Correlation of Measured and Calculated Serum Osmolality During Hyperosmolar Drugs Infusion in Patients After Craniotomy

Phase 4

Completed

• Conditions: Brain Edema
• Interventions: Drug: 20% mannitol solution, 125 ml, IV infusion in 15 min; Drug: 3.1% sodium chloride solution, 125 ml, IV infusion in 15 min

• Registration Number: NCT02037815
• Lead Sponsor: Capital Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-16
• Primary Completion: 2014-04
• Study Completion: 2014-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-29
• Last Update Posted: 2014-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mannitol	20% mannitol solution, 125 ml, IV infusion in 15 min	20% mannitol solution, 125 ml, IV infusion in 15 min
Hypertonic saline	3.1% sodium chloride solution, 125 ml, IV infusion in 15 min	3.1% sodium chloride solution, 125 ml, IV infusion in 15 min

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Neurosurgical ICU, Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China