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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)

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
  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
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

Resource links provided by NLM:


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 ]

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

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   (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
  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: NCT00847977

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

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
Study First Received: February 18, 2009
Last Updated: January 30, 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

ClinicalTrials.gov processed this record on August 17, 2017