Coronary Artery DiseasePhase 4ETOPRONCT06068764
Etomidate Versus Propofol in CABG Surgery
A Phase 4 study testing Etomidate and Propofol in people with Coronary Artery Disease, run by Hartford Hospital at 1 site in United States.
Trial summary
The objective of this single-blinded randomized controlled interventional clinical trial is to learn about the efficacy and long-term safety of etomidate compared to propofol as an anesthesia induction agent in patients undergoing coronary artery bypass graft (CABG) surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Etomidate and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2023to Aug 2026
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective open coronary arteries bypass graft CABG surgery
- Patients with American Society of Anesthesiology (ASA) physical status score I- IV
- Patients with the ability to speak and read both English and Spanish
Who cannot join
- Emergency CABG surgery, STAT cases, and add-on cases.
- Refusal or lack of providing the study consent
- Patients with a known current adrenocortical insufficiency
- A patient who is presenting with any kind of shock, (e.g. septic, hypovolemic, cardiogenic, etc.)
- Patients with chronic steroid use (defined as the use of glucocorticoids within 6 months preoperatively)
- Patients with a known allergy to etomidate or propofol.
- Patients with a known seizure disorder.
- Patients who are enrolled in other clinical research studies that can compete with this study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06106
Aseel Walker, MD, 860-972-1778, aseel.walker@hhchealth.org
Joseph Hinchey, MD
About this study
Official title: Etomidate Versus Propofol As An Anesthesia Induction Agent For Patients Undergoing CABG Surgery, Assessing Hemodynamic Stability. A Single Blinded, Randomized Controlled Trial.
The objective of this single-blinded randomized controlled interventional clinical trial is to learn about the efficacy and long-term safety of etomidate compared to propofol as an anesthesia induction agent in patients undergoing coronary artery bypass graft (CABG) surgery. The primary aim of this study is to determine whether patients receiving etomidate or propofol exhibit similar requirements for vasopressor or ionotropic agents during both the intraoperative and postoperative periods.
To achieve this goal, participants who are scheduled for CABG surgery will be randomly assigned to receive either etomidate or propofol as the principal hypnotic agent. The researchers will then compare the effects of these two anesthesia induction agents on various factors, including the need for hemodynamic support, hemodynamic stability, duration of mechanical ventilation, length of stay in the intensive care unit (ICU), and overall hospital length of stay. Additionally, they will assess whether there are disparities in mortality rates and readmission rates within a 6-month timeframe after the surgery.
By comparing the outcomes between the two groups, the study aims to provide valuable insights into the potential differences in vasopressor or ionotropic agent requirements between etomidate and propofol. This information can help inform clinical decision-making and potentially optimize anesthesia management strategies for patients undergoing CABG surgery.
- Conditions
- Coronary Artery Disease
- Being tested
- Etomidate, Propofol
- Keywords
- CABG surgery, Etomidate, Propofol, general anesthesia induction agenats, cardiothoracic anesthesia
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtomidateDrug
Also called Amidate™
The type of general anesthesia induction agent for CABG surgery
PropofolDrug
Also called Diprivan
The type of general anesthesia induction agent for CABG surgery
| Study group | Role | What they receive |
|---|---|---|
| Etomidate | Experimental | Etomidate as the principal hypnotic agent in a single bolus dose of 0.2-0.3 mg/kg along with 250mcg of fentanyl, 50mg ketamine, 0.7 mg/kg rocuronium, and 5ml of 2% lidocaine. Receives: Drug: Etomidate |
| Propofol | Active comparator | Propofol as the principal hypnotic agent in a single bolus dose of 50mg of propofol along with 250 mcg of fentanyl, 50mg ketamine, 0.7 mg/kg rocuronium, and 5ml of 2% lidocaine. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasopressors dose expressed by Noradrenaline Equivalent dose [μg/kg/min]
Vasopressor requirements will be expressed as Noradrenaline Equivalent dose using the formula of (NEq [μg/kg/min] = norepinephrine + epinephrine + phenylephrine/10 + dopamine/100 + vasopressin*2.5), this will be measured during three periods of time: Intraoperatively during the first 30 minutes post induction (as a reflection of the impact of induction on hemodynamics), intraoperatively during the last 30 minutes of the post bypass period, and for the first 24 hours post procedure.
