HemoperfusionNCT03487146
HP Improves Sleep and Overall Survival Rate in Maintenance Hemodialysis Patients
A study testing hemoperfusion(HP) in people with Hemoperfusion, run by Shanghai Pudong Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemoperfusion
- What is being tested?
- hemoperfusion(HP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- duration of maintenance HD should be equal or more than 3 months,
- patient's age should be equal or more than 18 years
Who cannot join
- 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
About this study
Official title: Hemoperfusion in Combination With Hemodialysis for Improvement of Self-reported Sleep Disturbance 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.
- Conditions
- Hemoperfusion
- Being tested
- hemoperfusion(HP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| HD(hemodialysis) group | No intervention | HD group as conventional control arm |
| HD+HP(hemodialysis+hemoperfusion) group | Active comparator | HD+HP as active interventional group.HP was performed 1-2 times/per 2 weeks, and each session lasted for two hours. Receives: Device: hemoperfusion(HP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of self-reported sleep disturbance
Analysis of the sleep disturbance by using Pittsburgh Sleep Quality Index (PSQI) questionnaire
Measured: 2 years
Secondary outcomes (1)
survival
increase overall survival rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start1 May 2015
- Primary completion1 Aug 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemoperfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pudong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin HM, MD, Shanghai Pudong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487146
- Sponsor's protocol ID
- ShanghaiPudongH1
- Status last verified
- Mar 2018
- First submitted
- 26 Mar 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemoperfusion in Combination With Hemodialysis for Improvement of Self-reported Sleep Disturbance and Overall Survival Rate in Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03487146
- Acronym / sponsor ID
- ShanghaiPudongH1
- Conditions
- Hemoperfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Shanghai Pudong HospitalUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HD(hemodialysis) group | No intervention | –HD group as conventional control arm |
| HD+HP(hemodialysis+hemoperfusion) group | Active comparator | Device: hemoperfusion(HP)HD+HP as active interventional group.HP was performed 1-2 times/per 2 weeks, and each session lasted for two hours. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- duration of maintenance HD should be equal or more than 3 months,
- patient's age should be equal or more than 18 years
Key exclusion criteria (3 listed)
- he/she has received a short-term poor prognosis
- he/she would be more than 80 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | HD+HP(hemodialysis+hemoperfusion) group |
Primary outcome
improvement of self-reported sleep disturbance
Time frame: 2 years
Analysis of the sleep disturbance by using Pittsburgh Sleep Quality Index (PSQI) questionnaire
1 secondary outcome
survival
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
Related trials for Hemoperfusion
Recruiting
Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis
Pancreatitis, Acute
Recruiting
Efferon LPS Hemoadsorption in in Patients With Thermal Burns
Burns
Not yet recruiting
HOPE-Sepsis: Hemoadsorption Therapy for Sepsis
Sepsis and Septic Shock
Recruiting
Efferon CT Hemoadsorption for Cardiogenic Shock in Acute Myocardial Infarction
Myocardial Infarction, Cardiogenic Shock
Enrolling by invitation
EAA-Guided AN69-oXiris and PMX-HP Therapy in Septic Patients
Hemoperfusion, Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing hemoperfusion(HP) in people with Hemoperfusion, run by Shanghai Pudong Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of self-reported sleep disturbance (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.