Volume-challenge in Morbid Obesity

April 28, 2013 updated by: Tomi Pösö, Umeå University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Norrbotten
      • Lulea, Norrbotten, Sweden, 97180
        • Sunderby County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
level of venous return
Time Frame: 0,1 hour
0,1 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
Volume-responsiveness
Time Frame: 0,1 hour
0,1 hour

Other Outcome Measures

Outcome Measure
Time Frame
Evaluation of feasibility of dynamic and non-dynamic echocardiographic indices for volume challenge
Time Frame: 1 hour
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Investigators

  • Principal Investigator: Tomi P Pösö, MD, Norrbotten county council, Umeå University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

December 10, 2012

First Submitted That Met QC Criteria

December 10, 2012

First Posted (Estimate)

December 12, 2012

Study Record Updates

Last Update Posted (Estimate)

April 30, 2013

Last Update Submitted That Met QC Criteria

April 28, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-042M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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