NCT01108744

Brief Summary

The study goal is to compare the management of increased intra-cranial pressure (ICP) using 3% hypertonic saline vs. mannitol (given in same osmolar loads). Primary hypothesis: 1\. Hypertonic saline will be non-inferior to mannitol in decreasing elevated ICP. Secondary hypotheses:

  1. 1.Hypertonic saline therapy will result with fewer complications than mannitol
  2. 2.ICP reduction duration will be longer using hypertonic saline when compared with mannitol

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2010

Completed
1.7 years until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

March 16, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

April 16, 2010

Last Update Submit

March 14, 2017

Conditions

Elevated Intracranial Pressure

Keywords

clinical trialmannitolintracranial pressure (ICP)hypertonic salinecerebral edematraumatic brain injury (TBI)

Outcome Measures

Primary Outcomes (1)

  • Percent reduction of ICP from baseline

    30 minutes from completion of medication administration

Secondary Outcomes (12)

  • Time from study drug administration completion to ICP < 25 mmHg

    First 72 hours

  • Cumulative duration of ICP below 25 mmHg

    First 24 hours

  • Cumulative duration of ICP below 25 mmHg

    First 72 hours

  • Cumulative duration of cerebral perfusion pressure (CPP) above 60 mmHg

    First 24 hours

  • Cumulative duration of cerebral perfusion pressure (CPP) above 60 mmHg

    First 72 hours

  • +7 more secondary outcomes

Study Arms (2)

hypertonic saline

ACTIVE COMPARATOR

3% hypertonic saline, dosed by ideal patient weight

Drug: hypertonic saline

Mannitol

ACTIVE COMPARATOR

20% mannitol, dosed by patient's ideal body weight

Drug: Mannitol

Interventions

hypertonic salineDRUG

3% hypertonic saline, dosed by ideal patient weight

hypertonic saline
MannitolDRUG

Mannitol 20% intravenous solution, dosed by patient's ideal body weight

Also known as: Osmitrol
Mannitol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • elevated ICP requiring ICP monitoring
  • ICP ≥ 25 mmHg 5 min after ICP bolt or EVD placement

You may not qualify if:

  • Requiring decompressive craniotomy or post decompressive craniotomy
  • Hyponatremia (sodium level \< 125 mEq/L)
  • Hypernatremia (sodium \> 155 mmol/L)
  • Serum osmolality ≤ 250 mOsm/kg
  • Serum osmolality ≥ 320 mOsm/kg
  • Physical exam compatible with brain death
  • Patients on hemodialysis with end-stage renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (7)

  • Shackford SR, Bourguignon PR, Wald SL, Rogers FB, Osler TM, Clark DE. Hypertonic saline resuscitation of patients with head injury: a prospective, randomized clinical trial. J Trauma. 1998 Jan;44(1):50-8. doi: 10.1097/00005373-199801000-00004.

    PMID: 9464749BACKGROUND

  • BARRY KG, BERMAN AR. Mannitol infusion. III. The acute effect of the intravenous infusion of mannitol on blood and plasma volumes. N Engl J Med. 1961 May 25;264:1085-8. doi: 10.1056/NEJM196105252642105. No abstract available.

    PMID: 13687351BACKGROUND

  • Brain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS; Bratton SL, Chestnut RM, Ghajar J, McConnell Hammond FF, Harris OA, Hartl R, Manley GT, Nemecek A, Newell DW, Rosenthal G, Schouten J, Shutter L, Timmons SD, Ullman JS, Videtta W, Wilberger JE, Wright DW. Guidelines for the management of severe traumatic brain injury. II. Hyperosmolar therapy. J Neurotrauma. 2007;24 Suppl 1:S14-20. doi: 10.1089/neu.2007.9994. No abstract available.

    PMID: 17511539BACKGROUND

  • The Brain Trauma Foundation. The American Association of Neurological Surgeons. The Joint Section on Neurotrauma and Critical Care. Use of mannitol. J Neurotrauma. 2000 Jun-Jul;17(6-7):521-5. doi: 10.1089/neu.2000.17.521.

    PMID: 10937895BACKGROUND

  • Bereczki D, Liu M, Prado GF, Fekete I. Cochrane report: A systematic review of mannitol therapy for acute ischemic stroke and cerebral parenchymal hemorrhage. Stroke. 2000 Nov;31(11):2719-22. doi: 10.1161/01.str.31.11.2719.

    PMID: 11062300BACKGROUND

  • Qureshi AI, Suarez JI, Bhardwaj A, Mirski M, Schnitzer MS, Hanley DF, Ulatowski JA. Use of hypertonic (3%) saline/acetate infusion in the treatment of cerebral edema: Effect on intracranial pressure and lateral displacement of the brain. Crit Care Med. 1998 Mar;26(3):440-6. doi: 10.1097/00003246-199803000-00011.

    PMID: 9504569BACKGROUND

  • Huang SJ, Chang L, Han YY, Lee YC, Tu YK. Efficacy and safety of hypertonic saline solutions in the treatment of severe head injury. Surg Neurol. 2006 Jun;65(6):539-46; discussion 546. doi: 10.1016/j.surneu.2005.11.019.

    PMID: 16720165BACKGROUND

MeSH Terms

Conditions

Intracranial HypertensionBrain EdemaBrain Injuries, Traumatic

Interventions

Saline Solution, HypertonicMannitol

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical PreparationsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Achikam Oren-Grinberg, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anaesthesia

Study Record Dates

First Submitted

April 16, 2010

First Posted

April 22, 2010

Study Start

January 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

March 16, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)