HP Improves Sleep and Overall Survival Rate in Maintenance Hemodialysis Patients

Overview

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.

Full Title of Study: “Hemoperfusion in Combination With Hemodialysis for Improvement of Self-reported Sleep Disturbance and Overall Survival Rate in Maintenance Hemodialysis Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 1, 2017

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • survival
    • Time Frame: 2 years
    • increase overall survival rate

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Pudong Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jin HM, MD, Professor – Shanghai Pudong Hospital

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