Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Optimized Therapy in Severe Traumatic Brain Injured Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02130674
Recruitment Status : Completed
First Posted : May 5, 2014
Last Update Posted : May 6, 2014
Sponsor:
Collaborators:
Swiss National Science Foundation
Fresenius Kabi
University Hospital, Zürich
Information provided by (Responsible Party):
John Stover, University of Zurich

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.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Coma Drug: Dipeptiven Phase 4

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improvement of Therapy in Patients With Severe Traumatic Brain Injury: Differential Impact of Local and Systemic Changes and Routinely Applied Drugs
Study Start Date : January 2005
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: Dipeptiven
two groups: group 1: continuous infusion for 24 hours group 2: continuous infusion for 5 days
Other Name: Dipeptamin




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130674


Locations
Layout table for location information
Switzerland
University Hospital Zurich
Zurich, Switzerland, 8006
Sponsors and Collaborators
University of Zurich
Swiss National Science Foundation
Fresenius Kabi
University Hospital, Zürich
Investigators
Layout table for investigator information
Principal Investigator: John F Stover, MD University of Zurich

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: John Stover, Prof. Dr. med., University of Zurich
ClinicalTrials.gov Identifier: NCT02130674     History of Changes
Other Study ID Numbers: SNF 111782
SNF 111782 ( Other Grant/Funding Number: SNF 111782 )
First Posted: May 5, 2014    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014
Keywords provided by John Stover, University of Zurich:
traumatic brain injury
glutamine
microdialysis
metabolism
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System