Cardiac DiseaseNCT04635293

Preoperative Infusion of Levosimendan in Patients Undergoing Cardiac Surgery

A study testing preoperative infusion of levosimendan and no preoperative infusion of levosimendan in people with Cardiac Disease and Cardiac Failure, run by Aretaieion University Hospital at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this retrospective study will be to investigate the effect of the preoperative administration of levosimendan on the outcome of patients with compromised cardiac function undergoing cardiac surgery Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Cardiac Disease, Cardiac Failure, Cardiac Surgery
What is being tested?: preoperative infusion of levosimendan and no preoperative infusion of levosimendan
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteGreece
Study dates: 1 Jan 2012to 9 Nov 2020
Phase: Interventional
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

elective cardiac surgery
cardiac surgery under cardiopulmonary bypass
low ejection fraction (<40%)

Who cannot join

age <18 years old
urgent operation
glomerular filtration rate<30 ml/min
hepatic dysfunction preoperatively
side effects (hypotension, tachycardia, ST segment abnormalities during levosimendan administration
redo surgery

Trial locations and contacts

1 site in 1 country.

Greece1 site

Onassis Cardiac Surgery Center
Athens, 17674

Other trials in Greece

About this study

Official title: Preoperative Infusion of Levosimendan in High Risk Cardiac Surgery Patients: A Retrospective Study

Read the detailed description

Patients with severely reduced left ventricular ejection fraction (LVEF) face a high risk of morbidity and mortality after cardiac surgery. Impaired cardiac function preoperatively predisposes patients to low cardiac output syndrome. Levosimendan acts by a different mechanism than traditional inotropes and its preoperative use could improve the outcome of patients with cardiac failure. Specifically, it promotes vasodilation of coronary, pulmonary and systemic vessels, has an anti-inflammatory and anti-oxidant effect and enhances cardiac contractility by improving the response of the myofilaments to intracellular calcium.

Conditions: Cardiac Disease, Cardiac Failure, Cardiac Surgery, Inotropes, Ejection Fraction
Being tested: preoperative infusion of levosimendan, no preoperative infusion of levosimendan
Keywords: levosimendan, low output syndrome
Medical subject headings: Heart Diseases, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

preoperative infusion of levosimendanProcedure or surgery
the study group will consist of patients who have received a continuous infusion of levosimendan 0.1 μg/kg/min for 24 hours before cardiac surgery
no preoperative infusion of levosimendanProcedure or surgery
the control group will consist of patients who proceeded to the cardiac operation without any infusion for 24 hours preoperatively

Study groups in NCT04635293
Study group	Role	What they receive
patients who were administered levosimendan at a dose of 0.1µg/Kg/min for 24 hours prior to surgery	Active comparator	Not described Receives: Procedure: preoperative infusion of levosimendan
patients who were not administered levosimendan prior to surgery	Placebo comparator	Not described Receives: Procedure: no preoperative infusion of levosimendan

What is being measured

The primary outcome is the main question the study is designed to answer.

hours of mechanical ventilation
hours of mechanical ventilation during patient stay in Intensive Care Unit (ICU)
Measured: during stay in ICU, approximately 48 hours postoperatively
vasopressor use in operating room
need for vasopressor use, yes or no
Measured: intraoperatively, from induction to end of anesthesia, an average period of 3 hours
vasopressor use in ICU
need for vasopressor use, yes or no
Measured: during stay in ICU, approximately 48 hours postoperatively
inotrope use in operating room
need for inotrope use, yes or no
Measured: intraoperatively, from induction to end of anesthesia, an average period of 3 hours
inotrope use in ICU
need for inotrope use, yes or no
Measured: during stay in ICU, approximately 48 hours postoperatively
incidence of arrhythmias
development of new-onset arrhythmias, yes or no
Measured: postoperatively, an average period of 7-10 days
incidence of renal dysfunction
development of new-onset renal dysfunction, defined as an increase in creatinine levels over 0.3 mg/dL from the initial values
Measured: postoperatively, an average period of 7-10 days
length of ICU stay
duration of patient stay in ICU in days
Measured: postoperatively, an average period of 7-10 days
hospitalization time
duration of hospital stay after surgery in days
Measured: postoperatively, up to 20 days after the operation
incidence of death within the first 30 days after surgery
patient survival within the first 30 days after surgery, yes or no
Measured: 30 days after surgery
need of mechanical assist devices intraoperatively
need for mechanical assist devices, yes or no
Measured: intraoperatively, from induction to end of anesthesia, an average period of 3 hours and postoperatively, an average period of 7-10 days
need of mechanical assist devices postoperatively
need for mechanical assist devices, yes or no
Measured: postoperatively, an average period of 7-10 days
change from baseline in cardiac output (CO)
a Swan-Ganz catheter will be used for hemodynamic measurements
Measured: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
change from baseline in mean arterial pressure (MAP)
a Swan-Ganz catheter will be used for hemodynamic measurements
Measured: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
change from baseline in mean pulmonary arterial pressure (MPAP)
a Swan-Ganz catheter will be used for hemodynamic measurements
Measured: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
change from baseline in systemic vascular resistance (SVR)
a Swan-Ganz catheter will be used for hemodynamic measurements
Measured: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
change from baseline in pulmonary vascular resistance (PVR)
a Swan-Ganz catheter will be used for hemodynamic measurements
Measured: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
change from baseline in pulmonary capillary wedge pressure (PCWP)
a Swan-Ganz catheter will be used for hemodynamic measurements
Measured: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery),12 hours after ICU admittance, 24 hours after ICU admittance,
change from baseline in cardiac function
transesophageal echocardiography will be used for echocardiographic measurements
Measured: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20129 Nov 2020

