NCT00847977: IsoTC

Intérêt d'Utiliser Des solutés de Remplissage équilibrés à la Phase précoce d'un Traumatisme crânien Grave Pour Limiter l'Acidose hyperchlorémique

Terminated Phase 3 Last updated 30 January 2013

What this trial tests

Phase 3 trial testing use of a non balced fluid and of a macromolecular fluid in Head Trauma in 42 participants. Terminated before completion.

Timeline

1 October 2008

Primary endpoint
1 October 2010

1 October 2010

Quick facts

Lead sponsor	Nantes University Hospital
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	42
Start date	1 October 2008
Primary completion	1 October 2010
Estimated completion	1 October 2010
Sites	1 location across France

Drugs / interventions tested

• use of a non balced fluid and of a macromolecular fluid — full drug profile →
• use of balanced crystalloids fluid and macromolecular fluid — full drug profile →

Conditions studied

• Head Trauma — all drugs for Head Trauma →

Sponsor

Nantes University Hospital

Who can join

18 and older, any sex, with Head Trauma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of hyperchloremic acidosis during the 2 first days of acute cranial traumatism.
  Time frame: J1 and J2

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Balanced versus chloride-rich solutions for fluid resuscitation in brain-injured patients: a randomised double-blind pilot study.
   Roquilly A, Loutrel O, Cinotti R, Rosenczweig E, et al · · 2013 · cited 55× · PMID 23601796 · DOI 10.1186/cc12686