Continuous Hyperosomolar Therapy for Traumatic Brain-injured Patients
NCT ID: NCT03143751
Last Updated: 2020-12-08
Study Results
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Basic Information
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COMPLETED
PHASE3
370 participants
INTERVENTIONAL
2017-10-31
2020-03-05
Brief Summary
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The COBI trial is the first randomized controlled trial powered to investigate whether continuous hyperosmolar therapy in TBI patients improve long term recovery.
Hypothesis
Patients treated with early continuous hyperosmolar therapy have reduced morbidity and mortality rates compared to those receiving standard care alone after traumatic brain injury.
Research Questions
1. Does early continuous hyperosmolar therapy reduce morbidity and mortality rates at 3 and 6 months after TBI assessed by the GOSE questionnaire?
2. Does early continuous hyperosmolar therapy prevent intracranial hypertension?
Detailed Description
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Continuous infusion of hyperosmolar therapy has been proposed for the prevention or the treatment of ICH. Whether an early administration of continuous hyperosmolar therapy improves long term outcomes is uncertain. The aim of the current study is to assess the efficiency and the safety of continuous hyperosmolar therapy in TBI patients.
Methods The COBI (Continuous hyperosmolar therapy in traumatic brain-injured patients) trial is a multicenter, randomized, controlled, open-label, two-arms study with blinded adjudication of primary outcome. Three hundred and seventy patients hospitalized in Intensive Care Unit with a traumatic brain injury (Glasgow Coma Scale ≤ 12 and abnormal brain CT-scan) are randomized in the first 24 hours following trauma to standard care or continuous hyperosmolar therapy (NaCl 20%) plus standard care. Continuous hyperosmolar therapy is maintained for at least 48 hours in the treatment group and continued for as long as is necessary to prevent intracranial hypertension. The primary outcome is the score on the Extended Glasgow Outcome Scale (GOS-E) at 6 months. The treatment effect is estimated with ordinal logistic regression adjusted for pre-specified prognostic factors and expressed as a common odds ratio.
Discussion The COBI trial is the first randomized controlled trial powered to investigate whether continuous hyperosmolar therapy in TBI patients improve long term recovery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Continuous hyperosmolar therapy
Standard cares plus continuous hyperosmolar therapy (NaCl20%)
NaCl20% (Continuous hyperosmolar therapy)
Early intravenous administration (\<24 hours after traumatic brain injury) of NaCl20% for a minimal duration of 48 hours (continued for as long as is necessary to prevent intracranial hypertension)
1-hour bolus (15 g if Na+ \< 145 mmol/L; 7.5 g if 145 \< Na+ \< 150 mmol/L; or no bolus) followed by 1 g/hour as long as Na+\< 150 mmol/L, reduced to 0.5 g/L if 150 \< Na+ \< 155 mmol/L, Discontinuation when 155 mmol/L\<Na+
Control
Standard cares alone.
No interventions assigned to this group
Interventions
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NaCl20% (Continuous hyperosmolar therapy)
Early intravenous administration (\<24 hours after traumatic brain injury) of NaCl20% for a minimal duration of 48 hours (continued for as long as is necessary to prevent intracranial hypertension)
1-hour bolus (15 g if Na+ \< 145 mmol/L; 7.5 g if 145 \< Na+ \< 150 mmol/L; or no bolus) followed by 1 g/hour as long as Na+\< 150 mmol/L, reduced to 0.5 g/L if 150 \< Na+ \< 155 mmol/L, Discontinuation when 155 mmol/L\<Na+
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe traumatic brain injury defined as the association of a Coma Glasgow Scale ≤ 12 together with a traumatic abnormal brain CT-scan
* Time to inclusion inferior to 24 hours
* Informed consent (or emergency procedure)
Exclusion Criteria
* Coma Glasgow Scale of 3 and fixed dilated pupils
* associated cervical spine injury
* imminent death and do-not-resuscitate orders
* pregnancy.
* Major not legally responsible
* Oedemato-ascitic decompensation of hepatic cirrhosis
* State of hydro-sodium retention secondary to heart failure
18 Years
80 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Olivier Huet, PU-PH
Role: PRINCIPAL_INVESTIGATOR
CHU de Brest
Lasocki Sigismond, PU-PH
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Angers
Thomas Geerraerts, PU-PH
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Francis Remerand, PU-PH
Role: PRINCIPAL_INVESTIGATOR
CHU de Tours
Philippe Seguin, PU-PH
Role: PRINCIPAL_INVESTIGATOR
Rennes University Hospital
Claire Dahyot, PU-PH
Role: PRINCIPAL_INVESTIGATOR
CHU Poitiers
Pierre François Perrigault, PU-PH
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Jean Denis Moyer, PU-PH
Role: PRINCIPAL_INVESTIGATOR
AP-HP Beaujon
Tarek SHARSHAR, PU-PH
Role: PRINCIPAL_INVESTIGATOR
AP-HP Saint-Anne
Locations
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CHU Angers
Angers, , France
CHU Brest Hopital La Cavale Blanche
Brest, , France
AP-HP Beaujon
Clichy, , France
CHU Montpellier
Montpellier, , France
CHU de Nantes
Nantes, , France
Centre Hospitalier Sainte-Anne
Paris, , France
CHU Poitiers
Poitiers, , France
CHU Rennes-Hopital Pontchaillou
Rennes, , France
CHU Toulouse Hôpital Pierre-Paul Riquet
Toulouse, , France
CHU Tours
Tours, , France
Countries
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References
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Huet O, Chapalain X, Vermeersch V, Moyer JD, Lasocki S, Cohen B, Dahyot-Fizelier C, Chalard K, Seguin P, Hourmant Y, Asehnoune K, Roquilly A; Atlanrea Study Group and the Societe Francaise d'Anesthesie Reanimation (SFAR) Research Network. Impact of continuous hypertonic (NaCl 20%) saline solution on renal outcomes after traumatic brain injury (TBI): a post hoc analysis of the COBI trial. Crit Care. 2023 Jan 27;27(1):42. doi: 10.1186/s13054-023-04311-1.
Roquilly A, Moyer JD, Huet O, Lasocki S, Cohen B, Dahyot-Fizelier C, Chalard K, Seguin P, Jeantrelle C, Vermeersch V, Gaillard T, Cinotti R, Demeure Dit Latte D, Mahe PJ, Vourc'h M, Martin FP, Chopin A, Lerebourg C, Flet L, Chiffoleau A, Feuillet F, Asehnoune K; Atlanrea Study Group and the Societe Francaise d'Anesthesie Reanimation (SFAR) Research Network. Effect of Continuous Infusion of Hypertonic Saline vs Standard Care on 6-Month Neurological Outcomes in Patients With Traumatic Brain Injury: The COBI Randomized Clinical Trial. JAMA. 2021 May 25;325(20):2056-2066. doi: 10.1001/jama.2021.5561.
Roquilly A, Lasocki S, Moyer JD, Huet O, Perrigault PF, Dahyot-Fizelier C, Seguin P, Sharshar T, Geeraerts T, Remerand F, Feuillet F, Asehnoune K; COBI group. COBI (COntinuous hyperosmolar therapy for traumatic Brain-Injured patients) trial protocol: a multicentre randomised open-label trial with blinded adjudication of primary outcome. BMJ Open. 2017 Sep 24;7(9):e018035. doi: 10.1136/bmjopen-2017-018035.
Other Identifiers
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RC16_0474
Identifier Type: -
Identifier Source: org_study_id