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      Pilot Feasibility Study of Therapeutic Hypothermia for Moderate to Severe Acute Respiratory Distress Syndrome

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          Abstract

          Objectives

          Prior studies suggest hypothermia may be beneficial in ARDS, but cooling causes shivering and increases metabolism. The objective of this study was to assess the feasibility of performing a randomized clinical trial (RCT) of hypothermia in patients with ARDS receiving treatment with neuromuscular blockade (NMB) because they cannot shiver.

          Design

          Retrospective study and pilot prospective open-label feasibility study.

          Setting

          Medical Intensive Care Unit.

          Patients

          Retrospective review of 58 patients with ARDS based on Berlin criteria and P aO2:FiO2 (P:F)<150 who received NMB. Prospective hypothermia treatment in 8 ARDS patients with (P:F)<150 receiving NMB.

          Intervention

          Cooling to 34°–36°C for 48h.

          Measurements and Main Results

          Core temperature, hemodynamics, serum glucose and electrolytes, and P:F, were sequentially measured and medians (interquartile ranges) presented, and 28-day ventilator-free days (VFDs), and hospital mortaltiy were calculated in historical controls and 8 cooled patients. Average patient core temperature was 36.7(36–37.3)°C and fever occurred during NMB in 30/58 retrospective patients. In the prospectively cooled patients core temperature reached target range ≤4h of initiating cooling, remained <36°C for 92% of the 48h cooling period without adverse events, and was lower than the controls (34.35(34–34.8)°C; p<0.0001). Compared with historical controls, the cooled patients tended to have lower hospital mortality (75% vs 53.4%; p=0.26), more VFDs (9(0–21.5) vs. 0(0–12); p=0.16) and higher day-3 P:F (255(160–270) vs. 171(120–214), p=0.024).

          Conclusions

          NMB alone does not cause hypothermia, but allowed ARDS patients to be effectively cooled. Results support conducting an RCT of hypothermia in ARDS and the feasibility of studying ARDS patients receiving NMB.

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          Author and article information

          Journal
          0355501
          3206
          Crit Care Med
          Crit. Care Med.
          Critical care medicine
          0090-3493
          1530-0293
          18 January 2017
          July 2017
          01 July 2018
          : 45
          : 7
          : 1152-1159
          Affiliations
          [1 ]Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Maryland School of Medicine, Baltimore, MD 21201
          [2 ]Program in Trauma, Department of Surgery, University of Maryland School of Medicine, Baltimore, MD 21201
          [3 ]Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, MD 21201
          [4 ]Medicine and Research Services, Baltimore Veterans Affairs Medical Care System; Baltimore, MD 21201
          Author notes
          Corresponding author: Jeffrey D. Hasday, M.D., University of Maryland School of Medicine, Health Science Facility-II, Rm. S347, 20 Penn St. Baltimore, MD 21201, Phone: 410-706-5507, FAX: 410-706-5502, jhasday@ 123456umaryland.edu
          Article
          PMC5474188 PMC5474188 5474188 nihpa843231
          10.1097/CCM.0000000000002338
          5474188
          28406814
          Categories
          Article

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