Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT01794858
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18 to 80
2. 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 Criteria:
1. Patient already receiving therapeutic hypothermia treatment
2. Unlikely to survive for the next 24 hours in the opinion of the ICU Consultant or Surgical Consultant treating the patient
3. Temperature ≤34°C at hospital admission
4. Pregnancy (all female patients of child bearing age who meet the inclusion criteria will undergo a urine pregnancy test).
5. History of Cryoglobulinemia
6. No need for ICU monitoring
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01794858
Study Brief:
Protocol Section:
NCT01794858