Acute Circulatory FailureEVERDACNCT03680963
Early Versus Differed Arterial Catheterization in Critically Ill Patients With Acute Circulatory Failure:
A study testing Non-invasive strategy in people with Acute Circulatory Failure, run by University Hospital, Tours at 9 sites in France.
Trial summary
The objective of the present research is a combination of a one-sided test of non-inferiority and a one-sided test of superiority. A stepped approach will be used to evaluate these hypotheses: 1. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Circulatory Failure
- What is being tested?
- Non-invasive strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,010 participants
- Where
- 9 sitesFrance
- Study dates
- 15 Nov 2018to 28 Feb 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years the day of inclusion
- Existence of an acute circulatory failure defined by the presence of the following items 1 and 2:
- Persisting hypotension (systolic blood pressure less than 90 mmHg or mean arterial blood pressure less than 65 mmHg) for more than 15 min at intensive care unit admission or within the following 24 hours, OR requirement of continuous intravenous vasopressor treatment (i.e. any dose of norepinephrine / epinephrine)
- Presence at least one of the following signs of hypoperfusion: alteration of mental status; skin mottling; oliguria defined as a urine output < 0.5 mL/kg body weight for at least one hour; arterial lactate > 2 mmol/L; peripheral venous lactate > 3.2 mmol/L; ScvO2 <70%
- Free express oral and informed consent of the patient or a proxy in case of impossibility for the patient to consent; emergency inclusion possible when legal representatives and patient's family are not available
- French health insurance holder
Who cannot join
- Acute circulatory failure, as defined by items 1 and 2 in inclusion criteria list (cf. supra) present for more than 24 hours
- Non invasive blood pressure (NIBP) device fails to display a blood pressure value, or cuff placement impossible
- Patient for whom an Extra-Corporeal Membrane Oxygenation (ECMO) therapy (either veno-arterial or venous-venous) is already in place or is to be initiated within the next 6 hours
- Patient treated with vasopressor doses of more than 2.5 μg/kg/min of norepinephrine tartrate plus epinephrine for at least 2 hours (i.e., for instance, more than 8 mg of norepinephrine tartrate in 50 mL at the rate of 66 mL/hour for a patient weighing 70 kg) (please note that in fact this dosage corresponds to 1.25 μg/kg/min of norepinephrine base)
- Severe traumatic brain injury (i.e., traumatic brain injury with a Glasgow coma scale score of less than 9 before sedation)
- Patient previously included in the trial
Show all 11Show fewer
- Body mass index (BMI) above 40 kg/m2
- Pregnancy
- Brain death
- Moribund patient
- Patient known, at time of inclusion, as being under guardianship, authorship or curators
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Intensive care
Argenteuil
Intensive care
Dijon
Intensive care
La Roche-sur-Yon
Intensive care
Montauban
Intensive care
Nantes
Intensive care
Orléans
Intensive care
Poitiers
Intensive care
Strasbourg
Intensive care
Tours
About this study
Official title: Early Versus Differed Arterial Catheterization in Critically Ill Patients With Acute Circulatory Failure: A Multicentre, Open-label, Pragmatic, Randomised, Non-inferiority Controlled Trial (EVERDAC Trial)
The objective of the present research is a combination of a one-sided test of non-inferiority and a one-sided test of superiority. A stepped approach will be used to evaluate these hypotheses:
- a less invasive intervention (i.e., no indwelling arterial catheter insertion until felt absolutely needed, according to consensual and predefined safety criteria) is non inferior to usual care (i.e., systematic indwelling arterial catheter insertion in the early hours of shock) in terms of mortality at day 28 (non-inferiority margin of 5%).
- a less invasive intervention is not only non-inferior but also superior to usual care in terms of mortality.
Multi-centre, pragmatic, randomised, controlled, open, two-parallel group, non-inferiority clinical trial.
- Conditions
- Acute Circulatory Failure
- Being tested
- Non-invasive strategy, Control strategy
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive strategyProcedure or surgery
No indwelling arterial catheter insertion will be allowed during the first 28 days, excepted if predefined safety criteria (indicating absolute need of indwelling arterial catheter insertion) are reached.
In the "non-invasive" group, automated oscillometric monitor will be used to monitor BP (blood pressure).
