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Efficacy Trial of Fluid Distribution Timetable

NCT05797766 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-09-28

No results posted yet for this study

Summary

Nonadherence to fluid restriction is a significant issue among hemodialysis patients globally, with numerous adverse health outcomes. These outcomes include increased intradialytic weight gain, acid-base and electrolyte imbalances, and decreased mental health. This study aimed to determine the effects of a fluid distribution timetable on adherence to fluid restriction among patients with end-stage renal disease undergoing hemodialysis. The study utilized a single-blind, randomized-controlled efficacy trial design. Selected ESRD patients undergoing hemodialysis are then randomized using computer-generated sequences of randomly permuted blocks stratified according to sex to receive the intervention or the control group. Adherence to fluid restriction was measured using the dialysis thirst inventory and intradialytic weight gain. The variables were computed using One-way Repeated Measures Multivariate Analysis of Variance and Multivariate Analysis of Covariance. Secondary outcomes included baseline patient demographic profile and was compared according to group allocation. Both group were followed up for four weeks, assessing the outcome measures during the third hemodialysis session for each week

Conditions

  • End-stage Renal Disease

Interventions

BEHAVIORAL

Fluid Distribution Timetable

a scheduled distribution of predetermined amounts of fluid intake daily depicted in a 5x6 table. The timetable has three major columns. The first column has six-time points of a day with a four-hour interval. The second column, which was divided into four sub-columns, reflects the percentage of fluid allotment for food, activities, medication, and thirst encounters. The percentage of fluid allocation was computed based on the patient's prescribed fluid restriction, usual time of food intake per day, usual level of activity, time of medication intake, and common time they encounter thirst for a day. The third column indicates the converted percentage of fluid allotment into milliliters.

Sponsors & Collaborators

  • University of Santo Tomas Hospital

    collaborator UNKNOWN

  • University of Santo Tomas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-18
Primary Completion
2023-04-18
Completion
2023-05-05

Countries

  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05797766 on ClinicalTrials.gov