Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome (CATCH)

V

Vaud University Hospital Center

Status

Completed

Conditions

Cardiac Arrest

Treatments

Device: CytoSorb® Hemoadsorption

Study type

Interventional

Funder types

Other

Identifiers

NCT03523039
ID 2018-00421

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

21 participants in 2 patient groups

Hemoadsorption
Experimental group
Description:
Hemoadsorption is performed using a CytoSorb® cartridge.
Treatment:
Device: CytoSorb® Hemoadsorption
Control
No Intervention group
Description:
Post-cardiac arrest management will be conducted as per institutional protocols.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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