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

NCT05040737 | Unknown

• 1 other identifier: Dial-COVID
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 Infection

Keywords

Haemodialysis; SARS-CoV-2 Infection; cytokines

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 8

Secondary Outcomes (3)

• Percentage of Inflammatory interleukins reduction

  Days 5 and 8

• Inflammatory interleukins reduction (30 minutes)

  Days 1,3,5,8

• Populational characteristics

  Day 8

Study Arms (1)

Study Arm

EXPERIMENTAL

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,

Interventions

PS membrane versus PMMA membrane, 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.

Study Arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (1)

Hospital Clínico Universitario de Valencia

Valencia, Valencia, 4610, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: August 1, 2021
• First Posted: September 10, 2021
• Study Start: April 17, 2020
• Primary Completion: February 8, 2021
• Study Completion: December 31, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-09

Locations

ES (1)