Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT00930202
Eligibility Criteria:
Inclusion Criteria:
* 18 years old or greater
* Initial diagnosis of an isolated, severe traumatic brain injury (Glasgow Coma Score of 8 or less upon initial evaluation)
* Cerebral edema with a head CT and Marshall classification of diffuse injury type II, III, or IV.
* Primary care team orders to raise blood sodium by 10 mEq/L from baseline.
* Placement of an intraparenchymal fiberoptic monitor to monitor intracranial pressure (ICP).
Exclusion Criteria:
* Age \< 18 years
* Signs of hypovolemia including systolic BP \< 90 mmHg
* Signs of liver disease including jaundice and ascites
* AST \> 35 units/L
* ALT \> 35 units/L
* Signs of renal disease including history of dialysis
* Serum creatinine \> 1.5 mg/dL
* BUN \> 20 mg/dL range
* Baseline serum sodium \>/= 145 mEq/L
* Pregnant or lactating females
* Concomitant use of digoxin, ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, simvastatin and lovastatin
* Presentation to the tertiary care hospital \> 24 hours post-injury
* Multi-system traumatic injuries
* Diabetes Insipidus
* Anticipation of diagnosis compatible with brain death, or no expectation of survival with 48 hours.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00930202
Study Brief:
Protocol Section:
NCT00930202