Brain Edema
Conditions
Keywords
hyperosmolar drugs, mannitol, hypertonic saline, serum osmolality, correlation
Brief summary
Osmotherapy has been used as the medical treatment for brain edema and intracranial hypertension in critically brain injured patients. Measurement of serum osmolality during osmotherapy is of clinical importance to determine clinical efficacy, adjust dosage and avoid side effect. Serum osmolality is often measured in laboratory by cryoscopic technique as the reference method. However, in clinical setting, routine measurement of serum osmolality is not feasible at bedside, either in intensive care unit (ICU) or neurosurgical ward. Therefore, clinicians usually estimate serum osmolality by using equations derived from serum osmoles that can be measured by bedside blood gas analysis or routine laboratory chemical analysis, such as sodium, potassium, urea, and glucose. In present study, mannitol or hypertonic saline will be used in patients after craniotomy, and serum osmolality will be measured before and during drug infusion. Investigators hypothesize that the correlation of measured and calculated serum osmolality is better during infusion of hypertonic saline than mannitol.
Interventions
DRUG20% mannitol solution, 125 ml, IV infusion in 15 min
DRUG3.1% sodium chloride solution, 125 ml, IV infusion in 15 min
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* adult patients after elective craniotomy, requiring hyperosmolar agents for prevention or treatment of brain edema
Exclusion criteria
* age younger than 18 yr or older than 65 yr * history of diabetes * unstable hemodynamic condition * presence of renal failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between the measured and calculated serum osmolality. | Immediately before the infusion of mannitol and hypertonic saline, and 15, 30, 60, 120, 240, and 360 minutes after the administration of the study drugs |
Secondary
| Measure | Time frame |
|---|---|
| Serum osmolality | Immediately before the infusion of mannitol and hypertonic saline, and 15, 30, 60, 120, 240, and 360 minutes after the administration of the study drugs |
| Concentration of serum sodium | Immediately before the infusion of mannitol and hypertonic saline, and 15, 30, 60, 120, 240, and 360 minutes after the administration of the study drugs |
Countries
China
Outcome results
None listed