Control strategyProcedure or surgery
An indwelling arterial catheter will be inserted as soon as possible (within the first four hours after randomization) and will be maintained except in case of indwelling arterial catheter futility, suspected or proven indwelling arterial catheter related infection or thrombosis (at discretion of attending physician) until day 28 or ICU (Intensive Care Unit) discharge (whichever comes first). After day 28, clinicians may choose to maintain or to remove indwelling arterial catheter.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive strategy | Experimental | Non-invasive strategy consisting of blood pressure monitoring by non-invasive automated cuff measurements Receives: Procedure: Non-invasive strategy |
| Control strategy | Other | Usual strategy of systematic indwelling arterial catheter insertion in the early hours of acute circulatory failure Receives: Procedure: Control strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality by 28 days after randomisation
Measured: Patients will be followed from randomization to day 28
Secondary outcomes (36)
To account for the potential bias brought by deaths occurring as the result of life-sustaining treatments withdrawal/withholding, as frequently encountered in intensive care unit, the investigators will record such events
Measured: From inclusion to Day 35
Cumulative incidence of death
Measured: From inclusion through Day 90
Cumulative survival free of indwelling arterial catheter insertion
Measured: From inclusion through Day 90
Number of patients who underwent indwelling arterial catheter insertion, in both groups
Measured: From randomization to Day 28
Evolution of daily Sequential Organ Failure Assessment (SOFA) score
The score (ranged from 0 to 24, the worth outcome) is based on six sub-scores (each ranged from 0 to 4, the worth outcome), one for each respiratory system, neurological, cardiovascular, hepatic, renal and coagulation.
Measured: During the first seven days
Daily amount of intravenous fluid given for rapid vascular volume expansion
Measured: From Day 1 to Day 7
Duration of mechanical ventilation
Measured: From inclusion to Day 28
Ventilator-free days
Patients dying between randomisation and Day 28 will be assigned a 0 value; for survivors at Day 28, all the days free of invasive mechanical ventilation through an endotracheal tube within the 28-day period will be taken into account
Measured: From Day 1 to Day 28
Proportion of patients treated by renal-replacement therapy
Measured: Between Day 1 and Day 28
Renal replacement therapy-free days
Days without renal replacement therapy from Day 1 to Day 28 for survivors at Day 28, and from Day 1 to the date of death for patients dying before Day 28, will be taken into account
Measured: From Day 1 to Day 28
Proportion of patients treated by vasopressor
Measured: Between Day 1 and Day 28
Vasopressor therapy-free days
Days without vasopressor therapy from Day 1 to Day 28 for survivors at Day 28, and from Day 1 to the date of death for patients dying before Day 28, will be taken into account
Measured: From Day 1 to Day 28
Mean daily blood volume drawn for lab testing during intensive care unit stay
Measured: From inclusion to Day 28
Number of blood cultures performed during intensive care unit stay
Measured: From inclusion to Day 28
Number of attempts at arterial puncture during intensive care unit stay
Measured: From inclusion to Day 28
Evolution of blood haemoglobin level
Measured: From Day 1 to Day 28
Evolution of haematocrit
Measured: From Day 1 to Day 28
Number of red blood cell packs transfused
Measured: From Day 1 to Day 28
Number of transcutaneous arterial and venous puncture for lab tests, arterial catheter insertion and set up of monitor, blood drawing from the arterial catheter or other vascular line
Measured: From inclusion to Day 28
Time (min) spent by nurses and physicians (min) on these tasks
This outcome measure is planned to be collected during the first three days in a random sample of 10% of the study population and will be only considered during the medico-economic analyses.
Measured: During the first three days of the intensive care unit stay
Number of arterial and central venous catheter insertion during intensive care unit stay
Expressed as the incidence of new cases per 1000 catheter-days, including local and catheter-related bloodstream infections as consensually defined.
Measured: From inclusion to Day 28
Numbers of arterial and central venous catheter-related infections
Number of new cases per 1000 catheter-days
Measured: During intensive care unit stay
Numbers of local infections of arterial and central venous
Number of new cases per 1000 catheter-days
Measured: During intensive care unit stay
Numbers of arterial and central venous catheter-related bloodstream infections
Number of new cases per 1000 catheter-days
Measured: During intensive care unit stay
Number of bloodstream infections
Measured: During intensive care unit stay
Duration of intensive care unit stay
Measured: From inclusion to discharge
Duration of hospital stay
Measured: From inclusion to discharge
Intensive care unit mortality
Measured: From inclusion to discharge
Hospital mortality
Measured: From inclusion to discharge
Day 90 mortality
Measured: Day 90
Number of Adverse Events of special interest
Measured: From inclusion to Day 90
Incremental Cost-Effectiveness Ratio
Measured: At Day 28
Budget impact analysis of the generalization of the non-invasive strategy
The budget impact analysis will be to multiply the average annual cost per patient over 5 years by the number of eligible patients, taking into account a penetration rate
Measured: on a 5 years' time frame
Pain related to the device used for blood pressure monitoring
Numerical scale assessment of patient-reported pain related to the device used for blood pressure monitoring.
Using the following 11-point numerical scales, ranged from 0 (no pain) to 10 (very important and permanent pain).
Measured: Once a day, from inclusion to Day 28
Discomfort related to device used for blood pressure monitoring
Numerical scale assessment of patient-reported discomfort related to the device used for blood pressure monitoring Using the following 11-point numerical scales, ranged from 0 (no discomfort) to 10 (very important and permanent discomfort).
Measured: One a day, from inclusion to Day 28
Daily fluid balance of intakes and loss
Difference between the daily amounts of:
- daily fluid administration (in milliliter): intravenous hydration, vascular filling, enteral hydration
- and the daily fluid loss (in milliliter): urine and fluid removal (during renal replacement therapy), tube drainage, estimated blood loss (laboratory test, bleeding)
Measured: The first seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start15 Nov 2018
- Primary completion29 Nov 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Circulatory FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grégoire MULLER, Principal investigator, University of New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680963
- Sponsor's protocol ID
- DR180137
- Acronym
- EVERDAC
- Status last verified
- Apr 2025
- First submitted
- 11 Sep 2018
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muller G, Contou D, Ehrmann S, Martin M, Andreu P, Kamel T, Boissier F, Azais MA, Monnier A, Vimeux S, Chenal A, Nay MA, Salmon Gandonniere C, Lascarrou JB, Roudaut JB, Plantefeve G, Giraudeau B, Lakhal K, Tavernier E, Boulain T; CRICS-TRIGGERSEP F-CRIN Network and the EVERDAC Trial Group. Deferring Arterial Catheterization in Critically Ill Patients with Shock. N Engl J Med. 2025 Nov 13;393(19):1875-1888. doi: 10.1056/NEJMoa2502136. Epub 2025 Oct 29.
PubMed 41159885Muller G, Kamel T, Contou D, Ehrmann S, Martin M, Quenot JP, Lacherade JC, Boissier F, Monnier A, Vimeux S, Brunet Houdard S, Tavernier E, Boulain T. Early versus differed arterial catheterisation in critically ill patients with acute circulatory failure: a multicentre, open-label, pragmatic, randomised, non-inferiority controlled trial: the EVERDAC protocol. BMJ Open. 2021 Sep 14;11(9):e044719. doi: 10.1136/bmjopen-2020-044719.
PubMed 34521655
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Differed Arterial Catheterization in Critically Ill Patients With Acute Circulatory Failure: A Multicentre, Open-label, Pragmatic, Randomised, Non-inferiority Controlled Trial (EVERDAC Trial)
- ClinicalTrials.gov ID
- NCT03680963
- Acronym / sponsor ID
- EVERDAC / DR180137
- Conditions
- Acute Circulatory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,010 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 21 Sep 2018 (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 the present research is a combination of a one-sided test of non-inferiority and a one-sided test of superiority. A stepped approach will be used to evaluate these hypotheses:
- a less invasive intervention (i.e., no indwelling arterial catheter insertion until felt absolutely needed, according to consensual and predefined safety criteria) is non inferior to usual care (i.e., systematic indwelling arterial catheter insertion in the early hours of shock) in terms of mortality at day 28 (non-inferiority margin of 5%).
- a less invasive intervention is not only non-inferior but also superior to usual care in terms of mortality.
Multi-centre, pragmatic, randomised, controlled, open, two-parallel group, non-inferiority clinical trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-invasive strategy | Experimental | Procedure: Non-invasive strategyNon-invasive strategy consisting of blood pressure monitoring by non-invasive automated cuff measurements |
| Control strategy | Other | Procedure: Control strategyUsual strategy of systematic indwelling arterial catheter insertion in the early hours of acute circulatory failure |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years the day of inclusion
- Existence of an acute circulatory failure defined by the presence of the following items 1 and 2:
- Free express oral and informed consent of the patient or a proxy in case of impossibility for the patient to consent; emergency inclusion possible when legal representatives and patient's family are not available
- French health insurance holder
Key exclusion criteria (11 listed)
- Acute circulatory failure, as defined by items 1 and 2 in inclusion criteria list (cf. supra) present for more than 24 hours
- Non invasive blood pressure (NIBP) device fails to display a blood pressure value, or cuff placement impossible
- Patient for whom an Extra-Corporeal Membrane Oxygenation (ECMO) therapy (either veno-arterial or venous-venous) is already in place or is to be initiated within the next 6 hours
- Patient treated with vasopressor doses of more than 2.5 μg/kg/min of norepinephrine tartrate plus epinephrine for at least 2 hours (i.e., for instance, more than 8 mg of norepinephrine tartrate in 50 mL at the rate of 66 mL/hour for a patient weighing 70 kg) (please note that in fact this dosage corresponds to 1.25 μg/kg/min of norepinephrine base)
- Severe traumatic brain injury (i.e., traumatic brain injury with a Glasgow coma scale score of less than 9 before sedation)
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 |
|---|---|---|
| Non-invasive strategyNo indwelling arterial catheter insertion will be allowed during the first 28 days, excepted if predefined safety criteria (indicating absolute need of indwelling arterial catheter insertion) are reached. In the "non-invasive" group, automated oscillometric monitor will be used to monitor BP (blood pressure). | Procedure or surgery | Non-invasive strategy |
| Control strategyAn indwelling arterial catheter will be inserted as soon as possible (within the first four hours after randomization) and will be maintained except in case of indwelling arterial catheter futility, suspected or proven indwelling arterial catheter related infection or thrombosis (at discretion of attending physician) until day 28 or ICU (Intensive Care Unit) discharge (whichever comes first). After day 28, clinicians may choose to maintain or to remove indwelling arterial catheter. | Procedure or surgery | Control strategy |
Primary outcome
All-cause mortality by 28 days after randomisation
Time frame: Patients will be followed from randomization to day 28
36 secondary outcomes
To account for the potential bias brought by deaths occurring as the result of life-sustaining treatments withdrawal/withholding, as frequently encountered in intensive care unit, the investigators will record such events
Time frame: From inclusion to Day 35
Cumulative incidence of death
Time frame: From inclusion through Day 90
Cumulative survival free of indwelling arterial catheter insertion
Time frame: From inclusion through Day 90
Number of patients who underwent indwelling arterial catheter insertion, in both groups
Time frame: From randomization to Day 28
Evolution of daily Sequential Organ Failure Assessment (SOFA) score
Time frame: During the first seven days
Daily amount of intravenous fluid given for rapid vascular volume expansion
Time frame: From Day 1 to Day 7
Duration of mechanical ventilation
Time frame: From inclusion to Day 28
Ventilator-free days
Time frame: From Day 1 to Day 28
Proportion of patients treated by renal-replacement therapy
Time frame: Between Day 1 and Day 28
Renal replacement therapy-free days
Time frame: From Day 1 to Day 28
Proportion of patients treated by vasopressor
Time frame: Between Day 1 and Day 28
Vasopressor therapy-free days
Time frame: From Day 1 to Day 28
Mean daily blood volume drawn for lab testing during intensive care unit stay
Time frame: From inclusion to Day 28
Number of blood cultures performed during intensive care unit stay
Time frame: From inclusion to Day 28
Number of attempts at arterial puncture during intensive care unit stay
Time frame: From inclusion to Day 28
Evolution of blood haemoglobin level
Time frame: From Day 1 to Day 28
Evolution of haematocrit
Time frame: From Day 1 to Day 28
Number of red blood cell packs transfused
Time frame: From Day 1 to Day 28
Number of transcutaneous arterial and venous puncture for lab tests, arterial catheter insertion and set up of monitor, blood drawing from the arterial catheter or other vascular line
Time frame: From inclusion to Day 28
Time (min) spent by nurses and physicians (min) on these tasks
Time frame: During the first three days of the intensive care unit stay
Number of arterial and central venous catheter insertion during intensive care unit stay
Time frame: From inclusion to Day 28
Numbers of arterial and central venous catheter-related infections
Time frame: During intensive care unit stay
Numbers of local infections of arterial and central venous
Time frame: During intensive care unit stay
Numbers of arterial and central venous catheter-related bloodstream infections
Time frame: During intensive care unit stay
Number of bloodstream infections
Time frame: During intensive care unit stay
Duration of intensive care unit stay
Time frame: From inclusion to discharge
Duration of hospital stay
Time frame: From inclusion to discharge
Intensive care unit mortality
Time frame: From inclusion to discharge
Hospital mortality
Time frame: From inclusion to discharge
Day 90 mortality
Time frame: Day 90
Number of Adverse Events of special interest
Time frame: From inclusion to Day 90
Incremental Cost-Effectiveness Ratio
Time frame: At Day 28
Budget impact analysis of the generalization of the non-invasive strategy
Time frame: on a 5 years' time frame
Pain related to the device used for blood pressure monitoring
Time frame: Once a day, from inclusion to Day 28
Discomfort related to device used for blood pressure monitoring
Time frame: One a day, from inclusion to Day 28
Daily fluid balance of intakes and loss
Time frame: The first seven 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 22 Dec 2025.
- Results publication: PubMed 41159885Muller G, Contou D, Ehrmann S, Martin M, Andreu P, Kamel T, Boissier F, Azais MA, Monnier A, Vimeux S, Chenal A, Nay MA, Salmon Gandonniere C, Lascarrou JB, Roudaut JB, Plantefeve G, Giraudeau B, Lakhal K, Tavernier E, Boulain T; CRICS-TRIGGERSEP F-CRIN Network and the EVERDAC Trial Group. Deferring Arterial Catheterization in Critically Ill Patients with Shock. N Engl J Med. 2025 Nov 13;393(19):1875-1888. doi: 10.1056/NEJMoa2502136. Epub 2025 Oct 29.
- Derived from this study: PubMed 34521655Muller G, Kamel T, Contou D, Ehrmann S, Martin M, Quenot JP, Lacherade JC, Boissier F, Monnier A, Vimeux S, Brunet Houdard S, Tavernier E, Boulain T. Early versus differed arterial catheterisation in critically ill patients with acute circulatory failure: a multicentre, open-label, pragmatic, randomised, non-inferiority controlled trial: the EVERDAC protocol. BMJ Open. 2021 Sep 14;11(9):e044719. doi: 10.1136/bmjopen-2020-044719.
- Individual participant dataSharing planned: No
Related trials for Acute Circulatory Failure
Recruiting
Fluid Balance Guided by Modified Venous Excess Ultrasonography Versus Standard Care in Patients With Acute Kidney Injury Receiving Continuous Renal Replacement Therapy
AKI - Acute Kidney Injury, Fluid Balance
RecruitingObservational study
Prediction of Fluid Responsiveness Using the Femoral Vein-to-Artery Diameter Ratio
Fluid Responsiveness, Acute Circulatory Failure
RecruitingObservational study
Peripheral Tissue Perfusion in Intensive Care
Acute Circulatory Failure
Active, not recruitingObservational study
Concordance Study of Therapeutic Decision-making in Patients With Shock Based on Hemodynamic Monitoring
Shock, Acute Circulatory Failure
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.
Grégoire MULLER principal investigator
University of New Orleans
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive strategy in people with Acute Circulatory Failure, run by University Hospital, Tours at 9 sites in France.
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 11 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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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?
All-cause mortality by 28 days after randomisation (time frame: Patients will be followed from randomization to day 28). 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 NCT03680963, which also lists 2 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 22 Dec 2025; AzTrials last refreshed its copy on 2 Nov 2026.