First posted19 Nov 2020
Study start1 Jan 2012
Primary completion9 Nov 2020
Study completion9 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Cardiac 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 N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Retrospective
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04635293
Sponsor's protocol ID: 667/24.02.2020
Status last verified: Nov 2020
First submitted: 9 Nov 2020
Last updated: 19 Nov 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Tasouli A, Papadopoulos K, Antoniou T, Kriaras I, Stavridis G, Degiannis D, Geroulanos S. Efficacy and safety of perioperative infusion of levosimendan in patients with compromised cardiac function undergoing open-heart surgery: importance of early use. Eur J Cardiothorac Surg. 2007 Oct;32(4):629-33. doi: 10.1016/j.ejcts.2007.07.010. Epub 2007 Aug 15.
PubMed 17702589
Landoni G, Biondi-Zoccai G, Greco M, Greco T, Bignami E, Morelli A, Guarracino F, Zangrillo A. Effects of levosimendan on mortality and hospitalization. A meta-analysis of randomized controlled studies. Crit Care Med. 2012 Feb;40(2):634-46. doi: 10.1097/CCM.0b013e318232962a.
PubMed 21963578
Tritapepe L, De Santis V, Vitale D, Guarracino F, Pellegrini F, Pietropaoli P, Singer M. Levosimendan pre-treatment improves outcomes in patients undergoing coronary artery bypass graft surgery. Br J Anaesth. 2009 Feb;102(2):198-204. doi: 10.1093/bja/aen367.
PubMed 19151048
De Hert SG, Lorsomradee S, Cromheecke S, Van der Linden PJ. The effects of levosimendan in cardiac surgery patients with poor left ventricular function. Anesth Analg. 2007 Apr;104(4):766-73. doi: 10.1213/01.ane.0000256863.92050.d3.
PubMed 17377079
Kivikko M, Lehtonen L. Levosimendan: a new inodilatory drug for the treatment of decompensated heart failure. Curr Pharm Des. 2005;11(4):435-55. doi: 10.2174/1381612053382043.
PubMed 15725064
Mehta RH, Leimberger JD, van Diepen S, Meza J, Wang A, Jankowich R, Harrison RW, Hay D, Fremes S, Duncan A, Soltesz EG, Luber J, Park S, Argenziano M, Murphy E, Marcel R, Kalavrouziotis D, Nagpal D, Bozinovski J, Toller W, Heringlake M, Goodman SG, Levy JH, Harrington RA, Anstrom KJ, Alexander JH; LEVO-CTS Investigators. Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery. N Engl J Med. 2017 May 25;376(21):2032-2042. doi: 10.1056/NEJMoa1616218. Epub 2017 Mar 19.
PubMed 28316276
Cholley B, Caruba T, Grosjean S, Amour J, Ouattara A, Villacorta J, Miguet B, Guinet P, Levy F, Squara P, Ait Hamou N, Carillion A, Boyer J, Boughenou MF, Rosier S, Robin E, Radutoiu M, Durand M, Guidon C, Desebbe O, Charles-Nelson A, Menasche P, Rozec B, Girard C, Fellahi JL, Pirracchio R, Chatellier G; -. Effect of Levosimendan on Low Cardiac Output Syndrome in Patients With Low Ejection Fraction Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass: The LICORN Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):548-556. doi: 10.1001/jama.2017.9973.
PubMed 28787507
Papp Z, Edes I, Fruhwald S, De Hert SG, Salmenpera M, Leppikangas H, Mebazaa A, Landoni G, Grossini E, Caimmi P, Morelli A, Guarracino F, Schwinger RH, Meyer S, Algotsson L, Wikstrom BG, Jorgensen K, Filippatos G, Parissis JT, Gonzalez MJ, Parkhomenko A, Yilmaz MB, Kivikko M, Pollesello P, Follath F. Levosimendan: molecular mechanisms and clinical implications: consensus of experts on the mechanisms of action of levosimendan. Int J Cardiol. 2012 Aug 23;159(2):82-7. doi: 10.1016/j.ijcard.2011.07.022. Epub 2011 Jul 23.
PubMed 21784540

