Optimized Therapy in Severe Traumatic Brain Injured Patients

Traumatic Brain Injury Clinical Trial

Official title:

Improvement of Therapy in Patients With Severe Traumatic Brain Injury: Differential Impact of Local and Systemic Changes and Routinely Applied Drugs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02130674
• Other study ID #: SNF 111782
• Secondary ID: SNF 111782
• Status: Completed
• Phase: Phase 4
• First received: April 26, 2014
• Last updated: May 4, 2014
• Start date: January 2005
• Est. completion date: February 2011

Study information

• Verified date: May 2014
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: SwissmedicSwitzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Coma
• Traumatic Brain Injury

Intervention

Drug:
• Dipeptiven
two groups: group 1: continuous infusion for 24 hours group 2: continuous infusion for 5 days

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (4)

Lead Sponsor	Collaborator
University of Zurich	Fresenius Kabi, Swiss National Science Foundation, University Hospital, Zürich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma glutamine levels	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	2 to 7 days	No
Primary	cerebral glutamine	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	2 to 7 days	No
Secondary	cerebral lactate	changes in cerebral lactate and lactate/pyruvate ratio reflecting cerebral energetic deficit during and after infusion of alanyl-glutamine compared to baseline and intra-infusion values expressed in absolute (millimole/ liter) or relative (%) values	2 to 7 days	Yes
Secondary	cerebral lactate to pyruvate ratio	changes in lactate/pyruvate ratio reflecting cerebral energetic deficit during and after infusion of alanyl-glutamine compared to baseline and intra-infusion values expressed in absolute (millimole/ liter) or relative (%) values	2 to 7 days	Yes
Secondary	cerebral glutamate	changes in cerebral glutamate reflecting cerebral energetic deficit during and after infusion of alanyl-glutamine compared to baseline and intra-infusion values expressed in absolute (micromole/ liter) or relative (%) values	2 to 7 days	Yes
Secondary	intracranial pressure	changes in intracranial pressure reflecting brain edema during and after infusion of alanyl-glutamine compared to baseline and intra-infusion values expressed in absolute (mm Hg) or relative (%) values	2 to 7 days	Yes
Secondary	bispectral index electroencephalography	changes in bispectral index EEG reflecting neuronal activation during and after infusion of alanyl-glutamine compared to baseline and intra-infusion values expressed in absolute or relative (%) values	2 to 7 days	Yes