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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: Device: CytoSorb® Hemoadsorption

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hemoadsorption; Hemoadsorption is performed using a CytoSorb® cartridge.	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.
No Intervention: Control; Post-cardiac arrest management will be conducted as per institutional protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
In-hospital mortality	All-cause mortality	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	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).	Day 1 to 7 after randomization
CRP and Procalcitonin Levels		Day 1, 2, 3 after randomization

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Antoine Schneider, MD, PhD, Centre Hospitalier Universitaire Vaudois

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2019
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: May 1, 2018
• First Posted (Actual): May 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Cardiac Arrest; Cytokine Hemoadsorption
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Postoperative Complications; Brain Injuries; Reperfusion Injury; Heart Arrest; Post-Cardiac Arrest Syndrome
• Other Study ID Numbers: ID 2018-00421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No