HP Improves Sleep and Overall Survival Rate in Maintenance Hemodialysis Patients

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.

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Key information

Conditions

Hemoperfusion

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

duration of maintenance HD should be equal or more than 3 months,
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
he/she has received a short-term poor prognosis
he/she would be more than 80 years old

Treatment and study plan

hemoperfusion(HP)

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.

Primary outcomes

improvement of self-reported sleep disturbance

Time frame: 2 years

Analysis of the sleep disturbance by using Pittsburgh Sleep Quality Index (PSQI) questionnaire

Secondary outcomes

survival

Time frame: 2 years

increase overall survival rate

Sponsors and collaborators

Lead sponsor

Shanghai Pudong Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Apr 3, 2018
Registry last updated: Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed