Status:
UNKNOWN
Remote Ischemic Conditioning in Abdominal Surgery
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
Laparotomy
Laparoscopy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 si...
Detailed Description
STUDY GOALS AND OBJECTIVES: 1. To obtain preliminary data regarding postoperative complications in subjects undergoing abdominal surgery and receiving remote limb ischemic or sham conditioning. 2. To...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03234543
Start Date
October 8 2017
End Date
June 15 2020
Last Update
February 25 2019
Active Locations (1)
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1
University Hospital
Newark, New Jersey, United States, 07101