Volume-challenge in Morbid Obesity

Completed

• Conditions: Anomaly; Venous Return
• Interventions: Other: preoperative venous return optimizing

• Registration Number: NCT01748513
• Lead Sponsor: Umeå University

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 Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-12
• Status Verified: 2013-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-28
• Last Update Posted: 2013-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
preoperative venous return optimizing	preoperative venous return optimizing	Morbidly obese patients scheduled for bariatric surgery

Primary Outcome Measures

Name	Time	Method
level of venous return	0,1 hour

Secondary Outcome Measures

Name	Time	Method
Volume-responsiveness	0,1 hour

Trial Locations

Locations (1)

Sunderby county hospital; 🇸🇪 Lulea, Norrbotten, Sweden