To determine whether perioperative myocardial ischemia is associated with adverse outcome in patients scheduled for major abdominal surgery.
ID
Source
Brief title
Condition
- Myocardial disorders
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Perioperative myocardial ischemia characterized by positive high sensitive
cardiac troponin T tests at day 0, 1, 3, 7.
To rule out an increase in troponin T due to inflammation an IL-6 and TNF-A
determination will be performed in in all samples.
Secondary outcome
Fatal and nonfatal postoperative complications: death, wound infection, sepsis,
CVA/TIA, heart failure, AF, anastomotic dehiscence, respiratory insufficiency
during 30 days after the surgical procedure.
Background summary
Annually, approximately 4% of the Dutch population is scheduled for major
noncardiac surgery. One third of which are abdominal surgical patients.
Abdominal surgery is considered to be intermediate risk surgery, with an
overall preoperative mortality rate of 2 to 3%. However, a recent Dutch cohort
study of 3,6 million surgical patients identified several high risk abdominal
procedures with mortality rates >5%: intestinal, gastric, esophageal,
pancreatic and liver surgery. To understand why these procedures are associated
with such high preoperative mortality better understanding of the pathogenesis
of postoperative morbidity and mortality in abdominal surgical patients is
needed.
Perioperative myocardial ischemia (PMI) is a common complication of major non
cardiac surgery. However, the vast majority of ischemic events remain unnoticed
due to masking by the residual effects of anesthetics and sedatives or
treatment with potent postoperative analgetics. The pathofysiological
mechanisms underlying PMI are not completely clear, but seem associated with
the extend of coronary artery disease. In selected patient populations at
increased risk of coronary artery disease undergoing higher risk surgery the
reported incidence of PMI exceeded 10 to 20%. Patients undergoing major
abdominal surgery are at risk of postoperative complications, such as
anastomotic dehiscence, wound infection, respiratory insufficiency, sepsis and
death. The effect of perioperative myocardial ischemia on postoperative outcome
in these patients remains unclear.
Study objective
To determine whether perioperative myocardial ischemia is associated with
adverse outcome in patients scheduled for major abdominal surgery.
Study design
Observational study.
Study burden and risks
Three postoperative venous punctions, which will be planned together with
regular postoperative blood withdrawals, and an interview by telephone at 30
days after surgery.
Koekoekslaan 1
Nieuwegein 3430 EM
NL
Koekoekslaan 1
Nieuwegein 3430 EM
NL
Listed location countries
Age
Inclusion criteria
Patients > 45 years of age with 1 or more major cardiovascular risk factors: Congestive heart failure, peripheral artery disease (intermittent claudication, history of vascular surgery etc), diabetes mellitus type I or II, coronary artery disease (history of myocardial infarction, stable angina pectoris, history of ischemia or coronary artery disease on cardiac tests (ECG, scintigraphy, echocardiogram, coronairangiogram etc), CVA, renal insufficiency (creat > 150umol/l), aortic valve stenosis (valve area < 1 cm2) OR 2 or more minor cardiovascular risk factors: Age > 70, hypertension, high cholesterol, low functional capacity (4 METs or less), TIA, COPD AND undergoing abdominal surgery with an expected 30-day mortality rate > 2-3%: colorectal, gastric, pancreatic and liver surgery.
Exclusion criteria
Age < 45 years of age, not scheduled for higher risk abdominal surgery, low cardiovasacular risk profile.
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 | NL39172.100.11 |