ICU Patients Requiring Invasive Mechanical VentilationAWARENCT01617265
Study of a Strategy to Prevent Oversedation in Intensive Care Patients Under Mechanical Ventilation
A study testing Clinical Procedure to Prevent Oversedation and Usual sedation practice in people with ICU Patients Requiring Invasive Mechanical Ventilation, run by French Society for Intensive Care at 43 sites in France.
Trial summary
The purpose of the present study is to determine whether administration of sedation according to a strategy including a bundle of measures to prevent oversedation is associated with a reduction in mortality of intensive care unit patients requiring mechanical ventilation, compared to administration of sedation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Patients Requiring Invasive Mechanical Ventilation
- What is being tested?
- Clinical Procedure to Prevent Oversedation and Usual sedation practice
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,180 participants
- Where
- 43 sitesFrance
- Study dates
- Jun 2012to Jun 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and older
- Admission to ICU with expected mechanical ventilation duration > 48 hrs
- Mechanical ventilation in ICU for less than 12 hours
- Information provided to the patient or proxy
Who cannot join
- ICU Admission after cardiac arrest
- Acute or chronic neuromuscular disease
- Tracheotomy on ICU admission
- Acute cerebral injury with intracranial hypertension requiring continuous IV sedation with or without neuromuscular blockade
- Status epilepticus
- Treatment withdrawal decision
- Pregnancy, breast feeding
- Concurrent participation in another interventional study requiring a change in usual practice of sedation or mechanical ventilation
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
France43 sites
Hôpital Saint-Esprit
Agen, 47923
CHU d'Angers
Angers, 49000
Hopital Privé d'Antony
Antony, 92166
CH d'Argenteuil
Argenteuil, 95100
CH Germon et Gauthier
Beuvry, 62408
Hopital Avicenne
Bobigny, 93000
Hopital St-Andre
Bordeaux, 33075
Hopital Ambroise Pare
Boulogne-Billancourt, 92100
CHRU de la Cavale Blanche
Brest, 29609
Hopital Antoine Beclere
Clamart, 92140
CH Sud Francilien
Corbeil-Essones, 91106
CHU Henri Mondor
Créteil, 94010
Hopital Raymond Poincare
Garches, 92380
CHD Les Oudairies
La Roche-sur-Yon, 85925
CH de Versailles
Le Chesnay, 78157
CHU Kremlin-Bicetre
Le Kremelin-Bicetre, 94270
Hopital Roger Salengro
Lille, 59037
CH St-Joseph St-Luc
Lyon, 69000
Groupe Hospitalier Edouard Herriot
Lyon, 69437
CHU Marseille Hopital Nord
Marseille, 13015
Hopital de la Timone
Marseille, 13385
CH de Meaux
Meaux, 77104
Hopital Notre-Dame de Bon Secours
Metz, 57038
CH Princesse Grace
Monaco, 98012
GHIRM
Montfermeil, 93370
Hopital Laennec
Nantes, 44035
Hopital l'Archet
Nice, 06202
CHR d'Orléans Hopital la Source
Orléans, 45067
Hopital St Louis
Paris, 75010
Institut Mutualiste Montsouris
Paris, 75014
Hopital Tenon
Paris, 75020
CH Francois Miterrand
Pau, 64046
CH Poissy
Poissy, 78300
CH de Pontoise
Pontoise, 95303
CH de la Région d'Annecy
Pringy, 74374
CH Leon Binet
Provins, 77488
CH de St-Brieuc
Saint-Brieuc, 22027
Hopital Delafontaine
Saint-Denis, 93200
HIA Béjin
Saint-Mandé, 94160
CH de St-Malo
St-Malo, 35403
CHRU Bretonneau
Tours, 37044
Hopital Jean Bernard
Valenciennes, 59322
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Prevention of Oversedation in Intensive Care Patients Under Mechanical Ventilation : the AWARE Multicentric Randomized Trial
The purpose of the present study is to determine whether administration of sedation according to a strategy including a bundle of measures to prevent oversedation is associated with a reduction in mortality of intensive care unit patients requiring mechanical ventilation, compared to administration of sedation according to usual practices.
Read the detailed description
In intensive care unit (ICU) patients receiving mechanical ventilation (MV), potent hypnotics and morphinics are frequently administered to increase synchrony with the ventilator, control agitation and decrease discomfort and pain due to the tracheal tube, bed ridding, painful condition and diagnostic or therapeutic procedures.
However, administration sedatives or morphinics is often excessive and may result in deep and prolonged alteration of consciousness, delayed weaning from MV and prolonged MV. and exposes the patient to a higher risk of ventilator-associated pneumonia, ICU delirium and neuromuscular weakness at awakening.
The present randomized multicenter study will compare the day-90 mortality of a group of patients receiving conventional sedation to the mortality of a group of patients receiving sedation administered according to an algorithm aimed to prevent oversedation to the mortality. The algorithm is built on a graduate therapeutic response to increasingly intense symptoms of discomfort, pain, ventilator dyssynchrony and agitation, and includes the use of analgesics, non hypnotic benzodiazepines, neuroleptics, repeated intravenous (IV) boluses of hypnotics and short duration (6 hours) IV hypnotic infusions.
- Being tested
- Clinical Procedure to Prevent Oversedation, Usual sedation practice
- Keywords
- intensive care, mechanical ventilation, sedatives, morphinics, oversedation, mortality, midazolam, propofol, pain, agitation
- Medical subject headings
- Pain, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Procedure to Prevent OversedationProcedure or surgery
Sedation and analgesia will be administered according to a bundle of measures aimed at limiting oversedation, including repeated assessment of patients needs and graduate therapeutic response to control pain, discomfort, poor synchrony with the ventilator and agitation. The therapeutic options include non hypnotic anxiolytics, repeated IV hypnotics boluses, short-duration (6 hours) IV hypnotics infusion and round the clock IV hypnotics infusion.
Usual sedation practiceProcedure or surgery
Sedation and analgesia will be administered according to the usual practices in each participating center.
| Study group | Role | What they receive |
|---|---|---|
| Prevention of oversedation group | Experimental | In this arm sedation and analgesia will be administered according to a bundle of measures aimed at limiting oversedation, including repeated assessment of patients needs and graduate therapeutic response to control pain, discomfort, poor synchrony with the ventilator and agitation. The therapeutic options include non hypnotic anxiolytics, repeated intravenous (IV) hypnotics boluses, short-duration (6 hours) IV hypnotics infusion and round the clock IV hypnotics infusion. Receives: Procedure: Clinical Procedure to Prevent Oversedation |
| Conventional sedation group | Active comparator | In this arm, sedation will be administered according to the usual practices in each participating center. Receives: Procedure: Usual sedation practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day-90 mortality
Measured: Mortality at Day 90 after randomization
Secondary outcomes (14)
Mortality at Day 28
Measured: at day 28
Hospital mortality
Measured: at hospital discharge, up to day 90
1-yr mortality
Measured: at 1 yr
Mechanical ventilation duration
Measured: From onset of mechanical ventilation to day 28
Days alive with no mechanical ventilation
Measured: From ICU admission up to day 28
Occurence of ventilator-associated pneumonia
Measured: During mechanical ventilation duration, up to day 28
Use of non-invasive ventilation after extubation
Measured: From extubation to ICU discharge up to day 28
Duration of ICU stay
Measured: From ICU admission to ICU discharge or death in ICU, up to day 90
ICU confusion
Number of patients alive, awaken, and free of ICU-delirium assessed on the CAM-ICU
Measured: From Day 1 to 7, and at day 14, 21 and 28
Proximal muscle weakness
Number of patients alive, awaken, cooperative and free of proximal muscle weakness
Measured: from day 1 to 7, and at day 14, 21 and 28
Functional, cognitive and psychological status
Functional status (measured on the Barthel scale), depression (measured on the Hospital Anxiety \& Depression Scale), Posttraumatic stress disorder (measured on the Impact of Event Scale), Quality of Life (measured on the SF-36) and patient living location
Measured: At day 90 and 1 year
Time to weaning onset
Measured: Time from mechancial ventilation initiation to first spontaneous breathing trial, up to day 28
Number of patients requiring tracheotomy
Measured: During ICU stay, up to day 28
First sitting in chair
Measured: During ICU stay, up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for ICU Patients Requiring Invasive Mechanical VentilationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,180 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Society for Intensive Care
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Tours
- Responsible party
- Sponsor
- Investigators
- Bernard DE JONGHE, MD, Study chair, French Society of Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617265
- Sponsor's protocol ID
- SRLF-TG-1-AWARE
- Other IDs
- 2011-004246-18
- Acronym
- AWARE
- Status last verified
- Aug 2015
- First submitted
- 6 Jun 2012
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Payen JF, Chanques G, Mantz J, Hercule C, Auriant I, Leguillou JL, Binhas M, Genty C, Rolland C, Bosson JL. Current practices in sedation and analgesia for mechanically ventilated critically ill patients: a prospective multicenter patient-based study. Anesthesiology. 2007 Apr;106(4):687-95; quiz 891-2. doi: 10.1097/01.anes.0000264747.09017.da.
