Volume-challenge in Morbid Obesity | NCT01748513

Studies
Volume-challenge in Morbid Obesity

NCT01748513

Sponsor

Umeå University

Status

Completed

Last Update Posted

Apr 30, 2013Estimated

Enrollment

34Actual

Phase

Not provided

Conditions

Anomaly; Venous Return

Interventions

preoperative venous return optimizing

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Dec 10, 2012

First Submission Date that Met QC Criteria

Dec 10, 2012

First Posted Date

Dec 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2013

Last Update Posted Date

Apr 30, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

Anomaly; Venous Return

Keywords

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
preoperative venous return optimizing		Morbidly obese patients scheduled for bariatric surgery	Other: preoperative venous return optimizing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
level of venous return		0,1 hour

Secondary Outcomes

Measure	Description	Time Frame
Volume-responsiveness		0,1 hour

Other Outcomes

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tomi P Pösö, MD	Norrbotten county council, Umeå University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sunderby county hospital		Luleå	Norrbotten County	97180	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D000013	Congenital Abnormalities
D004487	Edema
D020896	Hypovolemia

Ancestor Terms

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010335	Pathologic Processes

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Browse Branches

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