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Fluid Distribution Timetable on Adherence to Fluid Restriction of Patients With End-Stage Renal Disease on Hemodialysis

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ClinicalTrials.gov Identifier: NCT03582592
Recruitment Status : Completed
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Rame John L. Mina, University of Santo Tomas Hospital, Philippines

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
End-Stage Kidney Disease Hemolysis Nursing Behavioral: Fluid Distribution Timetable Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
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
Actual Study Start Date : September 15, 2016
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fluid Distribution Timetable (FDT) Group
It is the fluid distribution timetable. It is a scheduled distribution of pre-determined amounts of fluid intake on a daily basis depicted via a 5x6 table. The timetable includes three major columns. The first column has six timepoints of a day with a four-hour interval. The second column, which was further 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 intakes in a day, usual level of activity, time of medication intake, and common time they encounter thirst in a day. Lastly, the third column indicates the converted percentages of fluid allotment in milliliters.
Behavioral: Fluid Distribution Timetable
It is a scheduled distribution of pre-determined amounts of fluid intake on a daily basis depicted via a 5x6 table. The timetable includes three major columns. The first column has six timepoints of a day with a four-hour interval. The second column, which was further 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 intakes in a day, usual level of activity, time of medication intake, and common time they encounter thirst in a day. Lastly, the third column indicates the converted percentages of fluid allotment in milliliters.

No Intervention: Comparison Group
It is the standard of care that served as the intervention. The control group received the standard care for patients on hemodialysis. The standard care involves a 10 -15-minute face-to-face health teaching of their treatment regimen including pharmacologic management, dialysis schedule, dietary and fluid restrictions or nutritional therapy, care for vascular access, and other necessary lifestyle modifications.



Primary Outcome Measures :
  1. Perceived Thirst [ Time Frame: 4 Weeks ]
    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.

  2. Interdialytic Weight Gain [ Time Frame: 4 Weeks ]
    It is the net increase in body weight from previous post-dialysis weight measured in kilograms


Secondary Outcome Measures :
  1. Age [ Time Frame: Week 1 ]
    It refers to the age of the respondent in years at the time of participation in the study.

  2. Sex [ Time Frame: Week 1 ]
    It refers to the biological gender assignment of the respondent at the time of participation in the study.

  3. Educational Attainment [ Time Frame: Week 1 ]
    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.

  4. Blood Pressure [ Time Frame: 4 Weeks ]
    It refers to both the systolic and diastolic blood pressure, measured in mmHg, of the respondent.

  5. Pulse Rate [ Time Frame: 4 Weeks ]
    It refers to the number of heart beats per minute.

  6. Respiratory Rate [ Time Frame: 4 Weeks ]
    It refers to the number of respirations in minute of the respondent.

  7. Edema Status [ Time Frame: Week 1 ]
    This refers to the edema status of the respondent at the time of participation in the study.

  8. Ultrafiltration Goal [ Time Frame: Week 1 ]
    It refer to the ultrafiltration status of the respondent and it is categorized into to: met goal and unmet goal.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582592


Sponsors and Collaborators
University of Santo Tomas Hospital, Philippines
Investigators
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Principal Investigator: Rame John L Mina, BSN, RN UST College of Nursing
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rame John L. Mina, Student Nurse, University of Santo Tomas Hospital, Philippines
ClinicalTrials.gov Identifier: NCT03582592    
Other Study ID Numbers: USTCON-2016-SR39
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rame John L. Mina, University of Santo Tomas Hospital, Philippines:
Fluid distribution timetable
Fluid restriction adherence
End-Stage Kidney Disease
Hemodialysis
Thirst
Interdialytic Weight Gain
Nursing
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Hemolysis
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Pathologic Processes