CClinicalTrials.gg
Status unknownNCT05040737Dial-COVIDUpdated Sep 10, 2021

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

An interventional study of PS membrane versus PMMA membrane, in SARS-CoV-2 Infection, sponsored by Fundación para la Investigación del Hospital Clínico de Valencia. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-09-10.

Sponsored by Fundación para la Investigación del Hospital Clínico de Valencia · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Apr 2020, registered Aug 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • SARS-CoV-2 Infection

Keywords

  • Haemodialysis
  • SARS-CoV-2 Infection
  • cytokines
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 12 is below the median of 120 across 4,201 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia is the lead sponsor of 70 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • 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,

Interventions

  • DevicePS 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.

06

What researchers measure

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).

    Time frame: Day 8

Secondary outcomes

  1. Percentage of Inflammatory interleukins reduction

    Inflammatory interleukins reduction maintenance with each membrane after a second dialysis

    Time frame: Days 5 and 8

  2. Inflammatory interleukins reduction (30 minutes)

    Inflammatory interleukins percentage reduction 30 min after each session,

    Time frame: Days 1,3,5,8

  3. Populational characteristics

    To describe the characteristics of haemodialysis population affected by COVID -19

    Time frame: Day 8

07

Study locations

1 site
  • Hospital Clínico Universitario de Valencia
    Valencia, Valencian Community 4610, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05040737
Lead sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
Responsible party
Mª Jesús Puchades (MD PhD, Fundación para la Investigación del Hospital Clínico de Valencia) — Principal investigator
First posted
Sep 10, 2021
Start date
Apr 17, 2020
Primary completion
Feb 8, 2021
Completion
Dec 31, 2021 (estimated)
Last update
Sep 10, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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