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

NCT ID: NCT02037815

Last Updated: 2014-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-06-30

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.

Conditions

Brain Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: QUADRUPLE

Study Groups

Mannitol

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Hypertonic saline

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jian-Xin Zhou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian-Xin Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

Neurosurgical ICU, Beijing Tiantan Hospital, Capital Medical University

Locations

Neurosurgical ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 26445777 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24760352 (View on PubMed)

Other Identifiers

KY-2013-002-003

Identifier Type: -

Identifier Source: org_study_id