To determine the effect of RIPC on MINS in patients after pancreatic sugery.
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Maximum postoperative concentration of high-sensitive cardiac troponin T.
Secondary outcome
Markers of inflammatory, intestinal and renal injury, postoperative
complicatons during 30 days, length of stay and hospital mortality.
Background summary
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.
Study objective
To determine the effect of RIPC on MINS in patients after pancreatic sugery.
Study design
Randomised controlled parallel group mono-center pilot study.
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.
Study burden and risks
After routine anesthesia screening at the outpatient anesthesia clinic,
patients proceed with standard surgical care. Urine samples and blood samples
ar collected during the first 48 hours after surgery using an arterial line
(rourine care) and urinary catheter (routine care). RIPC or control
intervention is performed after induction of anesthesia and does not influence
total duration of surgery. RIPC is a simple manoevre without known risk for the
patient.
Koekoekslaan 1
Nieuwegein 3430 EM
NL
Koekoekslaan 1
Nieuwegein 3430 EM
NL
Listed location countries
Age
Inclusion criteria
Age 18 years or older
Scheduled for pancreaticoduodenectomy
Exclusion criteria
Pregnancy
No informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57818.100.16 |