Text Size

Interest of Using Balanced Fluid for Infusion at the Early Phase of an Acute Cranial Trauma for Limiting Hyperchloremic Acidosis (IsoTC)

This study has been terminated.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00847977
First received: February 18, 2009
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  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
Head Trauma
 Drug: use of a non balced fluid and of a macromolecular fluid
Drug: use of balanced crystalloids fluid and macromolecular fluid
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 42
Study Start Date: October 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Other Name: Physiological serum and HEAfusine
Experimental: 2
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
Other Name: Tetraspan - Isofundine

  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: Cellule de Promotion de la Recherche Clinique, CHU de Nantes
ClinicalTrials.gov Identifier: NCT00847977     History of Changes
Other Study ID Numbers: BRD 08/3-J
Study First Received: February 18, 2009
Last Updated: January 30, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Acute head trauma

Additional relevant MeSH terms:
Acidosis
Craniocerebral Trauma
Wounds and Injuries
Acid-Base Imbalance
 Metabolic Diseases
Trauma, Nervous System
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013