Mannitol Versus Hypertonic Saline Solution in the Treatment of Elevated Intracranial Pressure

NCT00447018 | Completed Phase 4

• 1 other identifier: 0224
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether mannitol is as effective as hypertonic saline solution in the treatment of elevated intracranial pressure in patients with brain injury.

Conditions

Intracranial Hypertension

Keywords

intracranial pressure; mannitol; hypertonic saline solution; brain injury; traumatic brain injury; Adult patients; With elevation of intracranial pressure (ICP > 20 mmHg)

Outcome Measures

Primary Outcomes (1)

• Magnitude of ICP and of cerebral perfusion pressure (CPP) changes following osmotherapy during a study period of 120 min.

Secondary Outcomes (3)

• Effects of treatment on blood flow velocities (FV) of middle cerebral artery using continuous transcranial doppler.

• Effects of treatment on brain oxygenation using brain tissue oxygen tension (PbrO2) probe.

• Effects of treatment on biochemical data (serum sodium and osmolality, urine output).

Interventions

20% mannitol DRUG

7.45% hypertonic saline solution DRUG

Eligibility Criteria

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

You may qualify if:

• age 18 or older
• sustained elevated intracranial pressure to more than 20 mmHg for more than 10 min
• mechanically ventilated in stable conditions for more than 2 hours prior to the study
• serum osmolality ranged between 280 and 320 mOsm/kg

You may not qualify if:

• imminent cranial or extracranial surgery
• leakage or drainage of cerebral spinal fluid
• unstable respiratory and hemodynamic conditions
• oliguric renal failure
• anemia
• use of mannitol or HSS in the previous 6 hours
• concomitant use of thiopentone

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Hopital Michallon

Grenoble, 38043, France

Location

Related Publications (2)

• Battison C, Andrews PJ, Graham C, Petty T. Randomized, controlled trial on the effect of a 20% mannitol solution and a 7.5% saline/6% dextran solution on increased intracranial pressure after brain injury. Crit Care Med. 2005 Jan;33(1):196-202; discussion 257-8. doi: 10.1097/01.ccm.0000150269.65485.a6.

  PMID: 15644669 RESULT

• Vialet R, Albanese J, Thomachot L, Antonini F, Bourgouin A, Alliez B, Martin C. Isovolume hypertonic solutes (sodium chloride or mannitol) in the treatment of refractory posttraumatic intracranial hypertension: 2 mL/kg 7.5% saline is more effective than 2 mL/kg 20% mannitol. Crit Care Med. 2003 Jun;31(6):1683-7. doi: 10.1097/01.CCM.0000063268.91710.DF.

  PMID: 12794404 RESULT

MeSH Terms

Conditions

Intracranial Hypertension; Brain Injuries; Brain Injuries, Traumatic

Interventions

Mannitol; Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jean-Francois Payen, MD, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 12, 2007
• First Posted: March 13, 2007
• Study Start: October 1, 2002
• Study Completion: June 1, 2005
• Last Updated: March 13, 2007

Record last verified: 2007-03

Locations

FR (1)