PMMA vs Polysulfone in SARS-CoV-2 Infection Hemodialysis Patients (Dial-COVID)

September 9, 2021 updated by: Mª Jesús Puchades, Fundación para la Investigación del Hospital Clínico de Valencia

Comparison of Two Types of Dialyzers (PMMA vs Polysulfone) on Cytokine Extraction in Hemodialysis Patients and COVID Infection. A Multicenter Prospective Study

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.

Study Overview

Status

Active, not recruiting

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

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Valencian Community
      • Valencia, Valencian Community, Spain, 4610
        • Hospital Clínico Universitario de Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Device: PS membrane versus PMMA membrane,
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

This is where you will find people and organizations involved with this study.

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2020

Primary Completion (Actual)

February 8, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

August 1, 2021

First Submitted That Met QC Criteria

September 9, 2021

First Posted (Actual)

September 10, 2021

Study Record Updates

Last Update Posted (Actual)

September 10, 2021

Last Update Submitted That Met QC Criteria

September 9, 2021

Last Verified

September 1, 2021

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

No

Studies a U.S. FDA-regulated device product

No

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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