Hypertonic Saline vs. Mannitol for Elevated Intercranial Pressure
NCT01111682 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2013-03-05
Summary
This study examines the role of osmotic agents in controlling brain swelling in brain injured individuals. Two osmotic agents -- mannitol and hypertonic saline -- are in common use, and they will be compared in the context of a randomized clinical trial. The goal is to determine if these agent differ in their ability to control episodes of brain swelling.
Conditions
- Traumatic Brain Injury
- Elevated Intracranial Pressure
Interventions
- DRUG
-
Mannitol
0.9% normal saline infusion and boluses of mannitol
- DRUG
-
Hypertonic Saline
3% hypertonic saline continuous infusion, with intermittent boluses as needed
Sponsors & Collaborators
-
United States Department of Defense
collaborator FED -
University of Cincinnati
lead OTHER
Principal Investigators
-
Lori Shutter, MD · Department of Neurology College of Medicine University of Cincinnati
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-04-30
- Primary Completion
- 2010-11-30
- Completion
- 2010-11-30
Countries
- United States
Study Locations
More Related Trials
-
Hypernatremia for the Prevention and Treatment of Cerebral Edema in Traumatic Brain Injury
NCT01605357 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Mannitol vs HS to Treat ICHT After Severe TBI : Comparison on PtiO2 and Microdialysis Values
NCT01028339 ·Status: TERMINATED ·Phase: PHASE3
-
Coagulation Activation by Hyperosmolar Agents in Intracranial Hypertension
NCT03409237 ·Status: WITHDRAWN
-
Sodium Lactate Versus Hypertonic Saline Solution in the Treatment of Intracranial Hypertensive Episodes in Severe Brain Injured Patients
NCT06110429 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Correlation of Measured and Calculated Serum Osmolality During Hyperosmolar Drugs Infusion in Patients After Craniotomy
NCT02037815 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of Mannitol 20% Versus Hypertonic Saline 7.5% in Brain Metabolism and Oxygenation
NCT03573999 ·Status: COMPLETED ·Phase: PHASE4
-
Early Induced Hypernatremia for the Prevention and Management of Brain Edema
NCT02798601 ·Status: WITHDRAWN ·Phase: NA
-
Point of Care Optic Nerve Sheath Ultrasound to Assess Intracranial Pressure
NCT04686344 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients
NCT00125229 ·Status: TERMINATED
-
Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring
NCT00795587 ·Status: TERMINATED ·Phase: PHASE4
-
Multi-parameters'Change Process During Dehydration Therapy on Brain Edema Patients.
NCT03828032 ·Status: UNKNOWN ·Phase: NA
-
Osmotic Therapy for Patients With Severe Subarachnoid Hemorrhage
NCT05858060 ·Status: RECRUITING
-
Defining Volume Status with Extracellular Water Measurement in Patients with Intracranial Hemorrhage
NCT06590688 ·Status: NOT_YET_RECRUITING
-
Mannitol Brain Relaxation Effect
NCT02168075 ·Status: UNKNOWN ·Phase: NA
-
Saline Versus Balanced Crystalloid in Traumatic Brain Injury
NCT06953674 ·Status: RECRUITING ·Phase: PHASE3
-
Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
NCT00810940 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Hypertonic Saline as Therapy for Pediatric Concussion
NCT01612494 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Intensive Management of Pressure and Volume Expansion in Patients With Subarachnoid Hemorrhage
NCT01414894 ·Status: COMPLETED ·Phase: PHASE1
-
Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI)
NCT00316004 ·Status: TERMINATED ·Phase: PHASE3
-
Sodium-Lactate and Traumatic Brain Injury
NCT00319345 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Comparative Study Between Hydrocortisone and Mannitol in Treatment of Postdural Puncture Headache
NCT02760862 ·Status: COMPLETED ·Phase: PHASE4
-
Feasibility Trial of Traumatic Brain Injured Patients Randomized in the Prehospital Setting to Either Hypertonic Saline and Dextran Versus Normal Saline
NCT00878631 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
NCT03831997 ·Status: UNKNOWN
-
A Low ChloridE hyperTonic Solution for Brain Edema
NCT03204955 ·Status: COMPLETED ·Phase: PHASE1
-
Use of Salt-Water Solution to Improve Symptoms in Concussion
NCT00142090 ·Status: COMPLETED ·Phase: NA