NCT04274556

Recovery Time and Affecting Factors in Hemodialysis Patients

Completed Results posted Last updated 19 April 2021

What this trial tests

trial testing Post-dialysis recovery group in Dialysis; Complications in 86 participants. Completed in 1 December 2019.

Timeline

1 June 2019

Primary endpoint
30 July 2019

1 December 2019

Quick facts

Lead sponsor	Istanbul Demiroglu Bilim University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	86
Start date	1 June 2019
Primary completion	30 July 2019
Estimated completion	1 December 2019
Sites	2 locations across Turkey (Türkiye)

Drugs / interventions tested

• Post-dialysis recovery group

Conditions studied

• Dialysis; Complications — all drugs for Dialysis; Complications →
• Life Quality — all drugs for Life Quality →

Sponsor

Istanbul Demiroglu Bilim University

Who can join

Adults 18 to 75, any sex, with Dialysis; Complications or Life Quality. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Post-dialysis Recovery Time Primary · Up to 7 days

Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account.

Group	Value	95% CI
Post-dialysis Recovery Group	278.02	± 209.94

Number of Participants With Intradialytic Hypotension Primary · Up to 7 days

It is defined in the European Best Practice Guideline (EBPG) as a decrease of 20 mmHg or more in the systolic blood pressure or 10 mmHg or more in the mean arterial blood pressure together with symptoms requiring nursing intervention.

Existing of intradialytic symptoms

Group	Value	95% CI
Post-dialysis Recovery Group	42

Absent of intradialytic symptoms

Group	Value	95% CI
Post-dialysis Recovery Group	44

Rate of Dialysis Symptoms Primary · Up to 7 days

It was identified with Dialysis Symptom Index (DSI). DSI consists of 30 items. We queried the subjects regarding symptoms in the last 7 days. The effect was evaluated with a Likert type scale from 0 to 4, representing "not at all" to "significantly". The total score of the DSI ranges from 0 to 150. A score of zero reflects no symptoms while increasing total scores reflect increasing effects of the symptoms.

Group	Value	95% CI
Post-dialysis Recovery Group	19.10	± 14.29

Sponsor's own description

Patients undergoing hemodialysis (HD) can experience symptoms such as lassitude, pain, muscle cramps, nausea, vomiting, constipation, diarrhea, rash, skin dryness, sleep disorders, and emotional and sexual problems after the treatment. Many chronic HD patients do not feel well after the treatment sessions and need some time to recover. This recovery time is defined as the time required to recover from the feelings of lassitude and fatigue.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Do biochemical parameters and intradialytic symptoms affect post-dialysis recovery time? A prospective, descriptive study.
   Ozen N, Cepken T, Tosun B. · · 2021 · cited 6× · PMID 33497021 · DOI 10.1111/1744-9987.13624