NCT03487146

Brief Summary

Sleep disturbance has been long-standing torments in most of patients with maintenance hemodialysis (HD). In this study, we attempted to explore whether long-term hemoperfusion (HP) could improve sleep disorder and increase overall survival rate in HD patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
Last Updated

April 5, 2018

Status Verified

March 1, 2018

Enrollment Period

2.3 years

First QC Date

March 26, 2018

Last Update Submit

April 3, 2018

Conditions

Hemoperfusion

Outcome Measures

Primary Outcomes (1)

  • improvement of self-reported sleep disturbance

    Analysis of the sleep disturbance by using Pittsburgh Sleep Quality Index (PSQI) questionnaire

    2 years

Secondary Outcomes (1)

  • survival

    2 years

Study Arms (2)

HD(hemodialysis) group

NO INTERVENTION

HD group as conventional control arm

HD+HP(hemodialysis+hemoperfusion) group

ACTIVE COMPARATOR

HD+HP as active interventional group.HP was performed 1-2 times/per 2 weeks, and each session lasted for two hours.

Device: hemoperfusion(HP)

Interventions

hemoperfusion(HP)DEVICE

These patients were computer-matched into two groups, involving 100 patients with absolute HD vs. 100 cases with HD+HP.HP was performed 1-2 times/per 2 weeks, and each session lasted for two hours.Self-reported sleep disturbance was evaluated before and after observational time (two-year period), which lasted at least 7 hours based on the recommendations presented by National Institute of Health (NIH). Sleep efficiency (%) was calculated as the ratio of sleep duration to total time in bed, and was multiplied by 100.

HD+HP(hemodialysis+hemoperfusion) group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • duration of maintenance HD should be equal or more than 3 months,
  • patient's age should be equal or more than 18 years

You may not qualify if:

  • \- i) he/she diagnosed with malignant tumors, an active rheumatism, infectious diseases, or a severe heart failure ii) he/she would disagree with the study
  • he/she has received a short-term poor prognosis
  • he/she would be more than 80 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Hemoperfusion

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsSorption DetoxificationExtracorporeal CirculationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 3, 2018

Study Start

May 1, 2015

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

April 5, 2018

Record last verified: 2018-03