HP Improves Sleep and Overall Survival Rate in Maintenance Hemodialysis Patients

Hemoperfusion in Combination With Hemodialysis for Improvement of Self-reported Sleep Disturbance and Overall Survival Rate in Maintenance Hemodialysis Patients

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.

Study Overview

• Status: Completed
• Conditions: Hemoperfusion
• Intervention / Treatment: Device: hemoperfusion(HP)

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: HD(hemodialysis) group; HD group as conventional control arm
Active Comparator: HD+HP(hemodialysis+hemoperfusion) group; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement of self-reported sleep disturbance	Analysis of the sleep disturbance by using Pittsburgh Sleep Quality Index (PSQI) questionnaire	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival	increase overall survival rate	2 years

Collaborators and Investigators

• Sponsor: Shanghai Pudong Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: April 2, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: ShanghaiPudongH1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No