PubMed 17413906Kollef MH, Levy NT, Ahrens TS, Schaiff R, Prentice D, Sherman G. The use of continuous i.v. sedation is associated with prolongation of mechanical ventilation. Chest. 1998 Aug;114(2):541-8. doi: 10.1378/chest.114.2.541.
PubMed 9726743Constantin JM, Chanques G, De Jonghe B, Sanchez P, Mantz J, Payen JF, Sztark F, Richebe P, Lagneau F, Capdevila X, Bazin JE, Lefrant JY. [Current use of sedation and analgesia: 218 resuscitations in France services practices survey]. Ann Fr Anesth Reanim. 2010 May;29(5):339-46. doi: 10.1016/j.annfar.2010.01.014. Epub 2010 Apr 13. French.
PubMed 20392591Brook AD, Ahrens TS, Schaiff R, Prentice D, Sherman G, Shannon W, Kollef MH. Effect of a nursing-implemented sedation protocol on the duration of mechanical ventilation. Crit Care Med. 1999 Dec;27(12):2609-15. doi: 10.1097/00003246-199912000-00001.
PubMed 10628598De Jonghe B, Bastuji-Garin S, Fangio P, Lacherade JC, Jabot J, Appere-De-Vecchi C, Rocha N, Outin H. Sedation algorithm in critically ill patients without acute brain injury. Crit Care Med. 2005 Jan;33(1):120-7. doi: 10.1097/01.ccm.0000150268.04228.68.
PubMed 15644658Quenot JP, Ladoire S, Devoucoux F, Doise JM, Cailliod R, Cunin N, Aube H, Blettery B, Charles PE. Effect of a nurse-implemented sedation protocol on the incidence of ventilator-associated pneumonia. Crit Care Med. 2007 Sep;35(9):2031-6. doi: 10.1097/01.ccm.0000282733.83089.4d.
PubMed 17855817Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.
PubMed 10816184Strom T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet. 2010 Feb 6;375(9713):475-80. doi: 10.1016/S0140-6736(09)62072-9. Epub 2010 Jan 29.
PubMed 20116842Treggiari MM, Romand JA, Yanez ND, Deem SA, Goldberg J, Hudson L, Heidegger CP, Weiss NS. Randomized trial of light versus deep sedation on mental health after critical illness. Crit Care Med. 2009 Sep;37(9):2527-34. doi: 10.1097/CCM.0b013e3181a5689f.
PubMed 19602975Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
PubMed 15082703SRLF Trial Group. Impact of oversedation prevention in ventilated critically ill patients: a randomized trial-the AWARE study. Ann Intensive Care. 2018 Sep 21;8(1):93. doi: 10.1186/s13613-018-0425-3.