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preoperative Infusion of Levosimendan in High Risk Cardiac Surgery Patients: A Retrospective Study
ClinicalTrials.gov ID: NCT04635293
Acronym / sponsor ID: 667/24.02.2020
Conditions: Cardiac Disease, Cardiac Failure, Cardiac Surgery, Inotropes, Ejection Fraction
Keywords: levosimendan, low output syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Aretaieion University HospitalUniversity, hospital or other
Study start: 1 Jan 2012 (actual)
Primary completion: 9 Nov 2020 (actual)
Study completion: 9 Nov 2020 (actual)
First posted: 19 Nov 2020 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Retrospective

Arm	Type	Receives
patients who were administered levosimendan at a dose of 0.1µg/Kg/min for 24 hours prior to surgery	Active comparator	Procedure: preoperative infusion of levosimendan
patients who were not administered levosimendan prior to surgery	Placebo comparator	Procedure: no preoperative infusion of levosimendan

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

elective cardiac surgery
cardiac surgery under cardiopulmonary bypass
low ejection fraction (<40%)

Key exclusion criteria (6 listed)

age <18 years old
urgent operation
glomerular filtration rate<30 ml/min
hepatic dysfunction preoperatively
side effects (hypotension, tachycardia, ST segment abnormalities during levosimendan administration

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
preoperative infusion of levosimendanthe study group will consist of patients who have received a continuous infusion of levosimendan 0.1 μg/kg/min for 24 hours before cardiac surgery	Procedure or surgery	patients who were administered levosimendan at a dose of 0.1µg/Kg/min for 24 hours prior to surgery
no preoperative infusion of levosimendanthe control group will consist of patients who proceeded to the cardiac operation without any infusion for 24 hours preoperatively	Procedure or surgery	patients who were not administered levosimendan prior to surgery

Primary outcome

hours of mechanical ventilation
Time frame: during stay in ICU, approximately 48 hours postoperatively
hours of mechanical ventilation during patient stay in Intensive Care Unit (ICU)
vasopressor use in operating room
Time frame: intraoperatively, from induction to end of anesthesia, an average period of 3 hours
need for vasopressor use, yes or no
vasopressor use in ICU
Time frame: during stay in ICU, approximately 48 hours postoperatively
need for vasopressor use, yes or no
inotrope use in operating room
Time frame: intraoperatively, from induction to end of anesthesia, an average period of 3 hours
need for inotrope use, yes or no
inotrope use in ICU
Time frame: during stay in ICU, approximately 48 hours postoperatively
need for inotrope use, yes or no
incidence of arrhythmias
Time frame: postoperatively, an average period of 7-10 days
development of new-onset arrhythmias, yes or no
incidence of renal dysfunction
Time frame: postoperatively, an average period of 7-10 days
development of new-onset renal dysfunction, defined as an increase in creatinine levels over 0.3 mg/dL from the initial values
length of ICU stay
Time frame: postoperatively, an average period of 7-10 days
duration of patient stay in ICU in days
hospitalization time
Time frame: postoperatively, up to 20 days after the operation
duration of hospital stay after surgery in days
incidence of death within the first 30 days after surgery
Time frame: 30 days after surgery
patient survival within the first 30 days after surgery, yes or no
need of mechanical assist devices intraoperatively
Time frame: intraoperatively, from induction to end of anesthesia, an average period of 3 hours and postoperatively, an average period of 7-10 days
need for mechanical assist devices, yes or no
need of mechanical assist devices postoperatively
Time frame: postoperatively, an average period of 7-10 days
need for mechanical assist devices, yes or no
change from baseline in cardiac output (CO)
Time frame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
a Swan-Ganz catheter will be used for hemodynamic measurements
change from baseline in mean arterial pressure (MAP)
Time frame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
a Swan-Ganz catheter will be used for hemodynamic measurements
change from baseline in mean pulmonary arterial pressure (MPAP)
Time frame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
a Swan-Ganz catheter will be used for hemodynamic measurements
change from baseline in systemic vascular resistance (SVR)
Time frame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
a Swan-Ganz catheter will be used for hemodynamic measurements
change from baseline in pulmonary vascular resistance (PVR)
Time frame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
a Swan-Ganz catheter will be used for hemodynamic measurements
change from baseline in pulmonary capillary wedge pressure (PCWP)
Time frame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery),12 hours after ICU admittance, 24 hours after ICU admittance,
a Swan-Ganz catheter will be used for hemodynamic measurements
change from baseline in cardiac function
Time frame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery)
transesophageal echocardiography will be used for echocardiographic measurements

