HP Improves Sleep and Overall Survival Rate in Maintenance Hemodialysis Patients

Not Applicable

Completed

• Conditions: Hemoperfusion
• Interventions: Device: hemoperfusion(HP)

• Registration Number: NCT03487146
• Lead Sponsor: Shanghai Pudong Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-01
• Primary Completion: 2017-08-01
• Study Completion: 2017-12-01
• Status Verified: 2018-03
• Study First Submitted: 2018-03-26
• Study First Submitted QC: 2018-04-02
• Study First Posted: 2018-04-03
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

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

Exclusion Criteria

• 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

3. he/she has received a short-term poor prognosis
4. he/she would be more than 80 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HD+HP(hemodialysis+hemoperfusion) group	hemoperfusion(HP)	HD+HP as active interventional group.HP was performed 1-2 times/per 2 weeks, and each session lasted for two hours.

Primary Outcome Measures

Name	Time	Method
improvement of self-reported sleep disturbance	2 years	Analysis of the sleep disturbance by using Pittsburgh Sleep Quality Index (PSQI) questionnaire

Secondary Outcome Measures

Name	Time	Method
survival	2 years	increase overall survival rate