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

SARS-CoV-2 Infection Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05040737
• Other study ID #: Dial-COVID
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 17, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2021
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 31, 2021
• Est. primary completion date: February 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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).

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• SARS-CoV-2 Infection

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario de Valencia	Valencia	Valencian Community

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Inflammatory interleukins reduction	Inflammatory interleukins reduction maintenance with each membrane after a second dialysis	Days 5 and 8
Secondary	Inflammatory interleukins reduction (30 minutes)	Inflammatory interleukins percentage reduction 30 min after each session,	Days 1,3,5,8
Secondary	Populational characteristics	To describe the characteristics of haemodialysis population affected by COVID -19	Day 8