Measured: 30 minutes after induction, last 30 minutes of post bypass period, and first 24 hours post procedure.
Secondary outcomes (6)
The number of incidences of shock
The incidence of both vasogenic and cardiogenic shocks will be determined intraoperatively and postoperatively using the Mean Arterial Pressure (MAP), Central Venous Pressure (CVP), Cardiac Output (CO), and Systemic Vascular Resistance (SVR).
Vasogenic shock (defined as a MAP < 60 mmHg with normal CO (>2.0 L/min) and low SVR (< 900 dynes/sec).
Cardiogenic shock (defined as hypotension with MAP < 60 mmHg, low CO (<2.0 L/min), and normal SVR range (900-1400 dynes/sec).
Measured: First 24 hours post anesthesia
ICU length of stay
ICU length of stay will be calculated in hours using the ICU data from EPIC.
Measured: 3 days
Hospital length of stay
Hospital length of stay will be calculated in hours from the date and time of admission and discharge, from EPIC.
Measured: 7 days
Hospital Readmissions
In the 6th month after surgery, a retrospective safety checkup will be done, using EPIC chart review, to assess the number of readmissions.
Measured: 6 months
Time to extubation and end of mechanical ventilation
Time to extubation, the standard of care is usually within 6 hours of arriving to the unit.
Measured: until extubation, assessed as 6 hours
Incidence of Death
In the 6th month after surgery, a retrospective safety checkup will be done, using EPIC chart review, to assess the number of deaths if any.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start5 Dec 2023
- Primary completionDec 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, prospective, single-blinded, randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Hinchey, Hartford Hospital
- Investigators
- Joseph Hinchey, MD, Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068764
- Sponsor's protocol ID
- HHC-2023-0114
- Acronym
- ETOPRO
- Status last verified
- Dec 2023
- First submitted
- 10 Aug 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hildreth AN, Mejia VA, Maxwell RA, Smith PW, Dart BW, Barker DE. Adrenal suppression following a single dose of etomidate for rapid sequence induction: a prospective randomized study. J Trauma. 2008 Sep;65(3):573-9. doi: 10.1097/TA.0b013e31818255e8.
PubMed 18784570De Jong A, Jaber S. Etomidate for anesthesia induction: friends or foe in major cardiac surgery? Crit Care. 2014 Oct 10;18(5):560. doi: 10.1186/s13054-014-0560-7.
PubMed 25672223Ledingham IM, Watt I. Influence of sedation on mortality in critically ill multiple trauma patients. Lancet. 1983 Jun 4;1(8336):1270. doi: 10.1016/s0140-6736(83)92712-5. No abstract available.
PubMed 6134053Chan CM, Mitchell AL, Shorr AF. Etomidate is associated with mortality and adrenal insufficiency in sepsis: a meta-analysis*. Crit Care Med. 2012 Nov;40(11):2945-53. doi: 10.1097/CCM.0b013e31825fec26.
PubMed 22971586Erdoes G, Basciani RM, Eberle B. Etomidate--a review of robust evidence for its use in various clinical scenarios. Acta Anaesthesiol Scand. 2014 Apr;58(4):380-9. doi: 10.1111/aas.12289. Epub 2014 Mar 3.
PubMed 24588359Jabre P, Combes X, Lapostolle F, Dhaouadi M, Ricard-Hibon A, Vivien B, Bertrand L, Beltramini A, Gamand P, Albizzati S, Perdrizet D, Lebail G, Chollet-Xemard C, Maxime V, Brun-Buisson C, Lefrant JY, Bollaert PE, Megarbane B, Ricard JD, Anguel N, Vicaut E, Adnet F; KETASED Collaborative Study Group. Etomidate versus ketamine for rapid sequence intubation in acutely ill patients: a multicentre randomised controlled trial. Lancet. 2009 Jul 25;374(9686):293-300. doi: 10.1016/S0140-6736(09)60949-1. Epub 2009 Jul 1.
