Double Blind Study of Hypertonic Saline vs Mannitol in the Management of Increased Intracranial Pressure (ICP).

NCT ID: NCT01108744

Last Updated: 2017-03-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-01-31

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. Hypertonic saline therapy will result with fewer complications than mannitol

2. ICP reduction duration will be longer using hypertonic saline when compared with mannitol

Detailed Description

There is growing evidence in the literature indicating that ICP and Cerebral Perfusion Pressure measurements may not be sufficient in the management of elevated ICP. Based on this evidence, monitoring of partial brain tissue oxygenation has gain acceptance among neurosurgeons and neurointensivists, and has become a standard of care monitor in some centers across the country. There is, however, insufficient information in the literature describing the effects of hyperosmolar medications on regional brain tissue oxygenation.

We intend to undertake this non-inferiority, prospective, randomized double-blind study to answer very important clinical questions not yet answered in the literature: Will hypertonic saline therapy, given at equiosmolar load, be non-inferior to mannitol in reducing elevated ICP?

Conditions

Elevated Intracranial Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

hypertonic saline

3% hypertonic saline, dosed by ideal patient weight

Group Type: ACTIVE_COMPARATOR

hypertonic saline

Intervention Type: DRUG

3% hypertonic saline, dosed by ideal patient weight

Mannitol

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

Group Type: ACTIVE_COMPARATOR

Mannitol

Intervention Type: DRUG

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

Interventions

hypertonic saline

3% hypertonic saline, dosed by ideal patient weight

Intervention Type: DRUG

Mannitol

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

Intervention Type: DRUG

Other Intervention Names

Osmitrol

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Achikam Orin-Grinberg

Assistant Professor of Anaesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Achikam Oren-Grinberg, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 9464749 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 13687351 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17511539 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10937895 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11062300 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9504569 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16720165 (View on PubMed)

Other Identifiers

2009P000313

Identifier Type: -

Identifier Source: org_study_id