Remote Ischemic Conditioning in Abdominal Surgery (NCT03234543) | Clinical Trial Compass
UnknownNot Applicable
Remote Ischemic Conditioning in Abdominal Surgery
United States100 participantsStarted 2017-10-08
Plain-language summary
This phase II randomized (1:1) controlled trial will examine the effects of remote ischemic conditioning (RIC) on the outcomes of major abdominal surgery. One hundred subjects will be enrolled at a single institution - University Hospital - Newark. The study population are patients undergoing major abdominal surgery (anticipated to be \>/= 2 hrs long with a hospital stay \>/= 2 days). Subjects in the treatment group will receive lower limb ischemic conditioning at 3 different time points: before surgery, POD 1 and POD 2. The primary outcome is the 30-day comprehensive complications index (CCI). Key secondary outcomes are changes in systemic inflammatory markers in peripheral blood and 30-day mortality.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adults (\> 18 years of age)
✓. Both genders
✓. Undergoing major abdominal surgery as above
✓. Elective surgeries
✓. Both outpatients and in-hospital patients
✓. Post-op length of stay expected to be at least 2 days by the primary surgical service
✕. Prior major surgery during current hospitalization (for instance, a patient undergoing re-laparotomy for a complication from a previous procedure)