Status:
WITHDRAWN
Therapeutic Hypothermia for Severe Acute Pancreatitis
Lead Sponsor:
NYU Langone Health
Conditions:
Pancreatitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Background: Acute pancreatitis is characterized by a high mortality rate (10%-15%), and a remarkably unpredictable clinical course. Approximately 50% of deaths in acute pancreatitis occur early-within...
Eligibility Criteria
Inclusion
- Aged 18 to 80
- Intubation with mechanical ventilatory support as medically necessary
- 2\) Cooling device or technique available for \>36 hours 3) Core temperature ≥36°C 4) SAP either by:
- Ranson Score of \> 7
- CT with pancreatic necrosis greater than 50%
- Significant deterioration of clinical status-dysfunction of 2 or more organ systems (defined by ACCP/SCCM Organ Failure guidelines Chest 2009) 5) ICU monitoring medically necessary
Exclusion
- Patient already receiving therapeutic hypothermia treatment
- Unlikely to survive for the next 24 hours in the opinion of the ICU Consultant or Surgical Consultant treating the patient
- Temperature ≤34°C at hospital admission
- Pregnancy (all female patients of child bearing age who meet the inclusion criteria will undergo a urine pregnancy test).
- History of Cryoglobulinemia
- No need for ICU monitoring
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01794858
Start Date
June 1 2012
End Date
July 1 2013
Last Update
March 11 2016
Active Locations (1)
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1
NYU Medical Center
New York, New York, United States, 10016