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NCT Number: NCT02037815

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Neurosurgical ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 16, 2014
Registry last updated
Jul 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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