Interest of Using Balanced Fluid for Infusion at the Early Phase of an Acute Cranial Trauma for Limiting Hyperchloremic Acidosis - Full Text View

Sponsored by:	Nantes University Hospital
Information provided by:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00847977

Purpose

isotonic NaCl serum is the first intent solution for infusion during the initial phase of reanimation for an acute cranial traumatism.

However, its use can trigger an hyperchloremic metabolic acidosis, what could be deleterious for the future of this patient.

Isofundine present all charateristics to be use in this indication: pharmacokinetic and pharmacodynamic similar to the physiologic serum, iso-osmolarity to plasma, no glucose provision and no interaction with hemostasis.

Condition	Intervention	Phase
Acute Head Trauma	Drug: use of a non balced fluid and of a macromolecular fluid Drug: use of balanced crystalloids fluid and macromolecular fluid	Phase III

MedlinePlus related topics: Injuries Wounds

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Intérêt d'Utiliser Des solutés de Remplissage équilibrés à la Phase précoce d'un Traumatisme crânien Grave Pour Limiter l'Acidose hyperchlorémique

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:

Incidence of hyperchloremic acidosis during the 2 first days of acute cranial traumatism. [ Time Frame: J1 and J2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of hypokaliemia and hypocalcemia [ Time Frame: J1 and J2 ] [ Designated as safety issue: No ]
Study of treatment effect on the evolution of intracranil pressure. [ Time Frame: J1 and J2 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	October 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Heafusine - Physiologic serum	Drug: use of a non balced fluid and of a macromolecular fluid Physiological serum: basic flow 30 ml/kg/j during 48 hoursand boli wished by physicians 20 ml/kg on 20 minutes Heafusine: boli 10 ml/kg on 20 minutes
2: Experimental Isofundine - Tetraspan	Drug: use of balanced crystalloids fluid and macromolecular fluid Isofundine: basic flow 30 ml/kg/j during 48 hoursand boli wished by physicians 20 ml/kg on 20 minutes Tetraspan: boli 10 ml/kg on 20 minutes

Show Detailed Description

Eligibility

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

Criteria

Inclusion Criteria:

Glasgow < or equal to 8
Patient > 18 years old

Exclusion Criteria:

Polytraumatism
Pregnancy
Patient under guardianship
renal insufficiency, hypokaliemia, hypocalcemia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847977

Locations

France
Service de Réanimation CHU de Nantes Boulevard Jean Monnet
Nantes, France, 44093

Sponsors and Collaborators

Nantes University Hospital

More Information

No publications provided

Responsible Party:	CHU de Nantes ( Cellule de Promotion de la Recherche Clinique )
Study ID Numbers:	BRD 08/3-J
Study First Received:	February 18, 2009
Last Updated:	February 18, 2009
ClinicalTrials.gov Identifier:	NCT00847977 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Craniocerebral Trauma
Wounds and Injuries
Disorders of Environmental Origin
Trauma, Nervous System
Acidosis

Additional relevant MeSH terms:

Craniocerebral Trauma
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin
Trauma, Nervous System

ClinicalTrials.gov processed this record on May 07, 2009