Increased Intracranial Pressure
Conditions
Brief summary
The overall purpose of this study is to compare the effects of mannitol and hypertonic saline on patients with increased intracranial pressure. The hypothesis being tested is that hypertonic saline is more effective in controlling increased intracranial pressure than mannitol.
Interventions
DRUGHypertonic Saline, Mannitol
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented SAH (by computed tomography or lumbar puncture), ICH, TBI or brain tumor * Patient greater than or equal to 18 years of age * ICP monitor in place * ICP greater than 20mmHg, not related to a transient noxious stimulus and not responding to standard measures for controlling ICP (ventricular drainage, elevation of head of the bed and optimizing PaCO2) * Patient or patient's legally authorized representative has provided written informed consent
Exclusion criteria
* Patient less than 18 years of age * Lack of ICP monitoring * Patient received Mannitol prior to placement of ICP monitor * Baseline serum osmolarity of greater than 310 mOsm/L * Patient is currently enrolled in another investigational drug or device study * Congestive heart failure at time of enrollment * Chronic renal failure on hemodialysis * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of ICP below treatment threshold (less than 20 mmHg) | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare effects of each treatment on MAP, CPP, serum and urine sodium and osmolality | — |
Outcome results
None listed