Inflammatory Response During Anesthesia and Surgery (IRAS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by UMC Utrecht.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
European Association of Cardiothoracic Anaesthesiologists
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00356746
First received: July 24, 2006
Last updated: June 3, 2008
Last verified: June 2008
  Purpose

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.


Condition
Systemic Inflammatory Response Syndrome
Myocardial Ischemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Randomized Trial to Study the Effects of Different Anesthetic Agents on the Perioperative Immune Response

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Assessment of perioperative inflammatory response through measurement of expression of TLR-2 and 4 on monocytes and via in vitro assessment of responsiveness of immune system to exogenous ligands by measuring resulting cytokines in full blood samples [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parameters of systemic haemodynamics [ Designated as safety issue: No ]
  • Need of vasoactive medication to develop predefined haemodynamic goals [ Designated as safety issue: No ]
  • Biochemical parameter of myocardial ischaemia and infarction (Troponine-I), measured immediately before and after surgery, 24 hr and 72hr after surgery [ Designated as safety issue: No ]
  • Serious adverse events assessed 3 days after surgery, at discharge, 30 days and one year after surgery [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: March 2006
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
elective CABG patients
2
elective ICD replacement surgical patients
3
elective endovascular aorta repair patients
4
elective conventional abdominal aorta aneurysm surgical patients

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

specific surgical patients receiving general anesthesia of university teaching hospital

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356746

Locations
Netherlands
UMC Utrecht, Division of Perioperative Care and Emergency Medicine, Department of Anesthesiology
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
European Association of Cardiothoracic Anaesthesiologists
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: WF Buhre, UMC Utrecht, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT00356746     History of Changes
Other Study ID Numbers: METC-05/261-E
Study First Received: July 24, 2006
Last Updated: June 3, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Perioperative inflammatory response
General anesthesia
Toll-Like Receptors

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Systemic Inflammatory Response Syndrome
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Inflammation
Shock
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014