Post-dialysis Recovery Time and Affecting Factors Between Turkey and Portugal

Dialysis Clinical Trial

Official title:

A Comparative Study Between Turkey and Portugal: Post-dialysis Recovery Time and Affecting Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04667741
• Other study ID #: 12869
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: September 2022
• Source: Istanbul Demiroglu Bilim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: July 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dialysis
• Recovery Time

Intervention

Other:
• Post-dialysis recovery group
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.

Locations

Country	Name	City	State
Turkey	Demiroglu Bilim University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Demiroglu Bilim University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

Bossola M, Di Stasio E, Monteburini T, Parodi E, Ippoliti F, Cenerelli S, Santarelli S, Nebiolo PE, Sirolli V, Bonomini M, Antocicco M, Zuccalà 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-dialysis Recovery Time	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.	up to 4 weeks
Primary	Anxiety at one month	It will be assessed with Hospital Anxiety and Depression Scale. This scale, which has a two-factor structure is comprised of 14 items. Seven of these items assess the anxiety status and the remaining seven assess depression.; Each item is scored on a four-point scale. Total score ranges between 0 and 21 for anxiety and depression. Scores between 0 and 7 indicate normal emotional status.	up to 4 weeks
Primary	Depression at one month	It will be assessed with Hospital Anxiety and Depression Scale. This scale, which has a two-factor structure is comprised of 14 items. Seven of these items assess the anxiety status and the remaining seven assess depression.; Each item is scored on a four-point scale. Total score ranges between 0 and 21 for anxiety and depression. Scores between 0 and 7 indicate normal emotional status.	up to 4 weeks
Primary	Rate of Headache at one month	The patients will tell the living of headache to the investigators at the end of the one month. The answer will be "yes" or "no".	up to 4 weeks
Primary	Rate of dry mouth at one month	The patients will tell the living of dry mouth to the investigators at the end of the one month. The answer will be "yes" or "no".	up to 4 weeks
Primary	Rate of trouble falling asleep at one month	The patients will tell the living of trouble falling asleep to the investigators at the end of the one month. The answer will be "yes" or "no".	up to 4 weeks
Primary	Hemodialysis Sessions Features	Before and after the hemodialysis sessions, the patients were asked by investigators about dialysate bicarbonate concentration in mmol/L	up to 4 weeks
Primary	Biochemical variables at one month	After one month urea reduction rate (%) were aken from the patients' medical record	up to 4 weeks