Trial Outcomes & Findings for Recovery Time and Affecting Factors in Hemodialysis Patients (NCT NCT04274556)

NCT ID: NCT04274556

Last Updated: 2021-04-19

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

86 participants

Primary outcome timeframe

Up to 7 days

Results posted on

2021-04-19

Participant Flow

Participant milestones

Participant milestones
Measure
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
Overall Study
STARTED
86
Overall Study
COMPLETED
86
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Post-dialysis Recovery Group
n=86 Participants
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
Age, Categorical
<=18 years
0 Participants
n=86 Participants
Age, Categorical
Between 18 and 65 years
86 Participants
n=86 Participants
Age, Categorical
>=65 years
0 Participants
n=86 Participants
Sex: Female, Male
Female
44 Participants
n=86 Participants
Sex: Female, Male
Male
42 Participants
n=86 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Post-dialysis Recovery Group
n=86 Participants
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
Post-dialysis Recovery Time
278.02 minutes
Standard Deviation 209.94

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Post-dialysis Recovery Group
n=86 Participants
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
Existing of intradialytic symptoms
42 Participants
Number of Participants With Intradialytic Hypotension
Absent of intradialytic symptoms
44 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Post-dialysis Recovery Group
n=86 Participants
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
Rate of Dialysis Symptoms
19.10 score on a scale
Standard Deviation 14.29

Adverse Events

Post-dialysis Recovery Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nurten OZEN

Demiroglu Bilim University

Phone: +90 212 213 64 86

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place