Anomaly; Venous ReturnNCT01748513
Volume-challenge in Morbid Obesity
An observational study of Anomaly; Venous Return, run by Umeå University at 1 site in Sweden.
Trial summary
Preoperative venous return stability and euvolemia is essential in management of morbidly obese patients. Fluid therapy regimes for patients with high BMI, especially with focus on preoperative management, are rare and not in consensus.The aim of this study was to evaluate preoperative effects of a standardized, ideal… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anomaly; Venous Return
- What is being tested?
- preoperative venous return optimizing
- How many people
- 34 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2011to Apr 2013
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Morbidly obese patients scheduled for bariatric surgery in Northern part of Sweden; Norrbotten county council.
Who may be able to join
- enrolled for bariatric surgery
- BMI ≥ 40 or ≥ 35kg/m2 with co-morbidities
- preoperative three-weeks preparation by rapid-weight-loss-diet and weight loss
Who cannot join
- untreated significant hypertension
- unstable angina pectoris
- significant valve regurgitation or stenosis
- known severe pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Morbid Obesity and Optimization of Preoperative Fluid Therapy
Preoperative venous return stability and euvolemia is essential in management of morbidly obese patients. Fluid therapy regimes for patients with high BMI, especially with focus on preoperative management, are rare and not in consensus.The aim of this study was to evaluate preoperative effects of a standardized, ideal body weight (IBW) based volume-challenge on hemodynamics, stroke volume and level of venous return to the heart.
Read the detailed description
34 morbidly obese patients scheduled for bariatric surgery underwent a preoperative three-week preparation by rapid-weight-loss-diet (RWL) to be accepted for bariatric surgery. Preoperative transthoracic echocardiography (TTE) was performed in the awake state before and after volume-challenge (VC) based on 6ml colloids /kg IBW. Feasibility of standardized VC was evaluated by TTE. Dynamic and non-dynamic echocardiographic indices for VC were studied.
Main outcome measures: Volume-responsiveness and level of venous return before and after volume-challenge were assessed by TTE. An increase of stroke volume ≥ 13% was considered as a volume-responder.
- Conditions
- Anomaly; Venous Return
- Being tested
- preoperative venous return optimizing
- Keywords
- morbidly obese patients,, preoperative volume-challenge,, transthoracic echocardiography,, TTE,, rapid weight loss,, venous return,, bariatric surgery,, left ventricular outflow tract,, stroke volume,, diastolic function,, hypervolemia,, hypovolemia
- Medical subject headings
- Congenital Abnormalities, Edema, Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative venous return optimizingOther
Preoperative transthoracic echocardiography (TTE) was performed in the awake state before and after volume challenge based on 6ml colloids /kg ideal body weight.
| Study group | Role | What they receive |
|---|---|---|
| preoperative venous return optimizing | Morbidly obese patients scheduled for bariatric surgery Receives: Other: preoperative venous return optimizing |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of venous return
Measured: 0,1 hour
Secondary outcomes (1)
Volume-responsiveness
Measured: 0,1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startMar 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anomaly; Venous ReturnStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomi Pösö, Umeå University
- Investigators
- Tomi P Pösö, MD, Principal investigator, Norrbotten county council, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748513
- Sponsor's protocol ID
- 09-042M
- Status last verified
- Apr 2013
- First submitted
- 10 Dec 2012
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbid Obesity and Optimization of Preoperative Fluid Therapy
- ClinicalTrials.gov ID
- NCT01748513
- Acronym / sponsor ID
- 09-042M
- Conditions
- Anomaly; Venous Return
- Keywords
- morbidly obese patients,, preoperative volume-challenge,, transthoracic echocardiography,, TTE,, rapid weight loss,, venous return,, bariatric surgery,, left ventricular outflow tract,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 12 Dec 2012 (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.
Preoperative venous return stability and euvolemia is essential in management of morbidly obese patients. Fluid therapy regimes for patients with high BMI, especially with focus on preoperative management, are rare and not in consensus.The aim of this study was to evaluate preoperative effects of a standardized, ideal body weight (IBW) based volume-challenge on hemodynamics, stroke volume and level of venous return to the heart.
Detailed description
34 morbidly obese patients scheduled for bariatric surgery underwent a preoperative three-week preparation by rapid-weight-loss-diet (RWL) to be accepted for bariatric surgery. Preoperative transthoracic echocardiography (TTE) was performed in the awake state before and after volume-challenge (VC) based on 6ml colloids /kg IBW. Feasibility of standardized VC was evaluated by TTE. Dynamic and non-dynamic echocardiographic indices for VC were studied.
Main outcome measures: Volume-responsiveness and level of venous return before and after volume-challenge were assessed by TTE. An increase of stroke volume ≥ 13% was considered as a volume-responder.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preoperative venous return optimizing | – | Other: preoperative venous return optimizingMorbidly obese patients scheduled for bariatric surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Morbidly obese patients scheduled for bariatric surgery in Northern part of Sweden; Norrbotten county council.
Key inclusion criteria (3 listed)
- enrolled for bariatric surgery
- BMI ≥ 40 or ≥ 35kg/m2 with co-morbidities
- preoperative three-weeks preparation by rapid-weight-loss-diet and weight loss
Key exclusion criteria (4 listed)
- untreated significant hypertension
- unstable angina pectoris
- significant valve regurgitation or stenosis
- known severe pulmonary disease
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 |
|---|---|---|
| preoperative venous return optimizingPreoperative transthoracic echocardiography (TTE) was performed in the awake state before and after volume challenge based on 6ml colloids /kg ideal body weight. | Other | preoperative venous return optimizing |
Primary outcome
level of venous return
Time frame: 0,1 hour
1 secondary outcome
Volume-responsiveness
Time frame: 0,1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
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.
Tomi P Pösö, MD principal investigator
Norrbotten county council, Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anomaly; Venous Return, run by Umeå University at 1 site 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of venous return (time frame: 0,1 hour). 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 30 Apr 2013.