Dialysis; ComplicationsNCT04274556

Recovery Time and Affecting Factors in Hemodialysis Patients

An observational study of Dialysis; Complications and Life Quality, run by Istanbul Demiroglu Bilim University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Dialysis; Complications, Life Quality
What is being tested?: Post-dialysis recovery group
How many people: 86 participants
Where: 2 sitesTurkey (Türkiye)
Study dates: 1 Jun 2019to 1 Dec 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

Demiroglu Bİlim University
Istanbul, Sisli, 34360
Demiroglu Bilim University
Istanbul, 34384

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Conditions: Dialysis; Complications, Life Quality
Being tested: Post-dialysis recovery group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Post-dialysis recovery groupOther
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Up to 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20191 Dec 2019

First posted18 Feb 2020
Study start1 Jun 2019
Primary completion30 Jul 2019
Study completion1 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Dialysis; ComplicationsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04274556
Sponsor's protocol ID: 03
Status last verified: Mar 2021
First submitted: 15 Feb 2020
Last updated: 19 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 22941875
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.
PubMed 28419668
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.
PubMed 30860667
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.
PubMed 33497021

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dialysis; Complications trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Do Biochemical Parameters and Intradialytic Symptoms Affect Post-dialysis Recovery Time?: A Cross-sectional Study
ClinicalTrials.gov ID: NCT04274556
Acronym / sponsor ID: 03
Conditions: Dialysis; Complications, Life Quality
Study type: Observational
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: Istanbul Demiroglu Bilim UniversityUniversity, hospital or other
Study start: 1 Jun 2019 (actual)
Primary completion: 30 Jul 2019 (actual)
Study completion: 1 Dec 2019 (actual)
First posted: 18 Feb 2020 (actual)
Results: Posted 21 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Post-dialysis recovery groupBefore 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.	Other	–

Primary outcome

Post-dialysis Recovery Time
Time frame: Up to 7 days
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.
Number of Participants With Intradialytic Hypotension
Time frame: Up to 7 days
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.
Rate of Dialysis Symptoms
Time frame: Up to 7 days
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.

Results and safety

Results posted to the registry on 21 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Post-dialysis Recovery Group	86	86

Primary outcome: Post-dialysis Recovery Time

Time frame: Up to 7 days. Mean (Standard Deviation). Unit: minutes

Measure	Post-dialysis Recovery Group n = 86
Value	278.02 (209.94)

Primary outcome: Number of Participants With Intradialytic Hypotension

Time frame: Up to 7 days. Count of participants. Unit: Participants

Measure	Post-dialysis Recovery Group n = 86
Existing of intradialytic symptoms	42
Absent of intradialytic symptoms	44

Primary outcome: Rate of Dialysis Symptoms

Time frame: Up to 7 days. Mean (Standard Deviation). Unit: score on a scale

Measure	Post-dialysis Recovery Group n = 86
Value	19.10 (14.29)

Adverse events

Time frame: up to 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Post-dialysis Recovery Group	0 of 86 (0%)	0 of 0	0 of 86

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22941875Bossola 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.
Background: PubMed 28419668Bossola 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.
Background: PubMed 30860667Davenport 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.
Derived from this study: PubMed 33497021Ozen 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.
Individual participant dataSharing planned: No

Related trials for Dialysis; Complications

Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruiting
Days-Off Versus Daily Initial Peritoneal Dialysis Prescription
Kidney Failure
RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
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Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Dialysis; Complications and Life Quality, run by Istanbul Demiroglu Bilim University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-dialysis Recovery Time (time frame: Up to 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04274556, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.