A Study to Assess Therapeutic Hypothermia to Cool Injured Legs in Patients with Acute Respiratory Distress Syndrome

Overview

About this study

The primary purpose of this study is to evaluate whether early treatment with therapeutic hypothermia (TH), along with neuromuscular blockade (NMB) to prevent shivering, will be beneficial to patients with Acute Respiratory Distress Syndrome (ARDS).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • All patients between the ages of 18 and 65 years old.
  • Endotracheal tube or tracheostomy in place and mechanically ventilated for ≤ 7 days.
  • Admitted to a participating ICU.
  • Radiologic evidence of bilateral pulmonary infiltrates not fully explained by pleural  effusions, atelectasis, or hydrostatic pulmonary edema  
  • P/F ratio < 200 with PEEP ≥ 8 cm H2O; If ABG values are not available, the P/F ratio may be inferred from SpO2 values as long as following conditions are met:  
    • SpO2 values are 80-96%;
    • SpO2 is measured ≥10 min after any change in FIO2;  
    • PEEP is ≥ 8 cm H2O;
    • The pulse oximeter waveform tracing is adequate;
    • The qualifying inferred P/F ratio is confirmed 1-6h after initial determination.
  • Access to an LAR to provide consent.  
  • Criteria 3 AND 4 must be met within 48h of enrollment and randomization, not be fully  explained by hydrostatic pulmonary edema, and must have occurred within 7 days onset  of a condition associated with ARDS.
  • Patients may be enrolled and decision about randomization delayed if all criteria other than P/F ratio < 200 are met and then randomized if and when the P/F ratio < 200 (as long as this occurs within 48h of randomization).

Exclusion Criteria:

  • Missed ARDS window (> 48hrs).  
  • Missed NMB window: (> 12 hrs).
  • Missed mechanical ventilation window (> 7 days).
  • Refractory hypotension (> 0.2 mcg/kg/min of norepinephrine or equivalent dose for 6 h or longer).
  • Core temperature < 35.5°C while not receiving CRRT.
  • Patient is unable to give consent and no Legally authorized representative is available.
  • Significant, active bleeding (>3u blood products and/or surgical/IR intervention).  
  • Platelets <10K/mm^3 (uncorrected).
  • Active hematologic malignancy.  
  • Skin process that precludes cooling device.  
  • Moribund, not likelyto survive 72 hours.  
  • Pre-morbid condition makes it unlikely that patient will survive 28 days.  
  • Do Not Resuscitate status. 
  • Not likely to remain intubated for ≥ 48h.  
  • Physician of record unwilling to participate.  
  • Severe underlying lung disease:  
    • On home O2;
    • On BIPAP (except for OSA);  
    • Prior lung transplantation.
  • Pregnant.
  • BMI > 50 kg/m2.  
  • Known NYHA class IV heart disease.  
  • Acute Coronary Syndrome past 30 days (MI, unstable angina).  
  • Cardiac arrest within 30 days of enrollment.  
  • Burns over > 20% of the body surface.  
  • Severe chronic liver disease (Child-Pugh score 12-15).  
  • Previously randomized in CHILL study.

 

 

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Lioudmila Karnatovskaia, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20522390

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