Mannitol vs HS to Treat ICHT After Severe TBI : Comparison on PtiO2 and Microdialysis Values

This study has been terminated.
(No patients enrolled during 2 years)
Sponsor:
Information provided by (Responsible Party):
BORET Henry, Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier:
NCT01028339
First received: December 3, 2009
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to determine whether hypertonic saline is as much effective as mannitol to treat intracranial hypertension after traumatic brain injury and has at least the same effects on PtiO2 and cerebral metabolism studied through microdialysis.


Condition Intervention Phase
Traumatic Brain Injury
Drug: Hypertonic saline
Drug: Mannitol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Mannitol Versus Hypertonic Saline to Treat Intracranial Hypertension After Severe Traumatic Brain Injury : a Comparative Study on the Effects on PtiO2 and Microdialysis Values

Resource links provided by NLM:


Further study details as provided by Direction Centrale du Service de Santé des Armées:

Primary Outcome Measures:
  • Effects of HS versus mannitol on lactate/pyruvate ratio [ Time Frame: 20 min, 40 min, H1, H2, H3 and H4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Metabolic profile evaluated thanks to measure of lactate/pyruvate ratio and cerebral glucose [ Time Frame: 20 min, 40 min, H1, H2, H3 and H4 ] [ Designated as safety issue: No ]
  • Duration of PtiO2 > 15 mm Hg if PtiO2 was < 15 mm Hg before osmotherapy [ Time Frame: 20 min, 40 min, H1, H2, H3 et H4 ] [ Designated as safety issue: No ]
  • Duration of ICP<20 mm Hg after osmotherapy [ Time Frame: 20 min, 40 min, H1, H2, H3 and H4 ] [ Designated as safety issue: No ]
  • Interstitial osmolarity [ Time Frame: 20 min, 40 min and H1 ] [ Designated as safety issue: No ]
  • Necessity of a third line therapy (hypothermia, craniectomy, propofol/barbiturate coma [ Time Frame: Day after osmotherapy ] [ Designated as safety issue: No ]
  • Length of stay [ Time Frame: After leaving the unit ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 28th days ] [ Designated as safety issue: No ]
  • Glasgow outcome scale [ Time Frame: 6th month ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: July 2008
Estimated Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mannitol Drug: Mannitol
Mannitol
Experimental: Hypertonic saline Drug: Hypertonic saline
2 mL/kg of 7.5% hypertonic saline associated to hydroxyethyl starch

Detailed Description:

Mannitol is frequently used to treat intracranial hypertension after TBI. However, it can be deleterious, particularly through hyperdiuresis and risks of hypovolemia. It also needs volume compensation and induces logistical problem because of needs of high infused volume to achieve osmolar load and avoid hypotension. Finally, some recent studies tend to prove superiority of hypertonic saline versus mannitol on the prognosis of TBI. especially through modulation of inflammatory reactions mechanisms and apoptosis.

We would like to prove non inferiority of hypertonic saline versus mannitol after TBI to allow its large utilization, especially by field military doctors with specific logistical problems. For that, more than the single Intracranial Pressure, we want to study effects of HS vs mannitol not only on PtiO2 but also on cerebral microdialysis which gives informations on focal metabolism with profiles of ischemia, metabolic crisis, hyperglycolysis (possible reflect of neuronal restoration) and normality.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe Traumatic brain injury monitored with ICP, PtiO2 and cerebral microdialysis
  • And ICP> 20 mm Hg needing osmotherapy
  • And approval of the next of kind

Exclusion Criteria:

  • Bilateral fixed dilated pupils
  • Contra-indication to multimodal neuromonitoring
  • Previous CNS disease
  • Contra-indication to HS (cardiac insufficiency,...)
  • Natremia > 155 mmol/L or osmolarity > 320 mOsm/L
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028339

Locations
France
HIA Sainte Anne
Toulon, France, 83130
Sponsors and Collaborators
Direction Centrale du Service de Santé des Armées
Investigators
Principal Investigator: Henry BORET, MD Direction Centrale du Service de Santé des Armées
  More Information

Publications:
Responsible Party: BORET Henry, Médecin en chef, Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier: NCT01028339     History of Changes
Other Study ID Numbers: SSH versus mannitol
Study First Received: December 3, 2009
Last Updated: August 7, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Direction Centrale du Service de Santé des Armées:
traumatic brain injury
PtiO2
Cerebral microdialysis
Osmotherapy
hypertonic saline
mannitol

Additional relevant MeSH terms:
Intracranial Hypertension
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014