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Postoperative Hyponatremia - Are There Gender Differences?

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by Karolinska University Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Vibeke Moen, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00636857
First received: March 10, 2008
Last updated: June 11, 2013
Last verified: June 2013
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Postoperative Hyponatremia - Are There Gender Differences?

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Change between preoperative and postoperative plasma sodium concentration [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Perioperative fluid management based on body weight
Procedure: Fluid administration
Preoperative: bolus of 10 ml/kg body weight. During operation: 5 ml/kg body weight/hr. Postoperative: 3 ml/kg body weight/hr
Other Name: Fluid administration by body weight
Active Comparator: II
Perioperative fluid management based on Lean Body Mass (LBM)
Procedure: Perioperative fluid management based on Lean Body Mass
Preoperative: bolus of 12 ml/kg LBM. During operation: 6 ml/kg LBM/hr. Postoperative: 3.5 ml/kg LBM/hr
Other Name: Fluid administration by Lean Body Mass

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636857

Locations
Sweden
Dept of Anaesthesia and Intensive Care, Kalmar County Hospital
Kalmar, Sweden, 39185
Department of Anaesthesia and Operation
Linkoping, Sweden, 58185
Department of Anesthesia and Intensive Care, Karolinska University Hospital Huddinge
Stockholm, Sweden, 14186
Dept. of Anesthesiology and Intensive Care, Karolinska University Hospital, Solna
Stockholm, Sweden, 171 76
Dept of Anaesthesia and Intensive Care, Uppsala University Hospital
Uppsala, Sweden, 75185
Sponsors and Collaborators
Karolinska University Hospital
Investigators
Principal Investigator: Johan Ullman, MD., PhD. Dept of Anesthesia and Intensive Care, Karolinska University Hospital, Stockholm,
  More Information

Responsible Party: Vibeke Moen, Senior Consultant, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00636857     History of Changes
Other Study ID Numbers: NKOISR10003 
Study First Received: March 10, 2008
Last Updated: June 11, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Karolinska University Hospital:
Water-Electrolyte Imbalance

Additional relevant MeSH terms:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on December 06, 2016