WithdrawnNot Applicable

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

Stopped: Timeline to consent prior to intervention start was unfeasible.

United States0Started 2012-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent reduction of ICP from baseline

Timeframe: 30 minutes from completion of medication administration

Trial details

NCT IDNCT01108744

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-01

View on ClinicalTrials.gov More Elevated Intracranial Pressure trials