NCT02130674

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 5, 2014

Completed
Last Updated

May 6, 2014

Status Verified

May 1, 2014

Enrollment Period

6.1 years

First QC Date

April 26, 2014

Last Update Submit

May 4, 2014

Conditions

Traumatic Brain InjuryComa

Keywords

traumatic brain injuryglutaminemicrodialysismetabolism

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (5)

  • cerebral lactate

    2 to 7 days

  • cerebral lactate to pyruvate ratio

    2 to 7 days

  • cerebral glutamate

    2 to 7 days

  • intracranial pressure

    2 to 7 days

  • bispectral index electroencephalography

    2 to 7 days

Study Arms (1)

Dipeptiven

EXPERIMENTAL

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

Interventions

DipeptivenDRUG

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

Also known as: Dipeptamin
Dipeptiven

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • severe traumatic brain injury
  • prolonged pharmacologic coma
  • multimodal neuromonitoring (microdialysis, ptiO2)
  • enteral nutrition

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, 8006, Switzerland

Location

Related Publications (1)

  • Nageli M, Fasshauer M, Sommerfeld J, Fendel A, Brandi G, Stover JF. Prolonged continuous intravenous infusion of the dipeptide L-alanine- L-glutamine significantly increases plasma glutamine and alanine without elevating brain glutamate in patients with severe traumatic brain injury. Crit Care. 2014 Jul 2;18(4):R139. doi: 10.1186/cc13962.

    PMID: 24992948DERIVED

MeSH Terms

Conditions

Brain Injuries, TraumaticComa

Interventions

alanylglutamine

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John F Stover, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

April 26, 2014

First Posted

May 5, 2014

Study Start

January 1, 2005

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

May 6, 2014

Record last verified: 2014-05

Locations

CH(1)