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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03487146
Enrollment
156
Registered
2018-04-03
Start date
2015-05-01
Completion date
2017-12-01
Last updated
2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemoperfusion

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.

Interventions

DEVICEhemoperfusion(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.

Sponsors

Shanghai Pudong Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
improvement of self-reported sleep disturbance2 yearsAnalysis of the sleep disturbance by using Pittsburgh Sleep Quality Index (PSQI) questionnaire

Secondary

MeasureTime frameDescription
survival2 yearsincrease overall survival rate

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026