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Postoperative Hyponatremia - Are There Gender Differences?

Primary Purpose

Hyponatremia

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Fluid administration
Perioperative fluid management based on Lean Body Mass
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyponatremia focused on measuring Water-Electrolyte Imbalance

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Dept of Anaesthesia and Intensive Care, Kalmar County Hospital
  • Department of Anaesthesia and OperationRecruiting
  • Department of Anesthesia and Intensive Care, Karolinska University Hospital HuddingeRecruiting
  • Dept. of Anesthesiology and Intensive Care, Karolinska University Hospital, SolnaRecruiting
  • Dept of Anaesthesia and Intensive Care, Uppsala University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

I

II

Arm Description

Perioperative fluid management based on body weight

Perioperative fluid management based on Lean Body Mass (LBM)

Outcomes

Primary Outcome Measures

Change between preoperative and postoperative plasma sodium concentration

Secondary Outcome Measures

Full Information

First Posted
March 10, 2008
Last Updated
June 11, 2013
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00636857
Brief Title
Postoperative Hyponatremia - Are There Gender Differences?
Official Title
Postoperative Hyponatremia - Are There Gender Differences?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyponatremia
Keywords
Water-Electrolyte Imbalance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
Perioperative fluid management based on body weight
Arm Title
II
Arm Type
Active Comparator
Arm Description
Perioperative fluid management based on Lean Body Mass (LBM)
Intervention Type
Procedure
Intervention Name(s)
Fluid administration
Other Intervention Name(s)
Fluid administration by body weight
Intervention Description
Preoperative: bolus of 10 ml/kg body weight. During operation: 5 ml/kg body weight/hr. Postoperative: 3 ml/kg body weight/hr
Intervention Type
Procedure
Intervention Name(s)
Perioperative fluid management based on Lean Body Mass
Other Intervention Name(s)
Fluid administration by Lean Body Mass
Intervention Description
Preoperative: bolus of 12 ml/kg LBM. During operation: 6 ml/kg LBM/hr. Postoperative: 3.5 ml/kg LBM/hr
Primary Outcome Measure Information:
Title
Change between preoperative and postoperative plasma sodium concentration
Time Frame
24 hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johan Ullman, MD., PhD.
Phone
+46 8 51 77 00 00
Email
johan.ullman@karolinska.se
First Name & Middle Initial & Last Name or Official Title & Degree
Vibeke Moen, MD
Phone
+4648081200
Email
vibekem@ltkalmar.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Ullman, MD., PhD.
Organizational Affiliation
Dept of Anesthesia and Intensive Care, Karolinska University Hospital, Stockholm,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Anaesthesia and Intensive Care, Kalmar County Hospital
City
Kalmar
ZIP/Postal Code
39185
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vibeke Moen, MD
Phone
+46 480 81200
Email
vibekem@ltkalmar.se
First Name & Middle Initial & Last Name & Degree
Vibeke Moen, MD
Facility Name
Department of Anaesthesia and Operation
City
Linkoping
ZIP/Postal Code
58185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Eintrei, PhD
Email
christina.eintrei@liu.se
First Name & Middle Initial & Last Name & Degree
Patrik Johansson, MD
First Name & Middle Initial & Last Name & Degree
Christina Eintrei, PhD
Facility Name
Department of Anesthesia and Intensive Care, Karolinska University Hospital Huddinge
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Januszkiewics, M.D. Ph.D
Phone
+ 46 8 58580998
Email
anna.januszkiewics@karolinska.se
First Name & Middle Initial & Last Name & Degree
Selma Najeeb, MD
Facility Name
Dept. of Anesthesiology and Intensive Care, Karolinska University Hospital, Solna
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johan Ullman, MD, PhD
Facility Name
Dept of Anaesthesia and Intensive Care, Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Individual Site Status
Terminated

12. IPD Sharing Statement

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Postoperative Hyponatremia - Are There Gender Differences?

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