| Title: |
Safety and Efficacy of Human Chorionic Gonadotropin Hormone-Derivative EA-230 in Cardiac Surgery Patients: A Randomized Double-Blind Placebo-Controlled Study |
| Authors: |
van Groenendael, Roger; Beunders, Remi; Hemelaar, Pleun; Hofland, Jan; Morshuis, Wim J.; van der Hoeven, Johannes G.; Gerretsen, Jelle; Wensvoort, Gert; Kooistra, Emma J.; Claassen, Wout J.; Waanders, Denise; Lamberts, Maud G. A.; Buijsse, Leonie S. E.; Kox, Matthijs; van Eijk, Lucas T.; Pickkers, Peter |
| Source: |
van Groenendael, R, Beunders, R, Hemelaar, P, Hofland, J, Morshuis, W J, van der Hoeven, J G, Gerretsen, J, Wensvoort, G, Kooistra, E J, Claassen, W J, Waanders, D, Lamberts, M G A, Buijsse, L S E, Kox, M, van Eijk, L T & Pickkers, P 2021, 'Safety and Efficacy of Human Chorionic Gonadotropin Hormone-Derivative EA-230 in Cardiac Surgery Patients: A Randomized Double-Blind Placebo-Controlled Study', Critical Care Medicine, pp. 790-803. https://doi.org/10.1097/CCM.0000000000004847 |
| Publication Year: |
2021 |
| Description: |
OBJECTIVES: To determine the safety and efficacy of human chorionic gonadotropin hormone-derivative EA-230 in cardiac surgery patients. Cardiac surgery induces systemic inflammation and may impair renal function, affecting patient outcome. EA-230 exerted immunomodulatory and renoprotective effects in preclinical models and was safe and showed efficacy in phase I and II human studies. DESIGN: Double-blinded, placebo-controlled, randomized study. SETTING: Collaboration of the Cardiothoracic Surgery, Anesthesiology, and the Intensive Care departments of a tertiary hospital in the Netherlands. PATIENTS: One hundred eighty patients undergoing an on-pump coronary artery bypass procedure with or without concomitant valve surgery. INTERVENTIONS: Ninety mg/kg/hr EA-230 or placebo administered during surgery. MEASUREMENTS AND MAIN RESULTS: During the study, no safety concerns emerged. EA-230 did not modulate interleukin-6 plasma concentrations (area under the curve 2,730 pg/mL × hr [1,968-3,760] vs 2,680 pg/mL × hr [2,090-3,570] for EA-230 and placebo group, respectively; p = 0.80). Glomerular filtration rate increased following surgery (mean ± sem increase in the EA-230 vs placebo groups: glomerular filtration rateiohexolmeasured using iohexol plasma clearance: 19 ± 2 vs 16 ± 2 mL/min/1.73 m2; p = 0.13 and estimated glomerular filtration rate with the Modification of Diet in Renal Disease equation using creatinine: 6 ± 1 vs 2 ± 1 mL/min/1.73 m2; p = 0.01). The "injury" stage of the Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease criteria for acute kidney injury was 7% in the EA-230 group versus 18% in the placebo group (p = 0.07). In addition, EA-230-treated patients had a less positive fluid balance compared with placebo-treated patients (217 ± 108 vs 605 ± 103 mL; p = 0.01), while the use of vasoactive agents was similar in both groups (p = 0.39). Finally, hospital length of stay was shorter in EA-230 treated patients (8 d [7-11] vs 10 d [8-12]; p = 0.001). Efficacy results were more ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| ISSN: |
0090-3493; 1530-0293 |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/33591006; info:eu-repo/semantics/altIdentifier/pissn/0090-3493; info:eu-repo/semantics/altIdentifier/eissn/1530-0293 |
| DOI: |
10.1097/CCM.0000000000004847 |
| Availability: |
https://research.vumc.nl/en/publications/9d69bf4e-48a6-4479-a777-13ee6ab82f93; https://doi.org/10.1097/CCM.0000000000004847; https://www.scopus.com/pages/publications/85104369709 |
| Rights: |
info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.85EC727A |
| Database: |
BASE |