Clinical trial NCT04667741: Post-dialysis Recovery Time and Affecting Factors Between Turkey and Portugal
Official title: A Comparative Study Between Turkey and Portugal: Post-dialysis Recovery Time and Affecting Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dialysis
Recovery Time
Lead sponsor: Istanbul Demiroglu Bilim University
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 294
Sex: ALL
Minimum age (years): 18
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 in turkey and Portugal

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.

Detailed description: 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. 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 4 weeks
measure: Anxiety at one month
timeFrame: up to 4 weeks
measure: Depression at one month
timeFrame: up to 4 weeks
measure: Rate of Headache at one month
timeFrame: up to 4 weeks
measure: Rate of dry mouth at one month
timeFrame: up to 4 weeks
measure: Rate of trouble falling asleep at one month
timeFrame: up to 4 weeks
measure: Hemodialysis Sessions Features
timeFrame: up to 4 weeks
measure: Biochemical variables at one month
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Demiroglu Bilim University
Study officials:
affiliation: Istanbul Demiroglu Bilim University
name: Nurten Ozen, Assoc. Prof.
role: STUDY_DIRECTOR
References:
citation: Umeukeje EM, Cavanaugh KL. Intradialytic Symptoms and Recovery Time: Thinking 'Outside the Box' to Improve Patients' Dialysis Experience. Kidney Med. 2020 Feb 28;2(2):98-101. doi: 10.1016/j.xkme.2020.02.001. eCollection 2020 Mar-Apr. No abstract available.
citation: Alvarez L, Brown D, Hu D, Chertow GM, Vassalotti JA, Prichard S. Intradialytic Symptoms and Recovery Time in Patients on Thrice-Weekly In-Center Hemodialysis: A Cross-sectional Online Survey. Kidney Med. 2019 Dec 20;2(2):125-130. doi: 10.1016/j.xkme.2019.10.010. eCollection 2020 Mar-Apr.
citation: Bossola M, Di Stasio E, Monteburini T, Parodi E, Ippoliti F, Cenerelli S, Santarelli S, Nebiolo PE, Sirolli V, Bonomini M, Antocicco M, Zuccala G, Laudisio A. Recovery Time after Hemodialysis Is Inversely Associated with the Ultrafiltration Rate. Blood Purif. 2019;47(1-3):45-51. doi: 10.1159/000492919. Epub 2018 Sep 19.