NCT01748513

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 30, 2013

Status Verified

April 1, 2013

Enrollment Period

2.1 years

First QC Date

December 10, 2012

Last Update Submit

April 28, 2013

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

Outcome Measures

Primary Outcomes (1)

  • level of venous return

    0,1 hour

Secondary Outcomes (1)

  • Volume-responsiveness

    0,1 hour

Other Outcomes (1)

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

    1 hour

Study Arms (1)

preoperative venous return optimizing

Morbidly obese patients scheduled for bariatric surgery

Other: preoperative venous return optimizing

Interventions

preoperative venous return optimizingOTHER

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

preoperative venous return optimizing

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • enrolled for bariatric surgery
  • BMI ≥ 40 or ≥ 35kg/m2 with co-morbidities
  • preoperative three-weeks preparation by rapid-weight-loss-diet and weight loss

You may not qualify if:

  • untreated significant hypertension
  • unstable angina pectoris
  • significant valve regurgitation or stenosis
  • known severe pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunderby county hospital

Luleå, Norrbotten County, 97180, Sweden

Location

MeSH Terms

Conditions

Congenital AbnormalitiesEdemaHypovolemia

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Tomi P Pösö, MD

    Norrbotten county council, Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 10, 2012

First Posted

December 12, 2012

Study Start

March 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 30, 2013

Record last verified: 2013-04

Locations

SE(1)