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| Sponsored by: |
Karolinska University Hospital |
|---|---|
| Information provided by: | Karolinska University Hospital |
| ClinicalTrials.gov Identifier: | NCT00636857 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Hyponatremia |
Procedure: Fluid administration Procedure: Perioperative fluid management based on Lean Body Mass |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Postoperative Hyponatremia - Are There Gender Differences? |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
I: Experimental
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
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II: Active Comparator
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Females:
Contacts and Locations| Contact: Johan Ullman, MD., PhD. | +46 8 51 77 00 00 | johan.ullman@karolinska.se |
| Sweden | |
| Dept. of Anesthesiology and Intensive Care, Karolinska University Hospital, Solna | Recruiting |
| Stockholm, Sweden, 171 76 | |
| Principal Investigator: Johan Ullman, MD., PhD. | |
| Dept of Anaesthesia and Intensive Care, Uppsala University Hospital | Not yet recruiting |
| Uppsala, Sweden, 75185 | |
| Contact: Peter Frykholm, MD,D.E.E.A.,PhD +46 18 6114824 Peter.Frykholm@surgsci.uu.se | |
| Principal Investigator: Peter Frykholm, MD, D.E.E.A., PhD | |
| Dept of Anaesthesia and Intensive Care, Kalmar County Hospital | Not yet recruiting |
| Kalmar, Sweden, 39185 | |
| Contact: Vibeke Moen, MD +46 480 81200 vibekem@ltkalmar.se | |
| Principal Investigator: Vibeke Moen, MD | |
| Principal Investigator: | Johan Ullman, MD., PhD. | Dept. of Anesthesiology and Intensive Care, Karolinska Institute, Stockholm |
More Information
| Responsible Party: | Dept. of Anesthesiology and Intensive Care, Karolinska University Hospital ( Claes Frostell, MD., PhD. ) |
| Study ID Numbers: | NKOISR10003 |
| Study First Received: | March 10, 2008 |
| Last Updated: | March 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00636857 History of Changes |
| Health Authority: | Sweden: The National Board of Health and Welfare |
|
Water-Electrolyte Imbalance |
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Metabolic Diseases Hyponatremia Water-Electrolyte Imbalance Metabolic Disorder |
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Metabolic Diseases Hyponatremia Water-Electrolyte Imbalance |
