Recovery Time and Affecting Factors in Hemodialysis Patients

Dialysis; Complications Clinical Trial

Official title:

Do Biochemical Parameters and Intradialytic Symptoms Affect Post-dialysis Recovery Time?: A Cross-sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04274556
• Other study ID #: 03
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: March 2021
• 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 1, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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; Complications
• Life Quality

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	Sisli
Turkey	Demiroglu Bilim University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Demiroglu Bilim University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — 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 7 days
Primary	Number of Participants With Intradialytic Hypotension	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.	Up to 7 days
Primary	Rate of Dialysis Symptoms	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.	Up to 7 days