Improvement of Therapy in Patients With Severe Traumatic Brain Injury: Differential Impact of Local and Systemic Changes and Routinely Applied Drugs
Overview
- Phase
- Phase 4
- Intervention
- Dipeptiven
- Conditions
- Traumatic Brain Injury
- Sponsor
- University of Zurich
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- plasma glutamine levels
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Severe traumatic brain injury is associated with life-threatening and incapacitating secondary injury.
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.
Detailed Description
Patients suffering from severe traumatic brain injury and requiring multimodal neuromonitoring during pharmacological coma will receive alanyl-glutamine dipeptide (Dipeptiven) as part of standard clinical nutrition. 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
Investigators
John Stover
Prof. Dr. med.
University of Zurich
Eligibility Criteria
Inclusion Criteria
- •severe traumatic brain injury
- •prolonged pharmacologic coma
- •multimodal neuromonitoring (microdialysis, ptiO2)
- •enteral nutrition
Exclusion Criteria
- •patients anticipated to decease within 48 hours
- •abdominal injury
- •mass transfusion
- •renal impairment
- •hepatic impairment
- •barbiturate coma
- •parenteral nutrition
- •weight below 50 kg
- •weight above 100 kg
Arms & Interventions
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
Intervention: Dipeptiven
Outcomes
Primary Outcomes
plasma glutamine levels
Time Frame: 2 to 7 days
changes in plasma glutamine levels during and after infusion of alanyl-glutamine compared to baseline and intra-infusion values expressed in absolute (micromole/ liter) or relative (%) values
cerebral glutamine
Time Frame: 2 to 7 days
changes in cerebral glutamine levels during and after infusion of alanyl-glutamine compared to baseline and intra-infusion values expressed in absolute (micromole/ liter) or relative (%) values
Secondary Outcomes
- cerebral lactate to pyruvate ratio(2 to 7 days)
- intracranial pressure(2 to 7 days)
- bispectral index electroencephalography(2 to 7 days)
- cerebral lactate(2 to 7 days)
- cerebral glutamate(2 to 7 days)