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Postoperative Hyponatremia - Are There Gender Differences?

K

Karolinska University Hospital

Status

Unknown

Conditions

Hyponatremia

Treatments

Procedure: Perioperative fluid management based on Lean Body Mass
Procedure: Fluid administration

Study type

Interventional

Funder types

Other

Identifiers

NCT00636857
NKOISR10003

Details and patient eligibility

About

The proposed study will focus on anesthesia and anesthesia-induced hypotension as a possible cause for postoperative fluid retention and hyponatremia, and investigate gender differences in this response.

Full description

30 healthy women and 30 healthy men, who are scheduled for surgery of the middle ear or parotic gland are included in the study. Within each gender group, the subjects are randomized to receive perioperative intravenous fluid regimes either based on body weight or lean body mass (LBM). The surgery lasts for at least 3 hours, the intervention period (fluid administration according to protocol) will last 10-12 hours, the study period will be 20-24 hours. Blood samples for analysis of plasma sodium, potassium, glucose and osmolality are collected preoperatively and the following morning together with analysis of urine produced during the study period.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ASA Physical status I-II
  • Subjects scheduled for otorinolaryngoiatric surgery in general anesthesia of at least 3 hours duration

Exclusion criteria

  • BMI less than 18

  • BMI greater than 33

  • Diabetes mellitus requiring medication

  • Treatment with diuretics

  • ACE-inhibitors

  • Angiotensin II antagonists

  • Cortisone

  • Lithium

  • Diseases of the kidney

  • Females:

    • Pregnancy
    • Menopause
    • Endocrine dysfunction influencing menstruation

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

I
Experimental group
Description:
Perioperative fluid management based on body weight
Treatment:
Procedure: Fluid administration
II
Active Comparator group
Description:
Perioperative fluid management based on Lean Body Mass (LBM)
Treatment:
Procedure: Perioperative fluid management based on Lean Body Mass

Trial contacts and locations

5

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Central trial contact

Vibeke Moen, MD; Johan Ullman, MD., PhD.

Data sourced from clinicaltrials.gov

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