CRP Apheresis in Infarct-Related Cardiogenic Shock
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLeipzig Heart Science gGmbH
About this trial
Cardiogenic shock complicating acute myocardial infarction remains associated with high short-term mortality despite guideline-directed therapy. Systemic inflammation, particularly elevated C-reactive protein (CRP), may contribute to ongoing myocardial injury and organ dysfunction.
The CRP-SHOCK trial is an investigator-initiated, prospective, randomized, open-label, multicenter pilot study evaluating selective CRP apheresis as an adjunct to standard of care in patients with infarct-related cardiogenic shock. Patients are randomized to receive either standard therapy alone or standard therapy plus selective CRP apheresis using the PentraSorb®-CRP system.
The primary objective is to assess the effect of CRP apheresis on the CLIP score at 66 ± 8 hours after randomization. Secondary objectives include clinical outcomes, inflammatory biomarkers, and safety endpoints.
Eligibility criteria
Qualifiers
Cardiogenic shock complicating acute myocardial infarction with planned revascularization by percutaneous coronary intervention (PCI).
Systolic blood pressure <90 mmHg for >30 minutes or requirement of catecholamine infusion to maintain systolic blood pressure ≥90 mmHg, and
Signs of impaired organ perfusion (at least one of the following): Cold, clammy skin and extremities, Altered mental status, Oliguria with urine output <30 mL/hour, Arterial lactate >2 mmol/L
C-reactive protein (CRP) level ≥7 mg/L at baseline.
Disqualifiers
Fever (body temperature >38°C) or acute infection with fever within the last 14 days.
Chronic inflammatory disease.
Known history of severe hepatic failure.
Chronic kidney disease with creatinine clearance <30 mL/min/1.73 m² prior to hospital admission.
Trial design
Treatments tested in this trial
- Selective C-reactive protein apheresis (PentraSorb®-CRP)
- Standard of care
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Leipzig Heart Science gGmbH
Lead sponsor
Helios Health Institute GmbH
Collaborator
Heart Center Leipzig at University of Leipzig
Collaborator
Source ClinicalTrials.gov