Optimized Therapy in Severe Traumatic Brain Injured Patients

University of Zurich (UZH)

Status and phase: Completed; Phase 4

Conditions: Traumatic Brain Injury; Coma

Treatments: Drug: Dipeptiven

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02130674

SNF 111782 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Dipeptiven

Experimental group

Description:

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

Treatment:

Drug: Dipeptiven