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

NCT00847977 | Terminated Phase 3

• 1 other identifier: BRD 08/3-J
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Head Trauma

Keywords

Acute head trauma

Outcome Measures

Primary Outcomes (1)

• Incidence of hyperchloremic acidosis during the 2 first days of acute cranial traumatism.

  J1 and J2

Secondary Outcomes (2)

• Incidence of hypokaliemia and hypocalcemia

  J1 and J2

• Study of treatment effect on the evolution of intracranil pressure.

  J1 and J2

Study Arms (2)

1

ACTIVE COMPARATOR

Heafusine - Physiologic serum

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

2

EXPERIMENTAL

Isofundine - Tetraspan

Drug: use of balanced crystalloids fluid and macromolecular fluid

Interventions

use of a non balced fluid and of a macromolecular fluid DRUG

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

Also known as: Physiological serum and HEAfusine

1

use of balanced crystalloids fluid and macromolecular fluid DRUG

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

Also known as: Tetraspan - Isofundine

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Service de Réanimation CHU de Nantes Boulevard Jean Monnet

Nantes, 44093, France

Location

Related Publications (1)

• Roquilly A, Loutrel O, Cinotti R, Rosenczweig E, Flet L, Mahe PJ, Dumont R, Marie Chupin A, Peneau C, Lejus C, Blanloeil Y, Volteau C, Asehnoune K. Balanced versus chloride-rich solutions for fluid resuscitation in brain-injured patients: a randomised double-blind pilot study. Crit Care. 2013 Apr 19;17(2):R77. doi: 10.1186/cc12686.

  PMID: 23601796 DERIVED

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2009
• First Posted: February 19, 2009
• Study Start: October 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 31, 2013

Record last verified: 2013-01

Locations

FR (1)