HyponatremiaNCT00636857
Postoperative Hyponatremia - Are There Gender Differences?
A study testing Fluid administration and Perioperative fluid management based on Lean Body Mass in people with Hyponatremia, run by Karolinska University Hospital at 5 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hyponatremia
- What is being tested?
- Fluid administration and Perioperative fluid management based on Lean Body Mass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesSweden
- Study dates
- Mar 2008to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA Physical status I-II
- Subjects scheduled for otorinolaryngoiatric surgery in general anesthesia of at least 3 hours duration
Who cannot join
- BMI less than 18
- BMI greater than 33
- Diabetes mellitus requiring medication
- Treatment with diuretics
- ACE-inhibitors
- Angiotensin II antagonists
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- Cortisone
- Lithium
- Diseases of the kidney
- Females:
- Pregnancy
- Menopause
- Endocrine dysfunction influencing menstruation
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites, 4 recruiting
- Not yet recruiting
Dept of Anaesthesia and Intensive Care, Kalmar County Hospital
Kalmar, 39185
Vibeke Moen, MD, +46 480 81200, vibekem@ltkalmar.se
Vibeke Moen, MD
- Recruiting
Department of Anaesthesia and Operation
Linköping, 58185
Christina Eintrei, PhD, christina.eintrei@liu.se
Patrik Johansson, MD
- Recruiting
Department of Anesthesia and Intensive Care, Karolinska University Hospital Huddinge
Stockholm, Stockholm County, 14186
Anna Januszkiewics, M.D. Ph.D, + 46 8 58580998, anna.januszkiewics@karolinska.se
Selma Najeeb, MD
- Recruiting
Dept. of Anesthesiology and Intensive Care, Karolinska University Hospital, Solna
Stockholm, 171 76
Johan Ullman, MD, PhD
- Terminated
Dept of Anaesthesia and Intensive Care, Uppsala University Hospital
Uppsala, 75185
About 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.
Read the 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.
- Conditions
- Hyponatremia
- Being tested
- Fluid administration, Perioperative fluid management based on Lean Body Mass
- Keywords
- Water-Electrolyte Imbalance
- Medical subject headings
- Hyponatremia, Water-Electrolyte Imbalance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid administrationProcedure or surgery
Also called Fluid administration by body weight
Preoperative: bolus of 10 ml/kg body weight. During operation: 5 ml/kg body weight/hr. Postoperative: 3 ml/kg body weight/hr
Perioperative fluid management based on Lean Body MassProcedure or surgery
Also called Fluid administration by Lean Body Mass
Preoperative: bolus of 12 ml/kg LBM. During operation: 6 ml/kg LBM/hr. Postoperative: 3.5 ml/kg LBM/hr
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Perioperative fluid management based on body weight Receives: Procedure: Fluid administration |
| II | Active comparator | Perioperative fluid management based on Lean Body Mass (LBM) Receives: Procedure: Perioperative fluid management based on Lean Body Mass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change between preoperative and postoperative plasma sodium concentration
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vibeke Moen, Karolinska Institutet
- Investigators
- Johan Ullman, MD., PhD., Principal investigator, Dept of Anesthesia and Intensive Care, Karolinska University Hospital, Stockholm,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636857
- Sponsor's protocol ID
- NKOISR10003
- Status last verified
- Jun 2013
- First submitted
- 10 Mar 2008
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Hyponatremia - Are There Gender Differences?
- ClinicalTrials.gov ID
- NCT00636857
- Acronym / sponsor ID
- NKOISR10003
- Conditions
- Hyponatremia
- Keywords
- Water-Electrolyte Imbalance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 17 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Procedure: Fluid administrationPerioperative fluid management based on body weight |
| II | Active comparator | Procedure: Perioperative fluid management based on Lean Body MassPerioperative fluid management based on Lean Body Mass (LBM) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA Physical status I-II
- Subjects scheduled for otorinolaryngoiatric surgery in general anesthesia of at least 3 hours duration
Key exclusion criteria (13 listed)
- BMI less than 18
- BMI greater than 33
- Diabetes mellitus requiring medication
- Treatment with diuretics
- ACE-inhibitors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid administrationAlso: Fluid administration by body weightPreoperative: bolus of 10 ml/kg body weight. During operation: 5 ml/kg body weight/hr. Postoperative: 3 ml/kg body weight/hr | Procedure or surgery | I |
| Perioperative fluid management based on Lean Body MassAlso: Fluid administration by Lean Body MassPreoperative: bolus of 12 ml/kg LBM. During operation: 6 ml/kg LBM/hr. Postoperative: 3.5 ml/kg LBM/hr | Procedure or surgery | II |
Primary outcome
Change between preoperative and postoperative plasma sodium concentration
Time frame: 24 hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Ullman, MD., PhD. principal investigator
Dept of Anesthesia and Intensive Care, Karolinska University Hospital, Stockholm,
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid administration and Perioperative fluid management based on Lean Body Mass in people with Hyponatremia, run by Karolinska University Hospital at 5 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johan Ullman, MD., PhD. (+46 8 51 77 00 00, johan.ullman@karolinska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change between preoperative and postoperative plasma sodium concentration (time frame: 24 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2013.