Coronary Artery DiseasePhase 4NCT00415701
Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery
A Phase 4 study testing Etomidate, Propofol and Hydrocortisone in people with Coronary Artery Disease and Mitral Valve Regurgitation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The purpose of this study is to evaluate the effect of a single dose of etomidate for patients undergoing cardiac surgery with the use of cardiopulmonary bypass (CPB) on post-CPB adrenocortical responsiveness, on requirements of hemodynamic support, and on use of intensive care resources. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Mitral Valve Regurgitation
- What is being tested?
- Etomidate, Propofol and Hydrocortisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2006to Dec 2009
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients undergoing elective
- coronary artery bypass graft (primary or re-operation)
- mitral valve reconstruction/replacement for mitral valve regurgitation
- Age between 18 and 80 years (extremes included)
- Subject itself has signed the informed consent
- No clinically relevant deviation from the laboratory's reference range of biochemistry, hematology, or urinalysis testing
Who cannot join
- Participation in another ongoing interventional trial
- Known adrenocortical insufficiency
- Use of etomidate or propofol within 1 week preoperatively
- Use of glucocorticoids within 6 month preoperatively
- Known sensitivity to etomidate, propofol, or emulgator
- Severe hepatic dysfunction (bilirubin > 3mg/dl)
Show all 16Show fewer
- Severe renal dysfunction (plasma creatinine > 180mikromol/l)
- Sepsis, endocarditis or other chronic inflammatory disease
- Manifest insulin-dependent diabetes mellitus
- Positive HIV serology
- Hemodynamically significant carotid stenosis requiring treatment
- Serious illnesses: endocrine, neurological, psychiatric, metabolic disturbances
- Pregnancy or breast-feeding female; females will be subject to pregnancy testing
- Requirement of rapid sequence induction
- Emergency surgery
- History of asthma
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Departments of Intensive Care Medicine and Anesthesiology
Bern, Canton of Bern, 3010
About this study
Official title: Effect of an Anesthetic Induction Dose of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery
The purpose of this study is to evaluate the effect of a single dose of etomidate for patients undergoing cardiac surgery with the use of cardiopulmonary bypass (CPB) on post-CPB adrenocortical responsiveness, on requirements of hemodynamic support, and on use of intensive care resources.
- Being tested
- Etomidate, Propofol, Hydrocortisone, NaCl 0.9%, Tetracosactin
- Keywords
- Etomidate, Propofol, Adrenocortical Insufficiency, Hemodynamic Process, Vasoactive Agonists, Coronary Artery Bypass, Ischemic Coronary Heart Disease, Mitral valve reconstruction/replacement, Mitral valve regurgitation, Heart Valve Prosthesis, Cardiopulmonary Bypass
- Medical subject headings
- Coronary Artery Disease, Mitral Valve Insufficiency, Addison Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtomidateDrug
Single induction dose of etomidate 0.2%; total dose 0.15 mg/kg
PropofolDrug
Single induction dose of propofol 2%; total dose 1.5 mg/kg
HydrocortisoneDrug
Hydrocortisone 100 mg/2 ml: day of operation 3x, POD 1 2x, POD 2 1x
NaCl 0.9%Drug
NaCl 0.9% 2 ml; day of operation 3x, POD 1 2x, POD 2 1x
TetracosactinOther
Diagnostic test, Tetracosactin 250 microg iv
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Etomidate as a single induction dose Receives: Drug: Etomidate |
| 2 | Active comparator | Propofol as a single induction dose Receives: Drug: Propofol |
| 3 | Other | Hydrocortisone substitution or placebo (50-50%) in etomidate-group Receives: Drug: Hydrocortisone; Drug: NaCl 0.9%; Other: Tetracosactin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of absolute and relative adrenal insufficiency
Measured: Preoperative day to postoperative day (POD) 4
Cumulative requirements of vasoactive drugs during surgery and in the intensive care unit (ICU)
Measured: Induction of anesthesia to POD 2
Secondary outcomes (5)
Incidence of failure to wean off cardiopulmonary bypass on first intention
Measured: intraoperatively
Serum lactate
Measured: Induction of anesthesia to discharge ICU
Time to extubation
Measured: Induction of anesthesia to extubation
Length of stay (LOS) in the intensive care unit (ICU), intermediate care unit (IMC), and hospital
Measured: Admission to discharge: ICU, IMC, and hospital
Association of results with preoperative risk, stress-dose hydrocortisone replacement, type of surgery
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Stephan M Jakob, Professor, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415701
- Sponsor's protocol ID
- DINA-KEK7406-IBAN-2006-1
- Status last verified
- Mar 2010
- First submitted
- 22 Dec 2006
- Last updated
- 4 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Malerba G, Romano-Girard F, Cravoisy A, Dousset B, Nace L, Levy B, Bollaert PE. Risk factors of relative adrenocortical deficiency in intensive care patients needing mechanical ventilation. Intensive Care Med. 2005 Mar;31(3):388-92. doi: 10.1007/s00134-004-2550-8. Epub 2005 Feb 10.
PubMed 15703896Weis F, Kilger E, Roozendaal B, de Quervain DJ, Lamm P, Schmidt M, Schmolz M, Briegel J, Schelling G. Stress doses of hydrocortisone reduce chronic stress symptoms and improve health-related quality of life in high-risk patients after cardiac surgery: a randomized study. J Thorac Cardiovasc Surg. 2006 Feb;131(2):277-82. doi: 10.1016/j.jtcvs.2005.07.063.
PubMed 16434254den Brinker M, Joosten KF, Liem O, de Jong FH, Hop WC, Hazelzet JA, van Dijk M, Hokken-Koelega AC. Adrenal insufficiency in meningococcal sepsis: bioavailable cortisol levels and impact of interleukin-6 levels and intubation with etomidate on adrenal function and mortality. J Clin Endocrinol Metab. 2005 Sep;90(9):5110-7. doi: 10.1210/jc.2005-1107. Epub 2005 Jun 28.
PubMed 15985474Absalom A, Pledger D, Kong A. Adrenocortical function in critically ill patients 24 h after a single dose of etomidate. Anaesthesia. 1999 Sep;54(9):861-7. doi: 10.1046/j.1365-2044.1999.01003.x.
PubMed 10460557Annane D. ICU physicians should abandon the use of etomidate! Intensive Care Med. 2005 Mar;31(3):325-6. doi: 10.1007/s00134-005-2560-1. Epub 2005 Jan 27. No abstract available.
PubMed 15750800Duthie DJ, Fraser R, Nimmo WS. Effect of induction of anaesthesia with etomidate on corticosteroid synthesis in man. Br J Anaesth. 1985 Feb;57(2):156-9. doi: 10.1093/bja/57.2.156.
PubMed 2982387Fellows IW, Bastow MD, Byrne AJ, Allison SP. Adrenocortical suppression in multiply injured patients: a complication of etomidate treatment. Br Med J (Clin Res Ed). 1983 Dec 17;287(6408):1835-7. doi: 10.1136/bmj.287.6408.1835.
PubMed 6322902Fellows IW, Byrne AJ, Allison SP. Adrenocortical suppression with etomidate. Lancet. 1983 Jul 2;2(8340):54-5. doi: 10.1016/s0140-6736(83)90043-0. No abstract available.
PubMed 6134923Wagner RL, White PF, Kan PB, Rosenthal MH, Feldman D. Inhibition of adrenal steroidogenesis by the anesthetic etomidate. N Engl J Med. 1984 May 31;310(22):1415-21. doi: 10.1056/NEJM198405313102202.
PubMed 6325910Allolio B, Stuttmann R, Fischer H, Leonhard W, Winkelmann W. Long-term etomidate and adrenocortical suppression. Lancet. 1983 Sep 10;2(8350):626. doi: 10.1016/s0140-6736(83)90710-9. No abstract available.
PubMed 6136774Crozier TA, Beck D, Wuttke W, Kettler D. [Relation of the inhibition of cortisol synthesis in vivo to plasma etomidate concentrations]. Anaesthesist. 1988 May;37(5):337-9. German.
PubMed 3261141Watt I, Ledingham IM. Mortality amongst multiple trauma patients admitted to an intensive therapy unit. Anaesthesia. 1984 Oct;39(10):973-81. doi: 10.1111/j.1365-2044.1984.tb08885.x.
PubMed 6496912Kenyon CJ, McNeil LM, Fraser R. Comparison of the effects of etomidate, thiopentone and propofol on cortisol synthesis. Br J Anaesth. 1985 May;57(5):509-11. doi: 10.1093/bja/57.5.509.
PubMed 2986663Kilger E, Weis F, Briegel J, Frey L, Goetz AE, Reuter D, Nagy A, Schuetz A, Lamm P, Knoll A, Peter K. Stress doses of hydrocortisone reduce severe systemic inflammatory response syndrome and improve early outcome in a risk group of patients after cardiac surgery. Crit Care Med. 2003 Apr;31(4):1068-74. doi: 10.1097/01.CCM.0000059646.89546.98.
PubMed 12682474Loisa P, Uusaro A, Ruokonen E. A single adrenocorticotropic hormone stimulation test does not reveal adrenal insufficiency in septic shock. Anesth Analg. 2005 Dec;101(6):1792-1798. doi: 10.1213/01.ANE.0000184042.91452.48.
PubMed 16301260
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Anesthetic Induction Dose of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00415701
- Acronym / sponsor ID
- DINA-KEK7406-IBAN-2006-1
- Keywords
- Etomidate, Propofol, Adrenocortical Insufficiency, Hemodynamic Process, Vasoactive Agonists, Coronary Artery Bypass, Ischemic Coronary Heart Disease, Mitral valve reconstruction/replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Dec 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 evaluate the effect of a single dose of etomidate for patients undergoing cardiac surgery with the use of cardiopulmonary bypass (CPB) on post-CPB adrenocortical responsiveness, on requirements of hemodynamic support, and on use of intensive care resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: EtomidateEtomidate as a single induction dose |
| 2 | Active comparator | Drug: PropofolPropofol as a single induction dose |
| 3 | Other | Drug: Hydrocortisone, Drug: NaCl 0.9%, Other: TetracosactinHydrocortisone substitution or placebo (50-50%) in etomidate-group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients undergoing elective
- Age between 18 and 80 years (extremes included)
- Subject itself has signed the informed consent
- No clinically relevant deviation from the laboratory's reference range of biochemistry, hematology, or urinalysis testing
Key exclusion criteria (16 listed)
- Participation in another ongoing interventional trial
- Known adrenocortical insufficiency
- Use of etomidate or propofol within 1 week preoperatively
- Use of glucocorticoids within 6 month preoperatively
- Known sensitivity to etomidate, propofol, or emulgator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtomidateSingle induction dose of etomidate 0.2%; total dose 0.15 mg/kg | Drug | 1 |
| PropofolSingle induction dose of propofol 2%; total dose 1.5 mg/kg | Drug | 2 |
| HydrocortisoneHydrocortisone 100 mg/2 ml: day of operation 3x, POD 1 2x, POD 2 1x | Drug | 3 |
| NaCl 0.9%NaCl 0.9% 2 ml; day of operation 3x, POD 1 2x, POD 2 1x | Drug | 3 |
| TetracosactinDiagnostic test, Tetracosactin 250 microg iv | Other | 3 |
Primary outcome
Incidence of absolute and relative adrenal insufficiency
Time frame: Preoperative day to postoperative day (POD) 4
Cumulative requirements of vasoactive drugs during surgery and in the intensive care unit (ICU)
Time frame: Induction of anesthesia to POD 2
5 secondary outcomes
Incidence of failure to wean off cardiopulmonary bypass on first intention
Time frame: intraoperatively
Serum lactate
Time frame: Induction of anesthesia to discharge ICU
Time to extubation
Time frame: Induction of anesthesia to extubation
Length of stay (LOS) in the intensive care unit (ICU), intermediate care unit (IMC), and hospital
Time frame: Admission to discharge: ICU, IMC, and hospital
Association of results with preoperative risk, stress-dose hydrocortisone replacement, type of surgery
Time frame: 30 days
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 4 Mar 2010.
- Background: PubMed 15703896Malerba G, Romano-Girard F, Cravoisy A, Dousset B, Nace L, Levy B, Bollaert PE. Risk factors of relative adrenocortical deficiency in intensive care patients needing mechanical ventilation. Intensive Care Med. 2005 Mar;31(3):388-92. doi: 10.1007/s00134-004-2550-8. Epub 2005 Feb 10.
- Background: PubMed 16434254Weis F, Kilger E, Roozendaal B, de Quervain DJ, Lamm P, Schmidt M, Schmolz M, Briegel J, Schelling G. Stress doses of hydrocortisone reduce chronic stress symptoms and improve health-related quality of life in high-risk patients after cardiac surgery: a randomized study. J Thorac Cardiovasc Surg. 2006 Feb;131(2):277-82. doi: 10.1016/j.jtcvs.2005.07.063.
- Background: PubMed 15985474den Brinker M, Joosten KF, Liem O, de Jong FH, Hop WC, Hazelzet JA, van Dijk M, Hokken-Koelega AC. Adrenal insufficiency in meningococcal sepsis: bioavailable cortisol levels and impact of interleukin-6 levels and intubation with etomidate on adrenal function and mortality. J Clin Endocrinol Metab. 2005 Sep;90(9):5110-7. doi: 10.1210/jc.2005-1107. Epub 2005 Jun 28.
- Background: PubMed 10460557Absalom A, Pledger D, Kong A. Adrenocortical function in critically ill patients 24 h after a single dose of etomidate. Anaesthesia. 1999 Sep;54(9):861-7. doi: 10.1046/j.1365-2044.1999.01003.x.
- Background: PubMed 15750800Annane D. ICU physicians should abandon the use of etomidate! Intensive Care Med. 2005 Mar;31(3):325-6. doi: 10.1007/s00134-005-2560-1. Epub 2005 Jan 27. No abstract available.
- Background: PubMed 2982387Duthie DJ, Fraser R, Nimmo WS. Effect of induction of anaesthesia with etomidate on corticosteroid synthesis in man. Br J Anaesth. 1985 Feb;57(2):156-9. doi: 10.1093/bja/57.2.156.
- Background: PubMed 6322902Fellows IW, Bastow MD, Byrne AJ, Allison SP. Adrenocortical suppression in multiply injured patients: a complication of etomidate treatment. Br Med J (Clin Res Ed). 1983 Dec 17;287(6408):1835-7. doi: 10.1136/bmj.287.6408.1835.
- Background: PubMed 6134923Fellows IW, Byrne AJ, Allison SP. Adrenocortical suppression with etomidate. Lancet. 1983 Jul 2;2(8340):54-5. doi: 10.1016/s0140-6736(83)90043-0. No abstract available.
- Background: PubMed 6325910Wagner RL, White PF, Kan PB, Rosenthal MH, Feldman D. Inhibition of adrenal steroidogenesis by the anesthetic etomidate. N Engl J Med. 1984 May 31;310(22):1415-21. doi: 10.1056/NEJM198405313102202.
- Background: PubMed 6136774Allolio B, Stuttmann R, Fischer H, Leonhard W, Winkelmann W. Long-term etomidate and adrenocortical suppression. Lancet. 1983 Sep 10;2(8350):626. doi: 10.1016/s0140-6736(83)90710-9. No abstract available.
- Background: PubMed 3261141Crozier TA, Beck D, Wuttke W, Kettler D. [Relation of the inhibition of cortisol synthesis in vivo to plasma etomidate concentrations]. Anaesthesist. 1988 May;37(5):337-9. German.
- Background: PubMed 6496912Watt I, Ledingham IM. Mortality amongst multiple trauma patients admitted to an intensive therapy unit. Anaesthesia. 1984 Oct;39(10):973-81. doi: 10.1111/j.1365-2044.1984.tb08885.x.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Stephan M Jakob, Professor principal investigator
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etomidate, Propofol and Hydrocortisone in people with Coronary Artery Disease and Mitral Valve Regurgitation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 6 inclusion and 16 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 4 Mar 2010. 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 Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of absolute and relative adrenal insufficiency (time frame: Preoperative day to postoperative day (POD) 4). The study lists 2 primary outcomes in all. 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 NCT00415701, which also lists 17 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 4 Mar 2010.