Cardiac Arrest
Conditions
Keywords
Cardiac Arrest, Cytokine Hemoadsorption
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.
Interventions
DEVICECytoSorb® 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.
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cytokine levels | From baseline (randomization) to 72 hours after randomization | Plasma levels reduction of the following inflammatory mediators: IL-1β,IL-1Ra, IL-6, IL-8, IL-10 and TNF-α. |
| Incidence of Treatment-Emergent Adverse Events | 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 | Rate of intervention-related complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shock reversal | Within 24 hours from randomization | 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 |
| Vasopressor requirements | From baseline (randomization) to 72 hours after randomization | 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 |
| CRP and Procalcitonin Levels | Day 1, 2, 3 after randomization | — |
| Sequential Organ Failure Assessment Score (SOFA) | Day 1 to 7 after randomization | Total Daily SOFA Score. The score ranges from 0 (best outcome) to 24 (worst outcome). |
| In-hospital mortality | Day 14, 28 and 90 after randomization | All-cause mortality |
Countries
Switzerland
Outcome results
None listed