Selective C-reactive protein apheresis (PentraSorb®-CRP)Standard of care
Selective C-reactive protein apheresis (PentraSorb®-CRP): Selective removal of circulating C-reactive protein using the PentraSorb®-CRP adsorber system as an adjunct to guideline-directed standard of care.
Standard of care: Guideline-directed medical and interventional treatment for cardiogenic shock complicating acute myocardial infarction.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Cardiogenic shock complicating acute myocardial infarction with planned revascularization by percutaneous coronary intervention (PCI).
* Cardiogenic shock defined as:
* 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.
* Age ≥18 years.
* Informed consent provided by the participant or, if the participant is unable to consent, inclusion after assessment and documentation of the presumed patient's will by two physicians (one independent), with informed consent obtained as soon as possible.
Exclusion Criteria:
* 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.
* Life expectancy \<12 months prior to cardiogenic shock.
* Participation in another interventional clinical trial.
* Pregnancy.
* Resuscitation duration \>30 minutes.
* Cardiogenic shock due to causes other than acute myocardial infarction.
* Onset of cardiogenic shock \>12 hours before randomization.
* Age \>80 years.
Primary outcome measure(s)
CLIP score — 66 ± 8 hours after randomization The CLIP score (Cystatin C, Lactate, Interleukin-6 and N-terminal pro B-type natriuretic peptide \[NT-proBNP\] score) is a biomarker-based risk score for predicting 30-day mortality in cardiogenic shock complicating acute myocardial infarction. It is calculated via a logistic regression model using the four biomarkers (Cystatin C, Lactate, Interleukin-6, and NT-proBNP), yielding a probability score ranging from 0 to 1 (or 0% to 100% when multiplied by 100). Higher scores indicate a higher probability of 30-day mortality, i.e., a worse outcome.
Trial sites (1)
Facility
City
Region
Status
Heart Center Leipzig at University of Leipzig
Leipzig
Saxony
More Leipzig Heart Science gGmbH trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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