Clinical trial NCT04274556: Recovery Time and Affecting Factors in Hemodialysis Patients
Official title: Do Biochemical Parameters and Intradialytic Symptoms Affect Post-dialysis Recovery Time?: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dialysis; Complications
Life Quality
Lead sponsor: Istanbul Demiroglu Bilim University
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Being on HD for 4 hours a day on 3 days per week for at least 6 months and 18 years or older

Brief summary: 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.

Detailed description: The recovery time not only decreases the quality of life but also increases the risk of mortality and morbidity. As a prolonged recovery time affects both the patients and the healthcare professionals and caregivers, there has been increased interest on determining the modifiable treatment-related factors in the international literature. The patients are limited in their daily living activities at home and at work during this period and a significant amount of time is therefore required to go back to normal life.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Being on HD for 4 hours a day on 3 days per week for at least 6 months
* No communication problem
* Volunteering to participate to the study

Exclusion Criteria:

* Younger than 18 years
* Shorter being on HD for 4 hours a day on 3 days per week for at least 6 months
* Have communication problem
* Not volunteering to participate to the study

Primary outcomes:
measure: Post-dialysis Recovery Time
timeFrame: Up to 7 days
measure: Number of Participants With Intradialytic Hypotension
timeFrame: Up to 7 days
measure: Rate of Dialysis Symptoms
timeFrame: Up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Demiroglu Bİlim University
state: Sisli
city: Istanbul
country: Turkey
facility: Demiroglu Bilim University
Study officials:
References:
citation: Bossola M, Di Stasio E, Antocicco M, Silvestri P, Tazza L. Variables associated with time of recovery after hemodialysis. J Nephrol. 2013 Jul-Aug;26(4):787-92. doi: 10.5301/jn.5000198. Epub 2012 Aug 31.
citation: Bossola M, Marzetti E, Di Stasio E, Monteburini T, Cenerelli S, Mazzoli K, Parodi E, Sirolli V, Santarelli S, Ippoliti F, Nebiolo PE, Bonomini M, Melatti R, Vulpio C. Prevalence and associated variables of post-dialysis fatigue: Results of a prospective multicentre study. Nephrology (Carlton). 2018 Jun;23(6):552-558. doi: 10.1111/nep.13059.
citation: Davenport A, Guirguis A, Almond M, Day C, Chilcot J, Wellsted D, Farrington K. Comparison of characteristics of centers practicing incremental vs. conventional approaches to hemodialysis delivery - postdialysis recovery time and patient survival. Hemodial Int. 2019 Jul;23(3):288-296. doi: 10.1111/hdi.12743. Epub 2019 Mar 12.
citation: Ozen N, Cepken T, Tosun B. Do biochemical parameters and intradialytic symptoms affect post-dialysis recovery time? A prospective, descriptive study. Ther Apher Dial. 2021 Dec;25(6):899-907. doi: 10.1111/1744-9987.13624. Epub 2021 Feb 8.