HP Improves Sleep and Overall Survival Rate in Maintenance Hemodialysis Patients

Hemoperfusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487146
• Other study ID #: ShanghaiPudongH1
• Status: Completed
• Phase: N/A
• First received: March 26, 2018
• Last updated: April 3, 2018
• Start date: May 1, 2015
• Est. completion date: December 1, 2017

Study information

• Verified date: March 2018
• Source: Shanghai Pudong Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: December 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemoperfusion

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pudong Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of self-reported sleep disturbance	Analysis of the sleep disturbance by using Pittsburgh Sleep Quality Index (PSQI) questionnaire	2 years
Secondary	survival	increase overall survival rate	2 years