Optimized Therapy in Severe Traumatic Brain Injured Patients
NCT ID: NCT02130674
Last Updated: 2014-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
12 participants
INTERVENTIONAL
2005-01-31
2011-02-28
Brief Summary
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Contemporary therapeutic interventions are aimed at preventing and treating secondary damage. In this context, improved cerebral metabolism is an important target in modern neurointensive care.
The main hypothesis is that continuous intravenous infusion of glutamyl-alanyl dipeptide restores disturbed brain metabolism following severe traumatic brain injury.
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Detailed Description
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In two groups of patients the influence of different duration of infusion (group 1: 24 hours; group 2: 5 days) will be investigated. For this, pharmacokinetic and pharmacodynamic parameters in plasma and brain are determined.
Increased plasma glutamine and alanine in arterial and jugular venous plasma and in cerebral microdialysates are to reflect efficacy of Dipeptiven infusion.
Plasma glutamate levels as well as changes in cerebral glutamate, lactate, lactate/pyruvate ratio, intracranial pressure, bispectral index electroencephalography will be measured to exclude potential adverse effects
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dipeptiven
0.75 g/ kg/ d Dipeptiven ( L- alanine- L- glutamine; 82 mg/ ml L- alanine, 134.6 mg/ ml L- glutamine; Fresenius Kabi, Switzerland) continuous intravenous infusion
Dipeptiven
two groups: group 1: continuous infusion for 24 hours group 2: continuous infusion for 5 days
Interventions
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Dipeptiven
two groups: group 1: continuous infusion for 24 hours group 2: continuous infusion for 5 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* prolonged pharmacologic coma
* multimodal neuromonitoring (microdialysis, ptiO2)
* enteral nutrition
Exclusion Criteria
* abdominal injury
* mass transfusion
* renal impairment
* hepatic impairment
* barbiturate coma
* parenteral nutrition
* weight below 50 kg
* weight above 100 kg
18 Years
65 Years
ALL
No
Sponsors
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Swiss National Science Foundation
OTHER
Fresenius Kabi
INDUSTRY
University Hospital, Zürich
OTHER
University of Zurich
OTHER
Responsible Party
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John Stover
Prof. Dr. med.
Principal Investigators
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John F Stover, MD
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
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University Hospital Zurich
Zurich, , Switzerland
Countries
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References
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Nageli M, Fasshauer M, Sommerfeld J, Fendel A, Brandi G, Stover JF. Prolonged continuous intravenous infusion of the dipeptide L-alanine- L-glutamine significantly increases plasma glutamine and alanine without elevating brain glutamate in patients with severe traumatic brain injury. Crit Care. 2014 Jul 2;18(4):R139. doi: 10.1186/cc13962.
Other Identifiers
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SNF 111782
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SNF 111782
Identifier Type: -
Identifier Source: org_study_id
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