Recovery Time and Affecting Factors in Hemodialysis Patients

NCT04274556 | Completed Results

• 1 other identifier: 03
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 2

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.

Conditions

Dialysis; Complications; Life Quality

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

Post-dialysis recovery group OTHER

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Demiroglu Bilim University: lead

Study Sites (2)

Demiroglu Bİlim University

Istanbul, Sisli, 34360, Turkey (Türkiye)

Location

Demiroglu Bilim University

Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 22941875 BACKGROUND

• 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.

  PMID: 28419668 BACKGROUND

• 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.

  PMID: 30860667 BACKGROUND

• 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.

  PMID: 33497021 DERIVED

Results Point of Contact

• Title: Nurten OZEN
• Organization: Demiroglu Bilim University

ozenurten@yahoo.com.tr

+90 212 213 64 86

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 15, 2020
• First Posted: February 18, 2020
• Study Start: June 1, 2019
• Primary Completion: July 30, 2019
• Study Completion: December 1, 2019
• Last Updated: April 19, 2021
• Results First Posted: May 21, 2020

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)