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Completed

NCT Number: NCT02130674

Optimized Therapy in Severe Traumatic Brain Injured Patients

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Coma Consciousness Disorders Craniocerebral Trauma Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Unconsciousness Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Zurich

Zurich, 8006, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dipeptiven

Drug

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

Other names: Dipeptamin

Primary outcomes

  1. 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

  2. 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

  1. cerebral lactate

    Time frame: 2 to 7 days

    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. cerebral lactate to pyruvate ratio

    Time frame: 2 to 7 days

    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

  3. cerebral glutamate

    Time frame: 2 to 7 days

    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

  4. intracranial pressure

    Time frame: 2 to 7 days

    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

  5. bispectral index electroencephalography

    Time frame: 2 to 7 days

    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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Fresenius Kabi
  • Swiss National Science Foundation
  • University Hospital, Zürich

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
May 5, 2014
Registry last updated
May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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