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HP Improves Sleep and Overall Survival Rate in Maintenance Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT03487146
Recruitment Status : Completed
First Posted : April 3, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Jin HM, MD, Shanghai Pudong Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hemoperfusion Device: hemoperfusion(HP) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hemoperfusion in Combination With Hemodialysis for Improvement of Self-reported Sleep Disturbance and Overall Survival Rate in Maintenance Hemodialysis Patients
Actual Study Start Date : May 1, 2015
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. improvement of self-reported sleep disturbance [ Time Frame: 2 years ]
    Analysis of the sleep disturbance by using Pittsburgh Sleep Quality Index (PSQI) questionnaire


Secondary Outcome Measures :
  1. survival [ Time Frame: 2 years ]
    increase overall survival rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Jin HM, MD, Professor, Shanghai Pudong Hospital
ClinicalTrials.gov Identifier: NCT03487146    
Other Study ID Numbers: ShanghaiPudongH1
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No