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

Nantes University Hospital (NUH)

Status and phase: Terminated; Phase 3

Conditions: Head Trauma

Treatments: Drug: use of balanced crystalloids fluid and macromolecular fluid; Drug: use of a non balced fluid and of a macromolecular fluid

Study type: Interventional

Funder types: Other

Identifiers

NCT00847977

BRD 08/3-J

Details and patient eligibility

About

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.

Full description

Participation in the study lasts 7 days per patient.

Both solutions are crystalloids who received MA in France for ISOFUNDINE, MA in Germany with pending MA in France for TETRASPAN, including an indication for infusion. Both solutions are consistent with the recommendations of intensive care of a traumatized brain: iso-osmolar and without glucose. The study is an emergency: the resuscitation of a head injury, for which the plasma by crystalloids may be delayed.

J0: Day of Inclusion

On arrival at the emergency operating room at the diagnosis of a serious head injury alone, the anaesthetist that supports the patient in an initial phase includes the patient in the study.

A H0, it is holding the patient randomization and continued his rehabilitation with the lot of fluids allocated. If he wants to use macro-molecules, it may use HydroxyEhtylAmidons(HEA). Each batch assigned to a patient includes a crystalloids and HEA: witnesses arm includes saline solution and the HEAfusine while the interventional arm includes Isofundine and tetraspan. These treatment are indistinguishable and both provided by the laboratory Braun. They will be kept in operating emergency to be the most readily available, upon arrival of the patient. If the health of the patient requires a refill crystalloids emergency even before randomization did not take place, the clinician uses originally Saline and starts the protocol as soon as possible as soon as the patient him can take the few minutes needed to achieve inclusion. The first biological assessment include the determination of natremia, of kaliemia, of magnesemia, the ionized calcium, the lactatemia of albumin, the osmolarity of plasma and blood gases. These strengths are in Biological standard of care of a traumatized brain.

Apart from the contribution of crystalloids, the rest is therapeutic to the discretion of clinicians. The indication of monitoring the intra-cranial pressure sensor intra-parenchymatous is left to the discretion of the clinician without obligation associated with the study. As requires the usual care of this pathology, the patient is then transferred to intensive care.

J1 and J2

In accordance with the Memorandum of service, a basic daily infusion of crystalloids (30 ml / kg / day) is prescribed to all patients during the first 48 hours. The crystalloids used for these basic inputs is the lot assigned at inclusion.

If the indications of plasma referred to by hemodynamic boli solutes remain free indication of the doctor taking care of the patient, type of fluid used is the batch assigned to the patient (Isofundine-Physiologic serum), including the use of macromolecules that are available in the lot assigned to the patient (Heafusine-tetraspan).

Biological monitoring TBI usually based on a biological assessment every 12 hours. It includes a ionograms blood and blood gases. On the same samples without extract a larger volume of blood, we collect specifically in biological assessments:

• ionized calcium, magnesemia, natremia, kaliemia.
• lactatemia.
• albumin.
• plasma osmolarity. No blood gases.

Neurological based monitoring as requested by the clinician is changing the values of either the PIC transcranial doppler.

The contribution of treatment under study stops at the 48th hour, after that time, the inflow of fluid is pursued in accordance with the wishes of doctors, and the type of product is imposed by the study .

J7 or exit resuscitation

The end of the study is the 7th day of inclusion (not trauma), or the day of release resuscitation if it precedes the 7th day. This is the end of the collection of clinical data and biological weapons. From J2-J7, no treatment and no record is imposed by the study. This is a simple monitoring period assessing the future clinical neurological patients.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Glasgow < or equal to 8
• Patient > 18 years old

Exclusion criteria

• Polytraumatism
• Pregnancy
• Patient under guardianship
• renal insufficiency, hypokaliemia, hypocalcemia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

1

Active Comparator group

Description:

Heafusine - Physiologic serum

Treatment:

Drug: use of a non balced fluid and of a macromolecular fluid

2

Experimental group

Description:

Isofundine - Tetraspan

Treatment:

Drug: use of balanced crystalloids fluid and macromolecular fluid