PubMed 19573904McPhee LC, Badawi O, Fraser GL, Lerwick PA, Riker RR, Zuckerman IH, Franey C, Seder DB. Single-dose etomidate is not associated with increased mortality in ICU patients with sepsis: analysis of a large electronic ICU database. Crit Care Med. 2013 Mar;41(3):774-83. doi: 10.1097/CCM.0b013e318274190d.
PubMed 23318491Hohl CM, Kelly-Smith CH, Yeung TC, Sweet DD, Doyle-Waters MM, Schulzer M. The effect of a bolus dose of etomidate on cortisol levels, mortality, and health services utilization: a systematic review. Ann Emerg Med. 2010 Aug;56(2):105-13.e5. doi: 10.1016/j.annemergmed.2010.01.030. Epub 2010 Mar 25.
PubMed 20346542Wagner CE, Bick JS, Johnson D, Ahmad R, Han X, Ehrenfeld JM, Schildcrout JS, Pretorius M. Etomidate use and postoperative outcomes among cardiac surgery patients. Anesthesiology. 2014 Mar;120(3):579-89. doi: 10.1097/ALN.0000000000000087.
PubMed 24296761Heinrich S, Schmidt J, Ackermann A, Moritz A, Harig F, Castellanos I. Comparison of clinical outcome variables in patients with and without etomidate-facilitated anesthesia induction ahead of major cardiac surgery: a retrospective analysis. Crit Care. 2014 Jul 11;18(4):R150. doi: 10.1186/cc13988.
PubMed 25015112Basciani RM, Rindlisbacher A, Begert E, Brander L, Jakob SM, Etter R, Carrel T, Eberle B. Anaesthetic induction with etomidate in cardiac surgery: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jun;33(6):417-24. doi: 10.1097/EJA.0000000000000434.
PubMed 26914224Morel J, Salard M, Castelain C, Bayon MC, Lambert P, Vola M, Auboyer C, Molliex S. Haemodynamic consequences of etomidate administration in elective cardiac surgery: a randomized double-blinded study. Br J Anaesth. 2011 Oct;107(4):503-9. doi: 10.1093/bja/aer169. Epub 2011 Jun 17.
PubMed 21685487Iribarren JL, Jimenez JJ, Hernandez D, Lorenzo L, Brouard M, Milena A, Mora ML, Martinez R. Relative adrenal insufficiency and hemodynamic status in cardiopulmonary bypass surgery patients. A prospective cohort study. J Cardiothorac Surg. 2010 Apr 19;5:26. doi: 10.1186/1749-8090-5-26.
PubMed 20403156Hannam JA, Mitchell SJ, Cumin D, Frampton C, Merry AF, Moore MR, Kruger CJ. Haemodynamic profiles of etomidate vs propofol for induction of anaesthesia: a randomised controlled trial in patients undergoing cardiac surgery. Br J Anaesth. 2019 Feb;122(2):198-205. doi: 10.1016/j.bja.2018.09.027. Epub 2018 Nov 15.
PubMed 30686305Goradia S, Sardaneh AA, Narayan SW, Penm J, Patanwala AE. Vasopressor dose equivalence: A scoping review and suggested formula. J Crit Care. 2021 Feb;61:233-240. doi: 10.1016/j.jcrc.2020.11.002. Epub 2020 Nov 14.
PubMed 33220576
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etomidate Versus Propofol As An Anesthesia Induction Agent For Patients Undergoing CABG Surgery, Assessing Hemodynamic Stability. A Single Blinded, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06068764
- Acronym / sponsor ID
- ETOPRO / HHC-2023-0114
- Conditions
- Coronary Artery Disease
- Keywords
- CABG surgery, Etomidate, Propofol, general anesthesia induction agenats, cardiothoracic anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 5 Oct 2023 (actual)
- 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 objective of this single-blinded randomized controlled interventional clinical trial is to learn about the efficacy and long-term safety of etomidate compared to propofol as an anesthesia induction agent in patients undergoing coronary artery bypass graft (CABG) surgery. The primary aim of this study is to determine whether patients receiving etomidate or propofol exhibit similar requirements for vasopressor or ionotropic agents during both the intraoperative and postoperative periods.
