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Recovery Time and Affecting Factors in Hemodialysis Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04274556
Enrollment
86
Registered
2020-02-18
Start date
2019-06-01
Completion date
2019-12-01
Last updated
2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dialysis; Complications, Life Quality

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.

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.

Interventions

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.

Sponsors

Istanbul Demiroglu Bilim University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Post-dialysis Recovery TimeUp to 7 daysBefore 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 HypotensionUp to 7 daysIt 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 SymptomsUp to 7 daysIt 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.

Countries

Turkey (Türkiye)

Participant flow

Participants by arm

ArmCount
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
86
Total86

Baseline characteristics

CharacteristicPost-dialysis Recovery Group
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
86 Participants
Race and Ethnicity Not Collected— Participants
Sex: Female, Male
Female
44 Participants
Sex: Female, Male
Male
42 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 86
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 86

Outcome results

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.

Time frame: Up to 7 days

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Post-dialysis Recovery GroupNumber of Participants With Intradialytic HypotensionExisting of intradialytic symptoms42 Participants
Post-dialysis Recovery GroupNumber of Participants With Intradialytic HypotensionAbsent of intradialytic symptoms44 Participants
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.

Time frame: Up to 7 days

ArmMeasureValue (MEAN)Dispersion
Post-dialysis Recovery GroupPost-dialysis Recovery Time278.02 minutesStandard Deviation 209.94
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.

Time frame: Up to 7 days

ArmMeasureValue (MEAN)Dispersion
Post-dialysis Recovery GroupRate of Dialysis Symptoms19.10 score on a scaleStandard Deviation 14.29

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026