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Volume-challenge in Morbid Obesity

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.
 
ClinicalTrials.gov Identifier: NCT01748513
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : April 30, 2013
Sponsor:
Information provided by (Responsible Party):
Tomi Pösö, Umeå University

Tracking Information
First Submitted Date December 10, 2012
First Posted Date December 12, 2012
Last Update Posted Date April 30, 2013
Study Start Date March 2011
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 10, 2012)
level of venous return [ Time Frame: 0,1 hour ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 10, 2012)
Volume-responsiveness [ Time Frame: 0,1 hour ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 10, 2012)
Evaluation of feasibility of dynamic and non-dynamic echocardiographic indices for volume challenge [ Time Frame: 1 hour ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Volume-challenge in Morbid Obesity
Official Title Morbid Obesity and Optimization of Preoperative Fluid Therapy
Brief 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 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 Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Morbidly obese patients scheduled for bariatric surgery in Northern part of Sweden; Norrbotten county council.
Condition Anomaly; Venous Return
Intervention 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.
Study Groups/Cohorts preoperative venous return optimizing
Morbidly obese patients scheduled for bariatric surgery
Intervention: Other: preoperative venous return optimizing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 10, 2012)
34
Original Estimated Enrollment Same as current
Actual Study Completion Date April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT01748513
Other Study ID Numbers 09-042M
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Tomi Pösö, Umeå University
Study Sponsor Umeå University
Collaborators Not Provided
Investigators
Principal Investigator: Tomi P Pösö, MD Norrbotten county council, Umeå University
PRS Account Umeå University
Verification Date April 2013