Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome

NCT ID: NCT03523039

Last Updated: 2022-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-18
• Study Completion Date: 2022-03-01

Brief Summary

This prospective single-centre randomized control trial aims at evaluating the safety and efficacy of hemoadsorption with CytoSorb® in 40 patients with Post-Cardiac Arrest Syndrome admitted to the ICU.

Detailed Description

Patients presenting Post-Cardiac Arrest Syndrome (PCAS) in the 24 hours following their admission in Intensive Care Unit will be randomly assigned either to a control group (standard of care) either to a "Hemoadsorption" group. In the latter, the patient will be connected in the 6 hours following randomization to an extracorporeal circuit, in which a Cytosorb ® cartridge will be placed. The circuit will be set up in hemoperfusion mode. The therapy will take place for a minimum of 12 hours and a maximum of 24 hours. Anticoagulation will be achieved using a regional heparin-protamin regimen.

Blood samples will be collected at randomization, T1 (6 hours post-randomization), T2 (12 hours after randomization), T3 (24 hours after randomization), T4 (48 hours after randomization) and T5 (48 hours after randomization), to assess change in inflammatory cytokine levels.

Conditions

Cardiac Arrest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hemoadsorption

Hemoadsorption is performed using a CytoSorb® cartridge.

Group Type: EXPERIMENTAL

CytoSorb® Hemoadsorption

Intervention Type: DEVICE

The therapy is initiated within 6 hours from randomization and maintained for a minimum of 12 consecutive hours to a maximum of 24 consecutive hours.

Control

Post-cardiac arrest management will be conducted as per institutional protocols.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CytoSorb® Hemoadsorption

The therapy is initiated within 6 hours from randomization and maintained for a minimum of 12 consecutive hours to a maximum of 24 consecutive hours.

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

• Evidence for patient's refusal to participate in clinical trials
• Non commitment for ongoing medical therapy (imminent withdrawal of care)
• Cardiac arrest caused by hemorrhagic shock
• Contraindications to therapeutic heparinization
• Shock of primary cardiac origin (LVEF <20%)
• Platelet count <20 G/L
• Deep immunosuppression state, as defined by neutrophils <1 G/L or CD4 <200 /mm3
• Pregnancy
• Acute sickle cell crisis
• Refractory cardiac arrest with ECMO implantation
• Need for renal replacement therapy at time of randomization
• Concomitant enrolment in another study
• Non availability of the research team at time of eligibility at time of randomization

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

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Antoine Schneider

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antoine Schneider, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Locations

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

References

Monard C, Bianchi N, Poli E, Altarelli M, Debonneville A, Oddo M, Liaudet L, Schneider A. Cytokine hemoadsorption with CytoSorb(R) in post-cardiac arrest syndrome, a pilot randomized controlled trial. Crit Care. 2023 Jan 23;27(1):36. doi: 10.1186/s13054-023-04323-x.

Reference Type: DERIVED

PMID: 36691082 (View on PubMed)

Other Identifiers

ID 2018-00421

Identifier Type: -

Identifier Source: org_study_id