Safety and Efficacy of Human Chorionic Gonadotropin Hormone-Derivative EA-230 in Cardiac Surgery Patients: A Randomized Double-Blind Placebo-Controlled Study.

ABSTRACT:

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-23

SUBMITTER: van Groenendael R 

PROVIDER: S-EPMC8043513 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature