Inflammatory Response During Anesthesia and Surgery

Myocardial Ischemia Clinical Trial

— IRAS  

Official title:

A Prospective, Randomized Trial to Study the Effects of Different Anesthetic Agents on the Perioperative Immune Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356746
• Other study ID #: METC-05/261-E
• Status: Completed
• Phase: N/A
• First received: July 24, 2006
• Last updated: June 23, 2015
• Start date: March 2006
• Est. completion date: March 2009

Study information

• Verified date: June 2008
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate the effects of total intravenous anesthesia versus volatile anesthesia on the perioperative inflammatory response during and after major surgery.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2009
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 18 years and planned for elective Coronary Artery Bypass Grafting (CABG), aorta surgery or Implantable Cardioverter Defibrillator (ICD) replacement

Exclusion Criteria:

• Emergency operations

• Patients undergoing combined or re-do procedures

• Patients who are diagnosed with or undergoing treatment for a steroid or hormone disorder, excluding diabetes

• Patients suffering from chronic inflammatory diseases

• Patients suffering form current infections

• Patients currently treated with steroids

• Patients undergoing treatment or care for a malignancy

• Patients participating in another study that may interfere with the endpoints of the IRAS trial

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Myocardial Ischemia
• Systemic Inflammatory Response Syndrome

Locations

Country	Name	City	State
Netherlands	UMC Utrecht, Division of Perioperative Care and Emergency Medicine, Department of Anesthesiology	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	European Association of Cardiothoracic Anaesthesiologists

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

de Kleijn D, Pasterkamp G. Toll-like receptors in cardiovascular diseases. Cardiovasc Res. 2003 Oct 15;60(1):58-67. Review. — View Citation

de Rossi LW, Brueckmann M, Rex S, Barderschneider M, Buhre W, Rossaint R. Xenon and isoflurane differentially modulate lipopolysaccharide-induced activation of the nuclear transcription factor KB and production of tumor necrosis factor-alpha and interleukin-6 in monocytes. Anesth Analg. 2004 Apr;98(4):1007-12, table of contents. — View Citation

Larsen B, Hoff G, Wilhelm W, Buchinger H, Wanner GA, Bauer M. Effect of intravenous anesthetics on spontaneous and endotoxin-stimulated cytokine response in cultured human whole blood. Anesthesiology. 1998 Nov;89(5):1218-27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative inflammatory response through measurement of expression and responsiveness of Toll-like Receptor (TLR) 2 and 4 of monocytes from full blood samples.		72 hours	No
Secondary	Parameters of systemic haemodynamics		72 hours	No
Secondary	Need of vasoactive medication to develop predefined haemodynamic goals		72 hours	No
Secondary	Biochemical parameter of myocardial ischaemia and infarction (Troponin-I), measured immediately before and after surgery, 24 hr and 72hr after surgery		72 hours	No
Secondary	Serious adverse events assessed 3 days after surgery, at discharge, 30 days and one year after surgery		1 year	No