- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05040737
PMMA vs Polysulfone in SARS-CoV-2 Infection Hemodialysis Patients (Dial-COVID)
Comparison of Two Types of Dialyzers (PMMA vs Polysulfone) on Cytokine Extraction in Hemodialysis Patients and COVID Infection. A Multicenter Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Controlled, prospective, open-label trial with a total duration of 2 weeks to assess the clearance of inflammatory interleukins by different membranes in haemodialysis patients with COVID-19.
Patients will be dialysed according to the usual dialysis schedule of three weekly sessions. The study has a duration of 8 days in order to include 4 haemodialysis sessions. The first and third haemodialysis sessions will be dialysed with PS membrane and the second and fourth sessions with PMMA membrane, both dialysers with a surface area of 1.8 m2.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Valencian Community
-
Valencia, Valencian Community, Spain, 4610
- Hospital Clínico Universitario de Valencia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥18 years .
- Patient on chronic haemodialysis admitted to the hospital with a diagnosis of infection by COVID-19.
- Signature of informed consent or legal representative.
- Estimated duration of admission greater than 8 days (4 haemodialysis sessions).
- Patient with haemodynamic stability, understood as systolic blood pressure ≥ 100 mmHg.
Exclusion Criteria:
- Refusal to sign the consent form.
- Patients who for clinical reasons are unable to follow a regular dialysis schedule of three sessions per week.
- Allergy (documented or suspected) to either of the two membranes involved in the study.
- Patient with haemodynamic instability (Mean arterial pressure < 100 mmHg).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study Arm
Patients will be dialysed according to the usual dialysis schedule of three weekly sessions.
The study has a duration of 8 days in order to include 4 haemodialysis sessions.
The first and third haemodialysis sessions will be dialysed with PS membrane and the second and fourth sessions with PMMA membrane, both dialysers with a surface area of 1.8 m2.
|
Patients will be dialysed according to the usual dialysis schedule of three weekly sessions.
The study has a duration of 8 days in order to include 4 haemodialysis sessions.
The first and third haemodialysis sessions will be dialysed with PS membrane and the second and fourth sessions with PMMA membrane, both dialysers with a surface area of 1.8 m2.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Inflammatory interleukins reduction with two different dialysis membranes (PMMA and PS).
Time Frame: Day 8
|
To compare the percentage reduction of inflammatory interleukins measured at the beginning and end of haemodialysis in the same patient with COVID 19 infection dialysed with two different dialysis membranes (PMMA and PS).
|
Day 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Inflammatory interleukins reduction
Time Frame: Days 5 and 8
|
Inflammatory interleukins reduction maintenance with each membrane after a second dialysis
|
Days 5 and 8
|
Inflammatory interleukins reduction (30 minutes)
Time Frame: Days 1,3,5,8
|
Inflammatory interleukins percentage reduction 30 min after each session,
|
Days 1,3,5,8
|
Populational characteristics
Time Frame: Day 8
|
To describe the characteristics of haemodialysis population affected by COVID -19
|
Day 8
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dial-COVID
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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