Myocardial Ischemia Clinical Trial
Official title:
The Effect of Remote Ischemic Preconditioning on Postoperative Myocardial Ischemia in Pancreatic Surgery: a Randomized Controlled Trial
High-risk abdominal surgery is frequently complicated by postoperative complications, such as
sepsis, pneumonia or anastomotic dehiscence. Asymptomatic myocardial injury after abdominal
surgery (MINS) predicts non-cardiac complications. The etiology of MINS in abdominal surgery
patients is unknown. Remote ischemic preconditioning (RIPC) is a physiologic mechanism that
exposes tissues to brief periods of non-lethal ischemia and reperfusion, creating resistence
for future serious ischemic insults. RIPC in patients after cardiac or aortic surgery is
associated with a protective effect on the heart. The effect of RIPC in abdominal surgery
patients is unknown.
Objective of the study: To determine the effect of RIPC on MINS in patients after pancreatic
sugery.
Study design: Randomised controlled parallel group mono-center pilot study.
Study population: 90 adult patients scheduled for elective pancreaticoduodenectomy in St.
Antonius Hospital (45 in the intervention group and 45 in the control group).
Intervention: RIPC: 3 periods of 5 minutes of ischemia followed by 5 minutes of reperfusion
are created by inflating a blood pressure cuff on the upper extremity after induction of
anesthesia and prior to surgery. In the control group a non-inflated blood pressure cuff is
placed on the upper extremity for 30 minutes.
Primary study parameters/outcome of the study: Maximum postoperative concentration of
high-sensitive cardiac troponin T.
Secondary study parameters/outcome of the study: Markers of inflammatory, intestinal and
renal injury, postoperative complications during 30 days, length of stay and hospital
mortality.
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