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 osmolalityConcentration 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
|