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

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ClinicalTrials.gov Identifier: NCT02037815
Recruitment Status : Completed
First Posted : January 16, 2014
Last Update Posted : July 30, 2014
Sponsor:
Information provided by (Responsible Party):
Jian-Xin Zhou, Capital Medical University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : January 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Difference between the measured and calculated serum osmolality. [ Time Frame: 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 :
  1. Serum osmolality [ Time Frame: 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 ]
  2. Concentration of serum sodium [ Time Frame: 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037815


Locations
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China, Beijing
Neurosurgical ICU, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Capital Medical University
Investigators
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Principal Investigator: Jian-Xin Zhou, MD Neurosurgical ICU, Beijing Tiantan Hospital, Capital Medical University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jian-Xin Zhou, Professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT02037815    
Other Study ID Numbers: KY-2013-002-003
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: July 2014
Keywords provided by Jian-Xin Zhou, Capital Medical University:
hyperosmolar drugs
mannitol
hypertonic saline
serum osmolality
correlation
Additional relevant MeSH terms:
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Brain Edema
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mannitol
 Pharmaceutical Solutions
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs