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

Primary Purpose

SARS-CoV-2 Infection

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PS membrane versus PMMA membrane,
Sponsored by
Fundación para la Investigación del Hospital Clínico de Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for SARS-CoV-2 Infection focused on measuring Haemodialysis, SARS-CoV-2 Infection, cytokines

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital Clínico Universitario de Valencia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Inflammatory interleukins reduction with two different dialysis membranes (PMMA and PS).
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).

Secondary Outcome Measures

Percentage of Inflammatory interleukins reduction
Inflammatory interleukins reduction maintenance with each membrane after a second dialysis
Inflammatory interleukins reduction (30 minutes)
Inflammatory interleukins percentage reduction 30 min after each session,
Populational characteristics
To describe the characteristics of haemodialysis population affected by COVID -19

Full Information

First Posted
August 1, 2021
Last Updated
September 9, 2021
Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT05040737
Brief Title
PMMA vs Polysulfone in SARS-CoV-2 Infection Hemodialysis Patients
Acronym
Dial-COVID
Official Title
Comparison of Two Types of Dialyzers (PMMA vs Polysulfone) on Cytokine Extraction in Hemodialysis Patients and COVID Infection. A Multicenter Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 17, 2020 (Actual)
Primary Completion Date
February 8, 2021 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection
Keywords
Haemodialysis, SARS-CoV-2 Infection, cytokines

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
PS membrane versus PMMA membrane,
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Inflammatory interleukins reduction with two different dialysis membranes (PMMA and PS).
Description
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).
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Percentage of Inflammatory interleukins reduction
Description
Inflammatory interleukins reduction maintenance with each membrane after a second dialysis
Time Frame
Days 5 and 8
Title
Inflammatory interleukins reduction (30 minutes)
Description
Inflammatory interleukins percentage reduction 30 min after each session,
Time Frame
Days 1,3,5,8
Title
Populational characteristics
Description
To describe the characteristics of haemodialysis population affected by COVID -19
Time Frame
Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
State/Province
Valencian Community
ZIP/Postal Code
4610
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

PMMA vs Polysulfone in SARS-CoV-2 Infection Hemodialysis Patients

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