Inflammatory Response During Anesthesia and Surgery (IRAS)
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|ClinicalTrials.gov Identifier: NCT00356746|
Recruitment Status : Completed
First Posted : July 26, 2006
Last Update Posted : June 24, 2015
|Condition or disease|
|Systemic Inflammatory Response Syndrome Myocardial Ischemia|
Patients undergoing major surgical procedures, in particular those undergoing cardiac surgery, develop a severe inflammatory response in up to 50% of cases leading to increased mortality and morbidity. The inflammatory response depends on the surgical procedure and on patient related factors like genetic predisposition and co morbidities. However, in vitro studies showed that the type and duration of general anaesthesia also influences the extent of perioperative inflammation.
Comparison: total intravenous anesthesia by propofol is compared to volatile anesthesia by isoflurane with respect to development of perioperative inflammatory response.
The IRAS study is a single centre study, executed in the University Medical Centre Utrecht, The Netherlands. Four different patient groups are included. 1) Patients undergoing coronary artery bypass grafting (CABG) with use of cardiopulmonary bypass (CPB), 2) patients undergoing aorta aneurysm repair via endovascular approach and 3) via conventional open procedure, and 4) patients undergoing surgery for replacement of implantable cardioverter defibrillator (ICD).
The IRAS is a prospective, randomized clinical trial. Patients are randomly assigned to a intravenous or a balanced anaesthesia technique. Peripheral blood samples are drawn before, during and up to 72h after surgery.
|Study Type :||Observational|
|Actual Enrollment :||120 participants|
|Official Title:||A Prospective, Randomized Trial to Study the Effects of Different Anesthetic Agents on the Perioperative Immune Response|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||March 2009|
elective CABG only patients
elective ICD replacement surgical patients requiring general anesthesia
- Perioperative inflammatory response through measurement of expression and responsiveness of Toll-like Receptor (TLR) 2 and 4 of monocytes from full blood samples. [ Time Frame: 72 hours ]
- Parameters of systemic haemodynamics [ Time Frame: 72 hours ]
- Need of vasoactive medication to develop predefined haemodynamic goals [ Time Frame: 72 hours ]
- Biochemical parameter of myocardial ischaemia and infarction (Troponin-I), measured immediately before and after surgery, 24 hr and 72hr after surgery [ Time Frame: 72 hours ]
- Serious adverse events assessed 3 days after surgery, at discharge, 30 days and one year after surgery [ Time Frame: 1 year ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356746
|UMC Utrecht, Division of Perioperative Care and Emergency Medicine, Department of Anesthesiology|
|Utrecht, Netherlands, 3508 GA|
|Study Chair:||Cor J Kalkman, Prof MD PhD||University Medical Centre Utrecht, The Netherlands|
|Study Director:||Wolfgang F Buhre, MD PhD||University Medical Centre Utrecht, The Netherlands|
|Study Director:||Gerard Pasterkamp, Prof MD PhD||University Medical Centre Utrecht, The Netherlands|