Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome

NCT03523039 | Completed

• 1 other identifier: ID 2018-00421
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest

Keywords

Cardiac Arrest; Cytokine Hemoadsorption

Outcome Measures

Primary Outcomes (2)

• Change in cytokine levels

  Plasma levels reduction of the following inflammatory mediators: IL-1β,IL-1Ra, IL-6, IL-8, IL-10 and TNF-α.

  From baseline (randomization) to 72 hours after randomization

• Incidence of Treatment-Emergent Adverse Events

  Rate of intervention-related complications

  From beginning of hemoadsorption to 24 hours after the end of hemoadsorption, incidence of adverse events such as haemorrhagic complications, catheter-insertion related complications and anaphylactoid reactions

Secondary Outcomes (5)

• Vasopressor requirements

  From baseline (randomization) to 72 hours after randomization

• In-hospital mortality

  Day 14, 28 and 90 after randomization

• Shock reversal

  Within 24 hours from randomization

• Sequential Organ Failure Assessment Score (SOFA)

  Day 1 to 7 after randomization

• CRP and Procalcitonin Levels

  Day 1, 2, 3 after randomization

Study Arms (2)

Hemoadsorption

EXPERIMENTAL

Hemoadsorption is performed using a CytoSorb® cartridge.

Device: CytoSorb® Hemoadsorption

Control

NO INTERVENTION

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

Interventions

CytoSorb® Hemoadsorption 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.

Hemoadsorption

Eligibility Criteria

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 36691082 DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Antoine Schneider, MD, PhD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 14, 2018
• Study Start: February 18, 2019
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)