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
  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

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • level of venous return [ Time Frame: 0,1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Volume-responsiveness [ Time Frame: 0,1 hour ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Evaluation of feasibility of dynamic and non-dynamic echocardiographic indices for volume challenge [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Tomi Pösö, MD, Umeå University
ClinicalTrials.gov Identifier: NCT01748513     History of Changes
Other Study ID Numbers: 09-042M
Study First Received: December 10, 2012
Last Updated: April 28, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by 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
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014