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

Brain Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02037815
• Other study ID #: KY-2013-002-003
• Status: Completed
• Phase: Phase 4
• First received: January 13, 2014
• Last updated: July 29, 2014
• Start date: January 2014
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Brain Edema

Intervention

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

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

Locations

Country	Name	City	State
China	Neurosurgical ICU, Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No