Postoperative Hyponatremia - Are There Gender Differences?
1 other identifier
interventional
60
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2008
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 10, 2008
CompletedFirst Posted
Study publicly available on registry
March 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJune 12, 2013
June 1, 2013
5.8 years
March 10, 2008
June 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change between preoperative and postoperative plasma sodium concentration
24 hrs
Study Arms (2)
I
EXPERIMENTALPerioperative fluid management based on body weight
II
ACTIVE COMPARATORPerioperative fluid management based on Lean Body Mass (LBM)
Interventions
Preoperative: bolus of 10 ml/kg body weight. During operation: 5 ml/kg body weight/hr. Postoperative: 3 ml/kg body weight/hr
Preoperative: bolus of 12 ml/kg LBM. During operation: 6 ml/kg LBM/hr. Postoperative: 3.5 ml/kg LBM/hr
Eligibility Criteria
You may qualify if:
- ASA Physical status I-II
- Subjects scheduled for otorinolaryngoiatric surgery in general anesthesia of at least 3 hours duration
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Department of Anesthesia and Intensive Care, Karolinska University Hospital Huddinge
Stockholm, Stockholm County, 14186, Sweden
Dept of Anaesthesia and Intensive Care, Kalmar County Hospital
Kalmar, 39185, Sweden
Department of Anaesthesia and Operation
Linköping, 58185, Sweden
Dept. of Anesthesiology and Intensive Care, Karolinska University Hospital, Solna
Stockholm, 171 76, Sweden
Dept of Anaesthesia and Intensive Care, Uppsala University Hospital
Uppsala, 75185, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Johan Ullman, MD., PhD.
Dept of Anesthesia and Intensive Care, Karolinska University Hospital, Stockholm,
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Consultant
Study Record Dates
First Submitted
March 10, 2008
First Posted
March 17, 2008
Study Start
March 1, 2008
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
June 12, 2013
Record last verified: 2013-06