Systemic Inflammatory Response SyndromeIRASNCT00356746
Inflammatory Response During Anesthesia and Surgery
An observational study of Systemic Inflammatory Response Syndrome and Myocardial Ischemia, run by UMC Utrecht at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Inflammatory Response Syndrome, Myocardial Ischemia
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2006to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: specific surgical patients receiving general anesthesia of university teaching hospital
Who may be able to join
- Patients older than 18 years and planned for elective Coronary Artery Bypass Grafting (CABG), aorta surgery or Implantable Cardioverter Defibrillator (ICD) replacement
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
UMC Utrecht, Division of Perioperative Care and Emergency Medicine, Department of Anesthesiology
Utrecht, 3508 GA
About this study
Official title: A Prospective, Randomized Trial to Study the Effects of Different Anesthetic Agents on the Perioperative Immune Response
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.
Read the 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.
- Keywords
- Perioperative inflammatory response, General anesthesia, Toll-Like Receptors
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | elective CABG only patients | |
| 2 | elective ICD replacement surgical patients requiring general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative inflammatory response through measurement of expression and responsiveness of Toll-like Receptor (TLR) 2 and 4 of monocytes from full blood samples.
Measured: 72 hours
Secondary outcomes (4)
Parameters of systemic haemodynamics
Measured: 72 hours
Need of vasoactive medication to develop predefined haemodynamic goals
Measured: 72 hours
Biochemical parameter of myocardial ischaemia and infarction (Troponin-I), measured immediately before and after surgery, 24 hr and 72hr after surgery
Measured: 72 hours
Serious adverse events assessed 3 days after surgery, at discharge, 30 days and one year after surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2007
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Systemic Inflammatory Response SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- European Association of Cardiothoracic Anaesthesiologists
- Investigators
- Cor J Kalkman, Prof MD PhD, Study chair, University Medical Centre Utrecht, The NetherlandsWolfgang F Buhre, MD PhD, Study director, University Medical Centre Utrecht, The NetherlandsGerard Pasterkamp, Prof MD PhD, Study director, University Medical Centre Utrecht, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356746
- Sponsor's protocol ID
- METC-05/261-E
- Acronym
- IRAS
- Status last verified
- Jun 2008
- First submitted
- 24 Jul 2006
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
de Kleijn D, Pasterkamp G. Toll-like receptors in cardiovascular diseases. Cardiovasc Res. 2003 Oct 15;60(1):58-67. doi: 10.1016/s0008-6363(03)00348-1.
PubMed 14522407de 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):1007-1012. doi: 10.1213/01.ANE.0000106860.27791.44.
PubMed 15041589Larsen 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. doi: 10.1097/00000542-199811000-00023.
PubMed 9822011Flier S, Concepcion AN, Versteeg D, Kappen TH, Hoefer IE, de Lange DW, Pasterkamp G, Buhre WF. Monocyte hyporesponsiveness and Toll-like receptor expression profiles in coronary artery bypass grafting and its clinical implications for postoperative inflammatory response and pneumonia: An observational cohort study. Eur J Anaesthesiol. 2015 Mar;32(3):177-88. doi: 10.1097/EJA.0000000000000184.
PubMed 25405275Flier S, Post J, Concepcion AN, Kappen TH, Kalkman CJ, Buhre WF. Influence of propofol-opioid vs isoflurane-opioid anaesthesia on postoperative troponin release in patients undergoing coronary artery bypass grafting. Br J Anaesth. 2010 Aug;105(2):122-30. doi: 10.1093/bja/aeq111. Epub 2010 Jun 23.
PubMed 20573633
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial to Study the Effects of Different Anesthetic Agents on the Perioperative Immune Response
- ClinicalTrials.gov ID
- NCT00356746
- Acronym / sponsor ID
- IRAS / METC-05/261-E
- Keywords
- Perioperative inflammatory response, General anesthesia, Toll-Like Receptors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- European Association of Cardiothoracic Anaesthesiologists
- Study start
- Mar 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 26 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –elective CABG only patients |
| 2 | – | –elective ICD replacement surgical patients requiring general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- specific surgical patients receiving general anesthesia of university teaching hospital
Key inclusion criteria (1 listed)
- Patients older than 18 years and planned for elective Coronary Artery Bypass Grafting (CABG), aorta surgery or Implantable Cardioverter Defibrillator (ICD) replacement
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Background: PubMed 14522407de Kleijn D, Pasterkamp G. Toll-like receptors in cardiovascular diseases. Cardiovasc Res. 2003 Oct 15;60(1):58-67. doi: 10.1016/s0008-6363(03)00348-1.
- Background: PubMed 15041589de 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):1007-1012. doi: 10.1213/01.ANE.0000106860.27791.44.
- Background: PubMed 9822011Larsen 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. doi: 10.1097/00000542-199811000-00023.
- Derived from this study: PubMed 25405275Flier S, Concepcion AN, Versteeg D, Kappen TH, Hoefer IE, de Lange DW, Pasterkamp G, Buhre WF. Monocyte hyporesponsiveness and Toll-like receptor expression profiles in coronary artery bypass grafting and its clinical implications for postoperative inflammatory response and pneumonia: An observational cohort study. Eur J Anaesthesiol. 2015 Mar;32(3):177-88. doi: 10.1097/EJA.0000000000000184.
- Derived from this study: PubMed 20573633Flier S, Post J, Concepcion AN, Kappen TH, Kalkman CJ, Buhre WF. Influence of propofol-opioid vs isoflurane-opioid anaesthesia on postoperative troponin release in patients undergoing coronary artery bypass grafting. Br J Anaesth. 2010 Aug;105(2):122-30. doi: 10.1093/bja/aeq111. Epub 2010 Jun 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cor J Kalkman, Prof MD PhD study chair
University Medical Centre Utrecht, The Netherlands
Wolfgang F Buhre, MD PhD study director
University Medical Centre Utrecht, The Netherlands
Gerard Pasterkamp, Prof MD PhD study director
University Medical Centre Utrecht, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Inflammatory Response Syndrome and Myocardial Ischemia, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00356746, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015.