distribution Timetable on Adherence to Fluid Restriction of Patients With End-Stage Renal Disease Undergoing Hemodialysis: A Single-Blind, Randomized-Controlled Pilot Study
Verified date | June 2018 |
Source | University of Santo Tomas Hospital, Philippines |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Fluid restriction is necessary among patients with chronic kidney disease. However, treatment adherence remains a challenge. Hence, this study determined the effects of a fluid distribution timetable on adherence to fluid restriction of patients with end-stage renal disease undergoing hemodialysis. This study used a single-blind, randomized-controlled pilot study design. Patients with end-stage renal disease were randomly-assigned using computer-generated sequences of randomly permuted blocks stratified according to sex to receive the fluid distribution timetable or standard care. Adherence to fluid restriction was measured using two indicators - thirst and interdialytic weight gain - and were compared using One-way RM-MANOVA and MANCOVA. Secondary outcomes included baseline patient demographic and clinical characteristics and were compared according to treatment allocation. Both groups were followed-up for four weeks, assessing outcome measures during the second hemodialysis session for each week.
Status | Completed |
Enrollment | 24 |
Est. completion date | December 1, 2016 |
Est. primary completion date | December 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients who were diagnosed with end stage renal disease (ESRD); - were oligoanuric (oliguria of <1mL/kg/hour or anuria over 6 hours); - had been on hemodialysis for at least 6 months; - were alert and oriented; and, - were scheduled for hemodialysis twice a week Exclusion Criteria: - Patients who were pregnant; - had a history of or has overt mental illness; - were lethargic, disoriented, or debilitated during recruitment; and, - had complicated medical conditions such as congestive heart failure and pulmonary congestion |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Santo Tomas Hospital, Philippines |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perceived Thirst | The Dialysis Thirst Inventory (DTI) measured perceived thirst among the participants. It is a 7-item questionnaire answered on 5-point Likert scale, with scores ranging from 7 to 35 and higher scores indicating higher thirst. No cut-off score is present for the questionnaire; however, higher scores are interpreted as higher perceived thirst. | 4 Weeks | |
Primary | Interdialytic Weight Gain | It is the net increase in body weight from previous post-dialysis weight measured in kilograms | 4 Weeks | |
Secondary | Age | It refers to the age of the respondent in years at the time of participation in the study. | Week 1 | |
Secondary | Sex | It refers to the biological gender assignment of the respondent at the time of participation in the study. | Week 1 | |
Secondary | Educational Attainment | It refers to the highest educational attainment of the respondent and it is categorized into 5: no formal education, primary education, secondary education, college level, and post-graduate level. | Week 1 | |
Secondary | Blood Pressure | It refers to both the systolic and diastolic blood pressure, measured in mmHg, of the respondent. | 4 Weeks | |
Secondary | Pulse Rate | It refers to the number of heart beats per minute. | 4 Weeks | |
Secondary | Respiratory Rate | It refers to the number of respirations in minute of the respondent. | 4 Weeks | |
Secondary | Edema Status | This refers to the edema status of the respondent at the time of participation in the study. | Week 1 | |
Secondary | Ultrafiltration Goal | It refer to the ultrafiltration status of the respondent and it is categorized into to: met goal and unmet goal. | Week 1 |
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