Postoperative Hyponatremia - Are There Gender Differences?

NCT ID: NCT00636857

Last Updated: 2013-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Hyponatremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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I

Perioperative fluid management based on body weight

Group Type EXPERIMENTAL

Fluid administration

Intervention Type PROCEDURE

Preoperative: bolus of 10 ml/kg body weight. During operation: 5 ml/kg body weight/hr. Postoperative: 3 ml/kg body weight/hr

II

Perioperative fluid management based on Lean Body Mass (LBM)

Group Type ACTIVE_COMPARATOR

Perioperative fluid management based on Lean Body Mass

Intervention Type PROCEDURE

Preoperative: bolus of 12 ml/kg LBM. During operation: 6 ml/kg LBM/hr. Postoperative: 3.5 ml/kg LBM/hr

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

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Fluid administration by body weight Fluid administration by Lean Body Mass

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Vibeke Moen

Senior Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johan Ullman, MD., PhD.

Role: PRINCIPAL_INVESTIGATOR

Dept of Anesthesia and Intensive Care, Karolinska University Hospital, Stockholm,

Locations

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Department of Anesthesia and Intensive Care, Karolinska University Hospital Huddinge

Stockholm, Stockholm County, Sweden

Site Status RECRUITING

Dept of Anaesthesia and Intensive Care, Kalmar County Hospital

Kalmar, , Sweden

Site Status NOT_YET_RECRUITING

Department of Anaesthesia and Operation

Linköping, , Sweden

Site Status RECRUITING

Dept. of Anesthesiology and Intensive Care, Karolinska University Hospital, Solna

Stockholm, , Sweden

Site Status RECRUITING

Dept of Anaesthesia and Intensive Care, Uppsala University Hospital

Uppsala, , Sweden

Site Status TERMINATED

Countries

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Sweden

Central Contacts

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Johan Ullman, MD., PhD.

Role: CONTACT

+46 8 51 77 00 00

Vibeke Moen, MD

Role: CONTACT

+4648081200

Facility Contacts

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Anna Januszkiewics, M.D. Ph.D

Role: primary

+ 46 8 58580998

Vibeke Moen, MD

Role: primary

+46 480 81200

Christina Eintrei, PhD

Role: primary

Other Identifiers

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NKOISR10003

Identifier Type: -

Identifier Source: org_study_id

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