Introduction: Despite advances in revascularization and mechanical support, cardiogenic shock (CS) remains a highly morbid clinical state with 30-day mortality approaching 50%. Therapeutic hypothermia (TH) has been demonstrated to improve hemodynamics and reduce inflammation in small studies, but prospective randomized data is limited. We aimed to assess the safety and hemodynamic effects of TH (33 °C for 24 hours) in patients with CS. Methods: A total of 20 patients in CS were randomized to either TH plus standard therapy or standard therapy alone in this pilot study. Patients randomized to TH were cooled and rewarmed via intravenous cooling catheter. The primary safety endpoint was a composite of bradycardia requiring treatment, bleeding requiring transfusion as a result of catheter placement or secondary to resulting coagulopathy, shivering, hyperglycemia requiring insulin for non-diabetic patients, electrolyte derangement unexplained by other therapies, and complications from cooling catheter insertion. Secondary endpoints included hemodynamic parameters (cardiac output, pulmonary artery pressure, systemic vascular resistance, and cardiac power index). Results: There were no statistically significant differences in the composite analysis of prespecified safety outcomes (3 events in TH group vs 0 events in control group, p = 0.24). Patients randomized to TH demonstrated a statistically significant increase in cardiac index (3.6 [3.1, 3.9] L/min/m 2 vs 2.6 [2.5, 3.2] L/min/m 2 , p = 0.03) and cardiac power index (0.61 [0.55, 0.70] W/m 2 vs 0.53 [0.44, 0.57] W/m 2 , p = 0.03) compared to the control group at 48-96 hours after randomization. There were no statistically significant differences between the two groups for other collected hemodynamic variables. Conclusions: TH is a safe adjunct therapy for patients presenting with CS and may yield improvement in specific hemodynamic parameters. Larger studies are necessary to better understand the clinical benefits of TH in patients presenting with CS.
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