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Volume-challenge in Morbid Obesity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01748513
First Posted: December 12, 2012
Last Update Posted: April 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tomi Pösö, Umeå University
  Purpose
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.

Condition Intervention
Anomaly; Venous Return Other: preoperative venous return optimizing

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Morbid Obesity and Optimization of Preoperative Fluid Therapy

Further study details as provided by Tomi Pösö, Umeå University:

Primary Outcome Measures:
  • level of venous return [ Time Frame: 0,1 hour ]

Secondary Outcome Measures:
  • Volume-responsiveness [ Time Frame: 0,1 hour ]

Other Outcome Measures:
  • Evaluation of feasibility of dynamic and non-dynamic echocardiographic indices for volume challenge [ Time Frame: 1 hour ]

Enrollment: 34
Study Start Date: March 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
preoperative venous return optimizing
Morbidly obese patients scheduled for bariatric surgery
Other: preoperative venous return optimizing
Preoperative transthoracic echocardiography (TTE) was performed in the awake state before and after volume challenge based on 6ml colloids /kg ideal body weight.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Morbidly obese patients scheduled for bariatric surgery in Northern part of Sweden; Norrbotten county council.
Criteria

Inclusion Criteria:

  • enrolled for bariatric surgery
  • BMI ≥ 40 or ≥ 35kg/m2 with co-morbidities
  • preoperative three-weeks preparation by rapid-weight-loss-diet and weight loss

Exclusion Criteria:

  • untreated significant hypertension
  • unstable angina pectoris
  • significant valve regurgitation or stenosis
  • known severe pulmonary disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748513


Locations
Sweden
Sunderby county hospital
Lulea, Norrbotten, Sweden, 97180
Sponsors and Collaborators
Umeå University
Investigators
Principal Investigator: Tomi P Pösö, MD Norrbotten county council, Umeå University
  More Information

Responsible Party: Tomi Pösö, MD, Umeå University
ClinicalTrials.gov Identifier: NCT01748513     History of Changes
Other Study ID Numbers: 09-042M
First Submitted: December 10, 2012
First Posted: December 12, 2012
Last Update Posted: April 30, 2013
Last Verified: April 2013

Keywords provided by Tomi Pösö, Umeå University:
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

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms