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Postoperative Hyponatremia - Are There Gender Differences?

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ClinicalTrials.gov Identifier: NCT00636857
Recruitment Status : Unknown
Verified June 2013 by Vibeke Moen, Karolinska Institutet.
Recruitment status was:  Recruiting
First Posted : March 17, 2008
Last Update Posted : June 12, 2013
Sponsor:
Information provided by (Responsible Party):
Vibeke Moen, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE March 10, 2008
First Posted Date  ICMJE March 17, 2008
Last Update Posted Date June 12, 2013
Study Start Date  ICMJE March 2008
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2008)
Change between preoperative and postoperative plasma sodium concentration [ Time Frame: 24 hrs ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00636857 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postoperative Hyponatremia - Are There Gender Differences?
Official Title  ICMJE Postoperative Hyponatremia - Are There Gender Differences?
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Hyponatremia
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: I
    Perioperative fluid management based on body weight
    Intervention: Procedure: Fluid administration
  • Active Comparator: II
    Perioperative fluid management based on Lean Body Mass (LBM)
    Intervention: Procedure: Perioperative fluid management based on Lean Body Mass
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 10, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00636857
Other Study ID Numbers  ICMJE NKOISR10003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vibeke Moen, Karolinska Institutet
Study Sponsor  ICMJE Karolinska University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Johan Ullman, MD., PhD. Dept of Anesthesia and Intensive Care, Karolinska University Hospital, Stockholm,
PRS Account Karolinska University Hospital
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP