Remote Ischemic Conditioning in Abdominal Surgery
Status unconfirmed · Not applicable
Conditions studied: Laparotomy, Laparoscopy, Retroperitoneal Disease, Pelvis Disease, Pancreatic Diseases, Liver Diseases, Gastrointestinal Disease, Urologic Diseases, Complication of Surgical Procedure
In brief
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.
Key facts
- Study ID
- NCT03234543
- Run by
- Rutgers, The State University of New Jersey
- People needed
- 100
- Starts
- 2017-10-08
- Expected to finish
- 2020-06-15
- Last updated by the study team
- 2019-02-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Subjects with lower extremity paralysis
- Lower extremity amputees
- Known, documented peripheral arterial disease
- Body mass index > 45
- Pregnancy
- Trauma patients
- Organ transplant recipients
- Prior major surgery during current hospitalization (for instance, a patient undergoing re-laparotomy for a complication from a previous procedure)
- Patient taking sulfonylureas or nitrates prior to or during admission (listed in Appendix B)
- a. These subjects are excluded because sulfonylureas are shown to abrogate the RIC effect whereas nitrates are shown to mimic the RIC effect in animal models.
- Non-elective surgeries (urgent or emergent surgeries)
- General surgical procedures with no planned intra-abdominal component
Where it is running
- University Hospital — Newark, New Jersey, United States
Full record on ClinicalTrials.gov
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