Postoperative Hyponatremia - Are There Gender Differences?

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.

Study Overview

• Status: Unknown
• Conditions: Hyponatremia
• Intervention / Treatment: Procedure: Fluid administration; Procedure: Perioperative fluid management based on 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johan Ullman, MD., PhD.; Phone Number: +46 8 51 77 00 00; Email: johan.ullman@karolinska.se
• Study Contact Backup: Name: Vibeke Moen, MD; Phone Number: +4648081200; Email: vibekem@ltkalmar.se

Study Locations

• Sweden
  • Kalmar, Sweden, 39185
    • Not yet recruiting
    • Dept of Anaesthesia and Intensive Care, Kalmar County Hospital
    • Contact: Vibeke Moen, MD; Phone Number: +46 480 81200; Email: vibekem@ltkalmar.se
    • Principal Investigator: Vibeke Moen, MD
  • Linkoping, Sweden, 58185
    • Recruiting
    • Department of Anaesthesia and Operation
    • Contact: Christina Eintrei, PhD; Email: christina.eintrei@liu.se
    • Sub-Investigator: Patrik Johansson, MD
    • Principal Investigator: Christina Eintrei, PhD
  • Stockholm, Sweden, 14186
    • Recruiting
    • Department of Anesthesia and Intensive Care, Karolinska University Hospital Huddinge
    • Contact: Anna Januszkiewics, M.D. Ph.D; Phone Number: + 46 8 58580998; Email: anna.januszkiewics@karolinska.se
    • Principal Investigator: Selma Najeeb, MD
  • Stockholm, Sweden, 171 76
    • Recruiting
    • Dept. of Anesthesiology and Intensive Care, Karolinska University Hospital, Solna
    • Principal Investigator: Johan Ullman, MD, PhD
  • Uppsala, Sweden, 75185
    • Terminated
    • Dept of Anaesthesia and Intensive Care, Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Fluid administration by Lean Body Mass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change between preoperative and postoperative plasma sodium concentration	24 hrs

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Investigators: Principal Investigator: Johan Ullman, MD., PhD., Dept of Anesthesia and Intensive Care, Karolinska University Hospital, Stockholm,

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: March 10, 2008
• First Submitted That Met QC Criteria: March 10, 2008
• First Posted (Estimate): March 17, 2008

Study Record Updates

• Last Update Posted (Estimate): June 12, 2013
• Last Update Submitted That Met QC Criteria: June 11, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Water-Electrolyte Imbalance
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyponatremia
• Other Study ID Numbers: NKOISR10003