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

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ClinicalTrials.gov Identifier: NCT00847977
Recruitment Status : Terminated
First Posted : February 19, 2009
Last Update Posted : January 31, 2013
Sponsor:
Information provided by:
Nantes University Hospital

Brief Summary:

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 or disease Intervention/treatment 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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

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U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Incidence of hyperchloremic acidosis during the 2 first days of acute cranial traumatism. [ Time Frame: J1 and J2 ]

Secondary Outcome Measures :
  1. Incidence of hypokaliemia and hypocalcemia [ Time Frame: J1 and J2 ]
  2. Study of treatment effect on the evolution of intracranil pressure. [ Time Frame: J1 and J2 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847977


Locations
France
Service de Réanimation CHU de Nantes Boulevard Jean Monnet
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013

Keywords provided by Nantes University Hospital:
Acute head trauma

Additional relevant MeSH terms:
Wounds and Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases