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

NCT ID: NCT05040737

Last Updated: 2021-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-17
• Study Completion Date: 2021-12-31

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.

Conditions

SARS-CoV-2 Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PS membrane versus PMMA membrane,

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación para la Investigación del Hospital Clínico de Valencia

OTHER

Sponsor Role: lead

Responsible Party

Mª Jesús Puchades

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain

Countries

Spain

Other Identifiers

Dial-COVID

Identifier Type: -

Identifier Source: org_study_id