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End-Stage Kidney DiseaseNCT03582592

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

A study testing Fluid Distribution Timetable in people with End-Stage Kidney Disease and Hemolysis, run by University of Santo Tomas Hospital, Philippines.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End-Stage Kidney Disease, Hemolysis, Nursing
What is being tested?
Fluid Distribution Timetable
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
No sites listed yet
Study dates
15 Sep 2016to 1 Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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

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.

Read the detailed description

End-stage renal disease (ESRD), defined as a condition in which the kidneys are damaged or cannot filter blood similar to a healthy kidney (Centers for Disease Control and Prevention, 2017), is a rising global dilemma. In fact, it has been a leading cause of morbidity and mortality worldwide, afflicting approximately 8% - 16% of the global population (Jha et al., 2013) and ranking eighth among the leading causes of death. It has also been acknowledged as a troublesome disorder causing a myriad of health-related problems (Lowney et al., 2015), financial burden (Bavanandan et al., 2016), and poor survival outcomes (Halle et al., 2016).

Hemodialysis, a form of renal replacement treatment, has been the mainstream management for patients with kidney diseases (Smeltzer et al., 2010) despite several health complications (Smeltzer et al., 2010; Lowney et al., 2015). However, dietary and fluid therapy are also necessary components of the management for patient with ESRD. A common concern among patients on hemodialysis is the non-adherence to fluid therapy. Although this management is simple, it remains a challenge to patients on hemodialysis because of several physiologic changes brought by ESRD. As a result, numerous problems such as fluid overload, electrolyte imbalances, and acid-base imbalances occur which are detrimental to the patient's overall health. Since patients on hemodialysis are the key players in promoting their health, it is, therefore, imperative to develop individualized and empowering strategies what will promote their adherence to fluid therapy. The proposed strategy in this study is the fluid distribution timetable, a simple and health promotive intervention involving scheduled distribution of pre-determined amounts of fluid intake on a daily basis. This intervention consider the various sources and usage of fluids per day and allocates fluid intake according to the patient's prescribed fluid restriction. 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 is a single-blind, single-center, randomized-controlled pilot study at the dialysis unit of a tertiary level government-owned institution in Quezon City, Philippines. Patients were randomly-allocated to receive fluid distribution timetable with standard care (intervention) or standard care alone (control). Random allocation of respondents was conducted using computer-generated sequences of randomly permuted blocks (sizes of three, four, and five) at our office. Randomization was carried out by an independent statistician and was stratified according to their sex. During the study period, treatment allocation was masked from site personnel and patients. Post-hoc power analysis for two group means, using GPower version 3.1, revealed that a sample size of 24 patients with a 1:1.20 group allocation ratio yields a power of 99% at a significance of 5% (two-sided) and detects an effect size of 0.80.

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. The treatment group, on the other hand, received a combination of the standard care and the intervention, 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. In designing the intervention, we selected three behavior-specific cognitions from the Health Promotion Model by Nola J. Pender: perceived benefits, barriers, and self-efficacy. These cognitions are modifiable determinants of behavior that promote well-being. As such, the fluid distribution timetable enumerated the advantages of adherence and the disadvantages of non-adherence to fluid restriction.

Adherence to fluid restriction was measured using two indicators - thirst and interdialytic weight gain - and were compared using One-way RM-MANOVA and MANCOVA. Thirst was measured using a self-reported questionnaire the Dialysis Thirst Inventory, while interdialytic weight gain computed using a calibrated calculator by subtracting post-dialysis weight at the end of the previous hemodialysis session from the pre-dialysis weight during the current hemodialysis session. 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.

Being tested
Fluid Distribution Timetable
Keywords
Fluid distribution timetable, Fluid restriction adherence, End-Stage Kidney Disease, Hemodialysis, Thirst, Interdialytic Weight Gain, Nursing
Medical subject headings
Kidney Failure, Chronic, Hemolysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluid Distribution TimetableBehavioural

    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.

Study groups in NCT03582592
Study groupRoleWhat they receive
Fluid Distribution Timetable (FDT) GroupExperimentalIt 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.
Receives: Behavioral: Fluid Distribution Timetable
Comparison GroupNo interventionIt 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 Weeks

  2. Interdialytic Weight Gain

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

    Measured: 4 Weeks

Secondary outcomes (8)
  1. Age

    It refers to the age of the respondent in years at the time of participation in the study.

    Measured: Week 1

  2. Sex

    It refers to the biological gender assignment of the respondent at the time of participation in the study.

    Measured: Week 1

  3. 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.

    Measured: Week 1

  4. Blood Pressure

    It refers to both the systolic and diastolic blood pressure, measured in mmHg, of the respondent.

    Measured: 4 Weeks

  5. Pulse Rate

    It refers to the number of heart beats per minute.

    Measured: 4 Weeks

  6. Respiratory Rate

    It refers to the number of respirations in minute of the respondent.

    Measured: 4 Weeks

  7. Edema Status

    This refers to the edema status of the respondent at the time of participation in the study.

    Measured: Week 1

  8. Ultrafiltration Goal

    It refer to the ultrafiltration status of the respondent and it is categorized into to: met goal and unmet goal.

    Measured: Week 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2018
  2. Study start15 Sep 2016
  3. Primary completion1 Dec 2016
  4. Study completion1 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03582592
Sponsor's protocol ID
USTCON-2016-SR39
Status last verified
Jun 2018
First submitted
15 Jun 2018
Last updated
11 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mina RJL, Lerma MB, Litan PLB, Milano AAL, Mojica ADR, Malong-Consolacion CP, Lerma EB, Macindo JRB, Torres GCS. Fluid distribution timetable on adherence to fluid restriction of patients with end-stage renal disease undergoing haemodialysis: Single-blind, Randomized-Controlled Pilot Study. J Adv Nurs. 2019 Jun;75(6):1328-1337. doi: 10.1111/jan.13964. Epub 2019 Mar 18.

    PubMed 30706521

Questions about this trial

What is this clinical trial studying?

A study testing Fluid Distribution Timetable in people with End-Stage Kidney Disease and Hemolysis, run by University of Santo Tomas Hospital, Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived Thirst (time frame: 4 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03582592, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.

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