Efficacy Trial of Fluid Distribution Timetable

NCT05797766 | Completed Phase 3

• 1 other identifier: REC-2022-08-095-RN
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

End-stage Renal Disease; Fluid Distribution Timetable; Thirst; Interdialytic weight; Nephrology Nursing; Hemodialysis

Outcome Measures

Primary Outcomes (2)

• Perceived Thirst Score

  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

• Intradialytic Weight Gain

  It is the net increase in body weight from previous post-dialysis weight measured in kilograms

  4 Weeks

Secondary Outcomes (5)

• Age

  Week 1

• Sex

  Week 1

• Educational Attainment

  Week 1

• Edema Status

  Week 1

• Ultrafiltration Goal

  Week 1

Study Arms (2)

Treatment

EXPERIMENTAL

The fluid distribution timetable as defined by Mina et al. (2019) is 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.

Behavioral: Fluid Distribution Timetable

Control

NO INTERVENTION

Standard care that consists of 10 to 15 minutes of face-to-face health teaching of their treatment regimen including management of medication, vascular access, dietary and fluid, and hemodialysis schedule.

Interventions

Fluid Distribution Timetable BEHAVIORAL

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.

Treatment

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with End-stage renal disease
• Oliguric (urine output of less than 20ml/ hr)
• Aged 40 - 70 years old
• Had been on dialysis for at least 6 months
• Is alert and oriented
• With scheduled for hemodialysis thrice a week.

You may not qualify if:

• Pregnant patients
• Has a history or overt mental illness
• Patients with congestive heart failure

Sponsors & Collaborators

• University of Santo Tomas: lead
• University of Santo Tomas Hospital: collaborator

Study Sites (1)

University of Santo Tomas Hospital

Manila, 1008, Philippines

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: April 4, 2023
• Study Start: January 18, 2023
• Primary Completion: April 18, 2023
• Study Completion: May 5, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

PH (1)