To achieve this goal, participants who are scheduled for CABG surgery will be randomly assigned to receive either etomidate or propofol as the principal hypnotic agent. The researchers will then compare the effects of these two anesthesia induction agents on various factors, including the need for hemodynamic support, hemodynamic stability, duration of mechanical ventilation, length of stay in the intensive care unit (ICU), and overall hospital length of stay. Additionally, they will assess whether there are disparities in mortality rates and readmission rates within a 6-month timeframe after the surgery.
By comparing the outcomes between the two groups, the study aims to provide valuable insights into the potential differences in vasopressor or ionotropic agent requirements between etomidate and propofol. This information can help inform clinical decision-making and potentially optimize anesthesia management strategies for patients undergoing CABG surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-center, prospective, single-blinded, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Etomidate | Experimental | Drug: EtomidateEtomidate as the principal hypnotic agent in a single bolus dose of 0.2-0.3 mg/kg along with 250mcg of fentanyl, 50mg ketamine, 0.7 mg/kg rocuronium, and 5ml of 2% lidocaine. |
| Propofol | Active comparator | Drug: PropofolPropofol as the principal hypnotic agent in a single bolus dose of 50mg of propofol along with 250 mcg of fentanyl, 50mg ketamine, 0.7 mg/kg rocuronium, and 5ml of 2% lidocaine. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for elective open coronary arteries bypass graft CABG surgery
- Patients with American Society of Anesthesiology (ASA) physical status score I- IV
- Patients with the ability to speak and read both English and Spanish
Key exclusion criteria (8 listed)
- Emergency CABG surgery, STAT cases, and add-on cases.
- Refusal or lack of providing the study consent
- Patients with a known current adrenocortical insufficiency
- A patient who is presenting with any kind of shock, (e.g. septic, hypovolemic, cardiogenic, etc.)
- Patients with chronic steroid use (defined as the use of glucocorticoids within 6 months preoperatively)
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 |
|---|---|---|
| EtomidateAlso: Amidate™The type of general anesthesia induction agent for CABG surgery | Drug | Etomidate |
| PropofolAlso: DiprivanThe type of general anesthesia induction agent for CABG surgery | Drug | Propofol |
Primary outcome
Vasopressors dose expressed by Noradrenaline Equivalent dose [μg/kg/min]
Time frame: 30 minutes after induction, last 30 minutes of post bypass period, and first 24 hours post procedure.
Vasopressor requirements will be expressed as Noradrenaline Equivalent dose using the formula of (NEq [μg/kg/min] = norepinephrine + epinephrine + phenylephrine/10 + dopamine/100 + vasopressin*2.5), this will be measured during three periods of time: Intraoperatively during the first 30 minutes post induction (as a reflection of the impact of induction on hemodynamics), intraoperatively during the last 30 minutes of the post bypass period, and for the first 24 hours post procedure.
6 secondary outcomes
The number of incidences of shock
Time frame: First 24 hours post anesthesia
ICU length of stay
Time frame: 3 days
Hospital length of stay
Time frame: 7 days
Hospital Readmissions
Time frame: 6 months
Time to extubation and end of mechanical ventilation
Time frame: until extubation, assessed as 6 hours
Incidence of Death
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Background: PubMed 18784570Hildreth AN, Mejia VA, Maxwell RA, Smith PW, Dart BW, Barker DE. Adrenal suppression following a single dose of etomidate for rapid sequence induction: a prospective randomized study. J Trauma. 2008 Sep;65(3):573-9. doi: 10.1097/TA.0b013e31818255e8.
- Background: PubMed 25672223De Jong A, Jaber S. Etomidate for anesthesia induction: friends or foe in major cardiac surgery? Crit Care. 2014 Oct 10;18(5):560. doi: 10.1186/s13054-014-0560-7.
- Background: PubMed 6134053Ledingham IM, Watt I. Influence of sedation on mortality in critically ill multiple trauma patients. Lancet. 1983 Jun 4;1(8336):1270. doi: 10.1016/s0140-6736(83)92712-5. No abstract available.
