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

Sponsor

Capital Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT02037815

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Edema	Drug: 20% mannitol solution, 125 ml, IV infusion in 15 min Drug: 3.1% sodium chloride solution, 125 ml, IV infusion in 15 min	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Official Title:

Correlation of Measured and Calculated Serum Osmolality During Mannitol or Hypertonic Saline Infusion in Patients After Craniotomy

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mannitol 20% mannitol solution, 125 ml, IV infusion in 15 min	Drug: 20% mannitol solution, 125 ml, IV infusion in 15 min
Experimental: Hypertonic saline 3.1% sodium chloride solution, 125 ml, IV infusion in 15 min	Drug: 3.1% sodium chloride solution, 125 ml, IV infusion in 15 min

Arm

Intervention/Treatment

Experimental: Mannitol

20% mannitol solution, 125 ml, IV infusion in 15 min

Drug: 20% mannitol solution, 125 ml, IV infusion in 15 min

Experimental: Hypertonic saline

3.1% sodium chloride solution, 125 ml, IV infusion in 15 min

Drug: 3.1% sodium chloride solution, 125 ml, IV infusion in 15 min

Outcome Measures

Primary Outcome Measures

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

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]