Volume-challenge in Morbid Obesity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tomi Pösö, Umeå University
ClinicalTrials.gov Identifier:
NCT01748513
First received: December 10, 2012
Last updated: April 28, 2013
Last verified: April 2013

December 10, 2012
April 28, 2013
March 2011
April 2013   (final data collection date for primary outcome measure)
level of venous return [ Time Frame: 0,1 hour ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01748513 on ClinicalTrials.gov Archive Site
Volume-responsiveness [ Time Frame: 0,1 hour ] [ Designated as safety issue: No ]
Same as current
Evaluation of feasibility of dynamic and non-dynamic echocardiographic indices for volume challenge [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Same as current
 
Volume-challenge in Morbid Obesity
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.

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.

Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Morbidly obese patients scheduled for bariatric surgery in Northern part of Sweden; Norrbotten county council.

Anomaly; Venous Return
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.
preoperative venous return optimizing
Morbidly obese patients scheduled for bariatric surgery
Intervention: Other: preoperative venous return optimizing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01748513
09-042M
No
Tomi Pösö, Umeå University
Umeå University
Not Provided
Principal Investigator: Tomi P Pösö, MD Norrbotten county council, Umeå University
Umeå University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP