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Hyponatremia | Postoperative Hyponatremia - Are There Gender Differences?

Hyponatremia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hyponatremia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Procedure:Perioperative fluid management based on Lean Body MassPreoperative: bolus of 12 ml/kg LBM. During operation: 6 ml/kg LBM/hr. Postoperative: 3.5 ml/kg LBM/hr

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

IPerioperative fluid management based on body weight

IIPerioperative fluid management based on Lean Body Mass (LBM)

Study Status

Unknown status

Start Date: March 2008

Completed Date: December 2013

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Change between preoperative and postoperative plasma sodium concentration

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Johan Ullman, MD., PhD.

Lead Sponsor: Karolinska University Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00636857

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