HP Improves Sleep and Overall Survival Rate in Maintenance Hemodialysis Patients

NCT ID: NCT03487146

Last Updated: 2018-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-01
• Study Completion Date: 2017-12-01

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.

Conditions

Hemoperfusion

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HD(hemodialysis) group

HD group as conventional control arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

hemoperfusion(HP)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pudong Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin HM, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ShanghaiPudongH1

Identifier Type: -

Identifier Source: org_study_id