Volume-challenge in Morbid Obesity

Anomaly; Venous Return Clinical Trial

Official title:

Morbid Obesity and Optimization of Preoperative Fluid Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748513
• Other study ID #: 09-042M
• Status: Completed
• Phase: N/A
• First received: December 10, 2012
• Last updated: April 28, 2013
• Start date: March 2011
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anomaly; Venous Return
• Obesity, Morbid

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.

Locations

Country	Name	City	State
Sweden	Sunderby county hospital	Lulea	Norrbotten

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of feasibility of dynamic and non-dynamic echocardiographic indices for volume challenge		1 hour	No
Primary	level of venous return		0,1 hour	No
Secondary	Volume-responsiveness		0,1 hour	No