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

Information source: Capital Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain Edema

Intervention: 20% mannitol solution, 125 ml, IV infusion in 15 min (Drug); 3.1% sodium chloride solution, 125 ml, IV infusion in 15 min (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Capital Medical University

Official(s) and/or principal investigator(s):
Jian-Xin Zhou, MD, Principal Investigator, Affiliation: Neurosurgical ICU, Beijing Tiantan Hospital, Capital Medical University

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.

Clinical Details

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

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

Primary outcome: Difference between the measured and calculated serum osmolality.

Secondary outcome:

Serum osmolality

Concentration of serum sodium

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Neurosurgical ICU, Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing 100050, China
Additional Information

Starting date: January 2014
Last updated: July 29, 2014

Page last updated: August 23, 2015

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