PubMed 30242747
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Oversedation in Intensive Care Patients Under Mechanical Ventilation : the AWARE Multicentric Randomized Trial
- ClinicalTrials.gov ID
- NCT01617265
- Acronym / sponsor ID
- AWARE / SRLF-TG-1-AWARE
- Keywords
- intensive care, mechanical ventilation, sedatives, morphinics, oversedation, mortality, midazolam, propofol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,180 participants (actual)
- Lead sponsor
- French Society for Intensive CareUniversity, hospital or other
- Collaborators
- University Hospital, Tours
- Study start
- Jun 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Jun 2012 (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 the present study is to determine whether administration of sedation according to a strategy including a bundle of measures to prevent oversedation is associated with a reduction in mortality of intensive care unit patients requiring mechanical ventilation, compared to administration of sedation according to usual practices.
Detailed description
In intensive care unit (ICU) patients receiving mechanical ventilation (MV), potent hypnotics and morphinics are frequently administered to increase synchrony with the ventilator, control agitation and decrease discomfort and pain due to the tracheal tube, bed ridding, painful condition and diagnostic or therapeutic procedures.
However, administration sedatives or morphinics is often excessive and may result in deep and prolonged alteration of consciousness, delayed weaning from MV and prolonged MV. and exposes the patient to a higher risk of ventilator-associated pneumonia, ICU delirium and neuromuscular weakness at awakening.
The present randomized multicenter study will compare the day-90 mortality of a group of patients receiving conventional sedation to the mortality of a group of patients receiving sedation administered according to an algorithm aimed to prevent oversedation to the mortality. The algorithm is built on a graduate therapeutic response to increasingly intense symptoms of discomfort, pain, ventilator dyssynchrony and agitation, and includes the use of analgesics, non hypnotic benzodiazepines, neuroleptics, repeated intravenous (IV) boluses of hypnotics and short duration (6 hours) IV hypnotic infusions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevention of oversedation group | Experimental | Procedure: Clinical Procedure to Prevent OversedationIn this arm sedation and analgesia will be administered according to a bundle of measures aimed at limiting oversedation, including repeated assessment of patients needs and graduate therapeutic response to control pain, discomfort, poor synchrony with the ventilator and agitation. The therapeutic options include non hypnotic anxiolytics, repeated intravenous (IV) hypnotics boluses, short-duration (6 hours) IV hypnotics infusion and round the clock IV hypnotics infusion. |
| Conventional sedation group | Active comparator | Procedure: Usual sedation practiceIn this arm, sedation will be administered according to the usual practices in each participating center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 and older
- Admission to ICU with expected mechanical ventilation duration > 48 hrs
- Mechanical ventilation in ICU for less than 12 hours
- Information provided to the patient or proxy
Key exclusion criteria (8 listed)
- ICU Admission after cardiac arrest
- Acute or chronic neuromuscular disease
- Tracheotomy on ICU admission
- Acute cerebral injury with intracranial hypertension requiring continuous IV sedation with or without neuromuscular blockade
- Status epilepticus
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 |
|---|---|---|
| Clinical Procedure to Prevent OversedationSedation and analgesia will be administered according to a bundle of measures aimed at limiting oversedation, including repeated assessment of patients needs and graduate therapeutic response to control pain, discomfort, poor synchrony with the ventilator and agitation. The therapeutic options include non hypnotic anxiolytics, repeated IV hypnotics boluses, short-duration (6 hours) IV hypnotics infusion and round the clock IV hypnotics infusion. | Procedure or surgery | Prevention of oversedation group |
| Usual sedation practiceSedation and analgesia will be administered according to the usual practices in each participating center. | Procedure or surgery | Conventional sedation group |
Primary outcome
Day-90 mortality
Time frame: Mortality at Day 90 after randomization
14 secondary outcomes
Mortality at Day 28
Time frame: at day 28
Hospital mortality
Time frame: at hospital discharge, up to day 90
1-yr mortality
Time frame: at 1 yr
Mechanical ventilation duration
Time frame: From onset of mechanical ventilation to day 28
Days alive with no mechanical ventilation
Time frame: From ICU admission up to day 28
Occurence of ventilator-associated pneumonia
Time frame: During mechanical ventilation duration, up to day 28
Use of non-invasive ventilation after extubation
Time frame: From extubation to ICU discharge up to day 28
Duration of ICU stay
Time frame: From ICU admission to ICU discharge or death in ICU, up to day 90
ICU confusion
Time frame: From Day 1 to 7, and at day 14, 21 and 28
Proximal muscle weakness
Time frame: from day 1 to 7, and at day 14, 21 and 28
Functional, cognitive and psychological status
Time frame: At day 90 and 1 year
Time to weaning onset
Time frame: Time from mechancial ventilation initiation to first spontaneous breathing trial, up to day 28
Number of patients requiring tracheotomy
Time frame: During ICU stay, up to day 28
First sitting in chair
Time frame: During ICU stay, up to day 28
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 26 Aug 2015.
- Background: PubMed 17413906Payen JF, Chanques G, Mantz J, Hercule C, Auriant I, Leguillou JL, Binhas M, Genty C, Rolland C, Bosson JL. Current practices in sedation and analgesia for mechanically ventilated critically ill patients: a prospective multicenter patient-based study. Anesthesiology. 2007 Apr;106(4):687-95; quiz 891-2. doi: 10.1097/01.anes.0000264747.09017.da.
- Background: PubMed 9726743Kollef MH, Levy NT, Ahrens TS, Schaiff R, Prentice D, Sherman G. The use of continuous i.v. sedation is associated with prolongation of mechanical ventilation. Chest. 1998 Aug;114(2):541-8. doi: 10.1378/chest.114.2.541.
- Background: PubMed 20392591Constantin JM, Chanques G, De Jonghe B, Sanchez P, Mantz J, Payen JF, Sztark F, Richebe P, Lagneau F, Capdevila X, Bazin JE, Lefrant JY. [Current use of sedation and analgesia: 218 resuscitations in France services practices survey]. Ann Fr Anesth Reanim. 2010 May;29(5):339-46. doi: 10.1016/j.annfar.2010.01.014. Epub 2010 Apr 13. French.
- Background: PubMed 10628598Brook AD, Ahrens TS, Schaiff R, Prentice D, Sherman G, Shannon W, Kollef MH. Effect of a nursing-implemented sedation protocol on the duration of mechanical ventilation. Crit Care Med. 1999 Dec;27(12):2609-15. doi: 10.1097/00003246-199912000-00001.
- Background: PubMed 15644658De Jonghe B, Bastuji-Garin S, Fangio P, Lacherade JC, Jabot J, Appere-De-Vecchi C, Rocha N, Outin H. Sedation algorithm in critically ill patients without acute brain injury. Crit Care Med. 2005 Jan;33(1):120-7. doi: 10.1097/01.ccm.0000150268.04228.68.
- Background: PubMed 17855817Quenot JP, Ladoire S, Devoucoux F, Doise JM, Cailliod R, Cunin N, Aube H, Blettery B, Charles PE. Effect of a nurse-implemented sedation protocol on the incidence of ventilator-associated pneumonia. Crit Care Med. 2007 Sep;35(9):2031-6. doi: 10.1097/01.ccm.0000282733.83089.4d.
- Background: PubMed 10816184Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.
- Background: PubMed 20116842Strom T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet. 2010 Feb 6;375(9713):475-80. doi: 10.1016/S0140-6736(09)62072-9. Epub 2010 Jan 29.
- Background: PubMed 19602975Treggiari MM, Romand JA, Yanez ND, Deem SA, Goldberg J, Hudson L, Heidegger CP, Weiss NS. Randomized trial of light versus deep sedation on mental health after critical illness. Crit Care Med. 2009 Sep;37(9):2527-34. doi: 10.1097/CCM.0b013e3181a5689f.
- Background: PubMed 15082703Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
- Derived from this study: PubMed 30242747SRLF Trial Group. Impact of oversedation prevention in ventilated critically ill patients: a randomized trial-the AWARE study. Ann Intensive Care. 2018 Sep 21;8(1):93. doi: 10.1186/s13613-018-0425-3.
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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.
Bernard DE JONGHE, MD study chair
French Society of Intensive Care
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Procedure to Prevent Oversedation and Usual sedation practice in people with ICU Patients Requiring Invasive Mechanical Ventilation, run by French Society for Intensive Care at 43 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 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 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?
Day-90 mortality (time frame: Mortality at Day 90 after randomization). 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 NCT01617265, which also lists 11 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 26 Aug 2015.