Postoperative Hyponatremia - Are There Gender Differences?

Hyponatremia Clinical Trial

Official title:

Postoperative Hyponatremia - Are There Gender Differences?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00636857
• Other study ID #: NKOISR10003
• Status: Recruiting
• Phase: N/A
• First received: March 10, 2008
• Last updated: June 11, 2013
• Start date: March 2008
• Est. completion date: December 2013

Study information

• Verified date: June 2013
• Source: Karolinska University Hospital
• Contact: Johan Ullman, MD., PhD.
• Phone: +46 8 51 77 00 00
• Email: johan.ullman[@]karolinska.se
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyponatremia

Intervention

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
• 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

Locations

Country	Name	City	State
Sweden	Dept of Anaesthesia and Intensive Care, Kalmar County Hospital	Kalmar
Sweden	Department of Anaesthesia and Operation	Linkoping
Sweden	Department of Anesthesia and Intensive Care, Karolinska University Hospital Huddinge	Stockholm
Sweden	Dept. of Anesthesiology and Intensive Care, Karolinska University Hospital, Solna	Stockholm
Sweden	Dept of Anaesthesia and Intensive Care, Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change between preoperative and postoperative plasma sodium concentration		24 hrs	No