Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome

Cardiac Arrest Clinical Trial

— CATCH  

Official title:

Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome: a Pilot Study (The CATCH Trial: Post Cardiac Arrest Therapy With Cytosorb Hemoadsorption)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03523039
• Other study ID #: ID 2018-00421
• Status: Completed
• Phase: N/A
• Start date: February 18, 2019
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2022
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Post-Cardiac Arrest Syndrome

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cytokine levels	Plasma levels reduction of the following inflammatory mediators: IL-1ß,IL-1Ra, IL-6, IL-8, IL-10 and TNF-a.	From baseline (randomization) to 72 hours after randomization
Primary	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	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	From baseline (randomization) to 72 hours after randomization
Secondary	In-hospital mortality	All-cause mortality	Day 14, 28 and 90 after randomization
Secondary	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	Within 24 hours from randomization
Secondary	Sequential Organ Failure Assessment Score (SOFA)	Total Daily SOFA Score. The score ranges from 0 (best outcome) to 24 (worst outcome).	Day 1 to 7 after randomization
Secondary	CRP and Procalcitonin Levels		Day 1, 2, 3 after randomization