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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mannitol | Experimental | 20% mannitol solution, 125 ml, IV infusion in 15 min |
|
| Hypertonic saline | Experimental | 3.1% sodium chloride solution, 125 ml, IV infusion in 15 min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20% mannitol solution, 125 ml, IV infusion in 15 min | Drug |
| ||
| 3.1% sodium chloride solution, 125 ml, IV infusion in 15 min |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian-Xin Zhou, MD | Neurosurgical ICU, Beijing Tiantan Hospital, Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurosurgical ICU, Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26445777 | Derived | Li Q, Chen H, Hao JJ, Yin NN, Xu M, Zhou JX. Agreement of measured and calculated serum osmolality during the infusion of mannitol or hypertonic saline in patients after craniotomy: a prospective, double-blinded, randomised controlled trial. BMC Anesthesiol. 2015 Oct 7;15:138. doi: 10.1186/s12871-015-0119-4. | |
| 24760352 | Derived |
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| Drug |
|
| Li Q, Xu M, Zhou JX. Correlation of measured and calculated serum osmolality during mannitol or hypertonic saline infusion in patients after craniotomy: a study protocol and statistical analysis plan for a randomised controlled trial. BMJ Open. 2014 Apr 23;4(4):e004921. doi: 10.1136/bmjopen-2014-004921. |
| ID | Term |
|---|---|
| D001929 | Brain Edema |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D007262 | Infusions, Intravenous |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007263 | Infusions, Parenteral |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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