- Background: PubMed 22971586Chan CM, Mitchell AL, Shorr AF. Etomidate is associated with mortality and adrenal insufficiency in sepsis: a meta-analysis*. Crit Care Med. 2012 Nov;40(11):2945-53. doi: 10.1097/CCM.0b013e31825fec26.
- Background: PubMed 24588359Erdoes G, Basciani RM, Eberle B. Etomidate--a review of robust evidence for its use in various clinical scenarios. Acta Anaesthesiol Scand. 2014 Apr;58(4):380-9. doi: 10.1111/aas.12289. Epub 2014 Mar 3.
- Background: PubMed 19573904Jabre P, Combes X, Lapostolle F, Dhaouadi M, Ricard-Hibon A, Vivien B, Bertrand L, Beltramini A, Gamand P, Albizzati S, Perdrizet D, Lebail G, Chollet-Xemard C, Maxime V, Brun-Buisson C, Lefrant JY, Bollaert PE, Megarbane B, Ricard JD, Anguel N, Vicaut E, Adnet F; KETASED Collaborative Study Group. Etomidate versus ketamine for rapid sequence intubation in acutely ill patients: a multicentre randomised controlled trial. Lancet. 2009 Jul 25;374(9686):293-300. doi: 10.1016/S0140-6736(09)60949-1. Epub 2009 Jul 1.
- Background: PubMed 23318491McPhee LC, Badawi O, Fraser GL, Lerwick PA, Riker RR, Zuckerman IH, Franey C, Seder DB. Single-dose etomidate is not associated with increased mortality in ICU patients with sepsis: analysis of a large electronic ICU database. Crit Care Med. 2013 Mar;41(3):774-83. doi: 10.1097/CCM.0b013e318274190d.
- Background: PubMed 20346542Hohl CM, Kelly-Smith CH, Yeung TC, Sweet DD, Doyle-Waters MM, Schulzer M. The effect of a bolus dose of etomidate on cortisol levels, mortality, and health services utilization: a systematic review. Ann Emerg Med. 2010 Aug;56(2):105-13.e5. doi: 10.1016/j.annemergmed.2010.01.030. Epub 2010 Mar 25.
- Background: PubMed 24296761Wagner CE, Bick JS, Johnson D, Ahmad R, Han X, Ehrenfeld JM, Schildcrout JS, Pretorius M. Etomidate use and postoperative outcomes among cardiac surgery patients. Anesthesiology. 2014 Mar;120(3):579-89. doi: 10.1097/ALN.0000000000000087.
- Background: PubMed 25015112Heinrich S, Schmidt J, Ackermann A, Moritz A, Harig F, Castellanos I. Comparison of clinical outcome variables in patients with and without etomidate-facilitated anesthesia induction ahead of major cardiac surgery: a retrospective analysis. Crit Care. 2014 Jul 11;18(4):R150. doi: 10.1186/cc13988.
- Background: PubMed 26914224Basciani RM, Rindlisbacher A, Begert E, Brander L, Jakob SM, Etter R, Carrel T, Eberle B. Anaesthetic induction with etomidate in cardiac surgery: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jun;33(6):417-24. doi: 10.1097/EJA.0000000000000434.
- Background: PubMed 21685487Morel J, Salard M, Castelain C, Bayon MC, Lambert P, Vola M, Auboyer C, Molliex S. Haemodynamic consequences of etomidate administration in elective cardiac surgery: a randomized double-blinded study. Br J Anaesth. 2011 Oct;107(4):503-9. doi: 10.1093/bja/aer169. Epub 2011 Jun 17.
- Individual participant dataSharing planned: No
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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.
Joseph Hinchey, MD principal investigator
Hartford Hospital
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 and Propofol in people with Coronary Artery Disease, run by Hartford Hospital at 1 site in United States.
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 3 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: status not confirmed, as of the sponsor's last update on 28 Dec 2023. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aseel Walker, MD (860-972-1778, Aseel.Walker@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasopressors dose expressed by Noradrenaline Equivalent dose [μg/kg/min] (time frame: 30 minutes after induction, last 30 minutes of post bypass period, and first 24 hours post procedure.). 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 NCT06068764, which also lists 15 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 28 Dec 2023.