Mannitol vs HS to Treat ICHT After Severe TBI : Compariso... | NCT01028339

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

NCT01028339

Sponsor

Direction Centrale du Service de Santé des Armées

Status

Terminated

Last Update Posted

Aug 8, 2012Estimated

Enrollment

30Actual

Phase

Phase 3

Conditions

Traumatic Brain Injury

Interventions

Hypertonic saline
Mannitol

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No patients enrolled during 2 years

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Jun 2012Actual

Completion Date

Dec 2012Estimated

First Submitted Date

Dec 3, 2009

First Submission Date that Met QC Criteria

Dec 8, 2009

First Posted Date

Dec 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2012

Last Update Posted Date

Aug 8, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

BORET Henry, Médecin en chef, Direction Centrale du Service de Santé des ArméesPrincipal Investigator

Lead Sponsor

Direction Centrale du Service de Santé des ArméesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mannitol	Active Comparator		Drug: Mannitol
Hypertonic saline	Experimental		Drug: Hypertonic saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hypertonic saline	Drug	2 mL/kg of 7.5% hypertonic saline associated to hydroxyethyl starch	Hypertonic saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effects of HS versus mannitol on lactate/pyruvate ratio		20 min, 40 min, H1, H2, H3 and H4

Secondary Outcomes

Measure	Description	Time Frame
Metabolic profile evaluated thanks to measure of lactate/pyruvate ratio and cerebral glucose		20 min, 40 min, H1, H2, H3 and H4
Duration of PtiO2 > 15 mm Hg if PtiO2 was < 15 mm Hg before osmotherapy		20 min, 40 min, H1, H2, H3 et H4

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henry BORET, MD	Direction Centrale du Service de Santé des Armées	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HIA Sainte Anne		Toulon		83130	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12794404	Background	Vialet R, Albanese J, Thomachot L, Antonini F, Bourgouin A, Alliez B, Martin C. Isovolume hypertonic solutes (sodium chloride or mannitol) in the treatment of refractory posttraumatic intracranial hypertension: 2 mL/kg 7.5% saline is more effective than 2 mL/kg 20% mannitol. Crit Care Med. 2003 Jun;31(6):1683-7. doi: 10.1097/01.CCM.0000063268.91710.DF.
17297315

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D006982	Hypertonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D013402	Sugar Alcohols

ID	Term
D012462	Saline Solution, Hypertonic
D008353	Mannitol