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 19 Nov 2020.
Background: PubMed 17702589Tasouli A, Papadopoulos K, Antoniou T, Kriaras I, Stavridis G, Degiannis D, Geroulanos S. Efficacy and safety of perioperative infusion of levosimendan in patients with compromised cardiac function undergoing open-heart surgery: importance of early use. Eur J Cardiothorac Surg. 2007 Oct;32(4):629-33. doi: 10.1016/j.ejcts.2007.07.010. Epub 2007 Aug 15.
Background: PubMed 21963578Landoni G, Biondi-Zoccai G, Greco M, Greco T, Bignami E, Morelli A, Guarracino F, Zangrillo A. Effects of levosimendan on mortality and hospitalization. A meta-analysis of randomized controlled studies. Crit Care Med. 2012 Feb;40(2):634-46. doi: 10.1097/CCM.0b013e318232962a.
Background: PubMed 19151048Tritapepe L, De Santis V, Vitale D, Guarracino F, Pellegrini F, Pietropaoli P, Singer M. Levosimendan pre-treatment improves outcomes in patients undergoing coronary artery bypass graft surgery. Br J Anaesth. 2009 Feb;102(2):198-204. doi: 10.1093/bja/aen367.
Background: PubMed 17377079De Hert SG, Lorsomradee S, Cromheecke S, Van der Linden PJ. The effects of levosimendan in cardiac surgery patients with poor left ventricular function. Anesth Analg. 2007 Apr;104(4):766-73. doi: 10.1213/01.ane.0000256863.92050.d3.
Background: PubMed 15725064Kivikko M, Lehtonen L. Levosimendan: a new inodilatory drug for the treatment of decompensated heart failure. Curr Pharm Des. 2005;11(4):435-55. doi: 10.2174/1381612053382043.
Background: PubMed 28316276Mehta RH, Leimberger JD, van Diepen S, Meza J, Wang A, Jankowich R, Harrison RW, Hay D, Fremes S, Duncan A, Soltesz EG, Luber J, Park S, Argenziano M, Murphy E, Marcel R, Kalavrouziotis D, Nagpal D, Bozinovski J, Toller W, Heringlake M, Goodman SG, Levy JH, Harrington RA, Anstrom KJ, Alexander JH; LEVO-CTS Investigators. Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery. N Engl J Med. 2017 May 25;376(21):2032-2042. doi: 10.1056/NEJMoa1616218. Epub 2017 Mar 19.
Background: PubMed 28787507Cholley B, Caruba T, Grosjean S, Amour J, Ouattara A, Villacorta J, Miguet B, Guinet P, Levy F, Squara P, Ait Hamou N, Carillion A, Boyer J, Boughenou MF, Rosier S, Robin E, Radutoiu M, Durand M, Guidon C, Desebbe O, Charles-Nelson A, Menasche P, Rozec B, Girard C, Fellahi JL, Pirracchio R, Chatellier G; -. Effect of Levosimendan on Low Cardiac Output Syndrome in Patients With Low Ejection Fraction Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass: The LICORN Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):548-556. doi: 10.1001/jama.2017.9973.
Background: PubMed 21784540Papp Z, Edes I, Fruhwald S, De Hert SG, Salmenpera M, Leppikangas H, Mebazaa A, Landoni G, Grossini E, Caimmi P, Morelli A, Guarracino F, Schwinger RH, Meyer S, Algotsson L, Wikstrom BG, Jorgensen K, Filippatos G, Parissis JT, Gonzalez MJ, Parkhomenko A, Yilmaz MB, Kivikko M, Pollesello P, Follath F. Levosimendan: molecular mechanisms and clinical implications: consensus of experts on the mechanisms of action of levosimendan. Int J Cardiol. 2012 Aug 23;159(2):82-7. doi: 10.1016/j.ijcard.2011.07.022. Epub 2011 Jul 23.
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.

Kassiani Theodoraki, PhD, DESA principal investigator

Aretaieion University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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 19 Nov 2020. 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 Greece. 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. Some participants in this study may receive a placebo. 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?

hours of mechanical ventilation (time frame: during stay in ICU, approximately 48 hours postoperatively). The study lists 19 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 NCT04635293, which also lists 8 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 19 Nov 2020.