Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome

Centre Hospitalier Universitaire Vaudois21 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cardiac Arrest

Interventions

CytoSorb® HemoadsorptionDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Adult (≥18 years old) patients admitted to the ICU after CA, at risk of PACS as defined by the presence of at least one of the following characteristics (at any time within 24hrs of CA): * Need for a vasoconstrictor (norepinephrine dose \> 0.2 µg/kg/min to maintain MAP \> 60-70 mmHg, , or equivalent vasoconstrictor agent) for at least one hour * Serum lactate level \> 6 mmol/l * Time to ROSC \> 25 minutes 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

Locations (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: From baseline (randomization) to 72 hours after randomization

Incidence of Treatment-Emergent Adverse Events

Rate of intervention-related complications

Time frame: 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

Vasopressor requirements

Including the number of patients with a 50% decrease in the baseline vasopressor dose after 6, 12, 24, 36 and 48 hours, and the % of patients requiring a vasopressor dose increase within 24 hours of baseline

Time frame: From baseline (randomization) to 72 hours after randomization

In-hospital mortality

All-cause mortality

Time frame: Day 14, 28 and 90 after randomization

Shock reversal

Percentage of patients with shock reversal shock reversal being defined in the present study as a norepinephrine dose \<0.1μg/kg/min to maintain MAP \>60-70 mmHg and a serum lactate level ≤2 mmol/L

Time frame: Within 24 hours from randomization

Sequential Organ Failure Assessment Score (SOFA)

Total Daily SOFA Score. The score ranges from 0 (best outcome) to 24 (worst outcome).

Time frame: Day 1 to 7 after randomization

CRP and Procalcitonin Levels

Data from ClinicalTrials.gov

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