MedDataX Logo

Volume-challenge in Morbid Obesity

NCT ID: NCT01748513

Last Updated: 2013-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Anomaly; Venous Return

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

preoperative venous return optimizing

Morbidly obese patients scheduled for bariatric surgery

preoperative venous return optimizing

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Umeå University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tomi Pösö

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tomi P Pösö, MD

Role: PRINCIPAL_INVESTIGATOR

Norrbotten county council, Umeå University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sunderby county hospital

Luleå, Norrbotten County, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

09-042M

Identifier Type: -

Identifier Source: org_study_id