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Completed

NCT Number: NCT01748513

Volume-challenge in Morbid Obesity

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.

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Key information

Conditions

Anomaly; Venous Return Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Edema Hypovolemia Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sunderby county hospital

Luleå, Norrbotten County, 97180, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

preoperative venous return optimizing

Other

Preoperative transthoracic echocardiography (TTE) was performed in the awake state before and after volume challenge based on 6ml colloids /kg ideal body weight.

Primary outcomes

  1. level of venous return

    Time frame: 0,1 hour

Secondary outcomes

  1. Volume-responsiveness

    Time frame: 0,1 hour

Other outcomes

  1. Evaluation of feasibility of dynamic and non-dynamic echocardiographic indices for volume challenge

    Time frame: 1 hour

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

Morbid Obesity and Optimization of Preoperative Fluid Therapy

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 12, 2012
Registry last updated
Apr 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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