Safety and Feasibility of Hypertonic Saline Solution After Aneurysmal Subarachnoid Hemorrhage: (HS3)
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|ClinicalTrials.gov Identifier: NCT02432157|
Recruitment Status : Unknown
Verified February 2016 by Thomas Jefferson University.
Recruitment status was: Recruiting
First Posted : May 4, 2015
Last Update Posted : February 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Subarachnoid Hemorrhage Cerebral Vasospasm Hyponatremia||Drug: HTS 3% Drug: Standard fluid management||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Hypertonic Saline Solution in Aneurysmal Subarachnoid Hemorrhage: A Randomized - Phase II Single Blinded Clinical Trial|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||January 2017|
Experimental: Hypertonic saline (HTS)
A protocol of prophylactic 3% HTS as a volume expander with bolus (over 30 minutes) of 3% HTS at a dose of 250 ml every 6 hours for 7 days. This will be given through a central line as soon as possible and within 72 hours of onset of SAH symptoms.
Drug: HTS 3%
3% HTS at a dose of 250 ml every 6 hours for 7 days
Active Comparator: Standard fluid
Routine fluid management strategy as pre-specified by our SAH management protocol at Jefferson University Hospital according to the American Heart Association and Neurocritical Care Guidelines for the management of SAH (this includes conventional intravenous fluids or normal saline solutions to maintain a normal hydration status and guided by the treating doctor and daily assessments of fluid balance).
Drug: Standard fluid management
Routine fluid management strategy as pre-specified by our SAH management protocol.
- Safety (adverse events) [ Time Frame: 21 days ]Incidence or proportion of serious adverse events
- Feasibility (Proportion of patients treated according to the protocol) [ Time Frame: 21 days ]Proportion of patients treated according to the protocol
- Vasospasm (Incidence of cerebral vasospasm defined as clinical deterioration) [ Time Frame: 21 days ]Incidence of cerebral vasospasm defined as clinical deterioration (focal deficit or decline in Glasgow Coma Scale (GCS) score of >/=2 points by neurological exam), or transcranial doppler (TCD) velocity increase with mean blood flow > 120 cm/sec, or arterial narrowing (mod-sec) on DSA or CTA.
- Hyponatremia (Incidence of hypovolemic hyponatremia defined as Na <135) [ Time Frame: 21 days ]Incidence of hypovolemic hyponatremia defined as Na <135
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432157
|Contact: Fred Rincon, MDfirstname.lastname@example.org|
|Contact: Jack Jallo, MD, PhDemail@example.com|
|United States, Pennsylvania|
|Thomas Jefferson University Hospital||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Jan Jager, RN 215-955-7301 Jan.Jager@jefferson.edu|
|Principal Investigator: Fred Rincon, MD, MSc|