ObesityNCT01052519
Obesity and Goal-directed Intraoperative Fluid Therapy
A study testing Goal directed fluid therapy in people with Obesity, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of the study is to compare non-obese patients (BMI≤ 30 kg/m2)versus obese patients (BMI> 30 kg/m2) in regard of their respective needs for intraoperative fluid therapy during laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Goal directed fluid therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2010to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-obese (BMI≤ 30kg/m2) and obese patients (BMI > 30 kg/m2)
- undergoing laparoscopic elective fundoplication or elective bariatric surgery
Who cannot join
- decompensate heart failure
- documented coronary artery disease
- renal insufficiency
- severe chronic obstructive pulmonary disease
- symptoms of infection or sepsis
- esophageal disease (excepting gastro-esophageal reflux without any other esophageal alteration).
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Anesthesiology, Medical University of Vienna
Vienna, A-1070
About this study
Official title: Intraoperative Goal-directed Fluid Management in Non-Obese and Obese Patients Undergoing Laparoscopic Surgery
The purpose of the study is to compare non-obese patients (BMI≤ 30 kg/m2)versus obese patients (BMI> 30 kg/m2) in regard of their respective needs for intraoperative fluid therapy during laparoscopic surgery.
Specifically the investigators will test the hypothesis that subcutaneous tissue oxygenation (PsqO2)is increased in obese patients when fluid management is optimized by means of esophageal Doppler monitoring compared to obese patients undergoing standard fluid management.
Furthermore the investigators will test the hypothesis that PsqO2 is decreased in obese patients undergoing conventional fluid therapy compared to non-obese patients when fluid management is optimized. Thus the investigators assume that PsqO2 is similar in obese and non-obese patients when fluid management is optimized in both groups.
Read the detailed description
Hemodynamic stability and normovolemia are critical determinants of tissue perfusion and oxygenation. Adequate tissue oxygenation is essential to maintain normal physiologic functions and to reduce complications, such as wound infections.
Fat tissue is relatively hypoperfused and, therefore, poorly oxygenated. Subcutaneous tissue oxygenation in the obese is thus critically low and even supplemental oxygen only slightly increases subcutaneous oxygenation.It is likely that poor subcutaneous oxygenation in the obese surgical patients results in part from inadequate intraoperative fluid replacement.
It remains unknown how to hydrate obese surgical patients best. The most physiologic approach for perioperative fluid replacement is now thought to be goal-directed management, using stroke volume as the treatment parameter.
- Conditions
- Obesity
- Being tested
- Goal directed fluid therapy
- Keywords
- Obesity, Esophageal Doppler monitoring, tissue oxygen tension
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal directed fluid therapyOther
Fluid will be administered to reach maximal stroke volume during the intraoperative period.
| Study group | Role | What they receive |
|---|---|---|
| obese control | No intervention | Not described |
| obese goal-directed | Active comparator | Not described Receives: Other: Goal directed fluid therapy |
| non-obese goal directed | Active comparator | Not described Receives: Other: Goal directed fluid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subcutaneous tissue oxygenation
Measured: intraoperative and 2 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Kabon, Medical University of Vienna
- Investigators
- Barbara Kabon, MD, Principal investigator, MUW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052519
- Sponsor's protocol ID
- 708/2009, local IRB
- Status last verified
- Nov 2014
- First submitted
- 19 Jan 2010
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kabon B, Nagele A, Reddy D, Eagon C, Fleshman JW, Sessler DI, Kurz A. Obesity decreases perioperative tissue oxygenation. Anesthesiology. 2004 Feb;100(2):274-80. doi: 10.1097/00000542-200402000-00015.
PubMed 14739800Fleischmann E, Kurz A, Niedermayr M, Schebesta K, Kimberger O, Sessler DI, Kabon B, Prager G. Tissue oxygenation in obese and non-obese patients during laparoscopy. Obes Surg. 2005 Jun-Jul;15(6):813-9. doi: 10.1381/0960892054222867.
PubMed 15978153Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.
PubMed 12357146Muhlbacher J, Luf F, Zotti O, Herkner H, Fleischmann E, Kabon B. Effect of Intraoperative Goal-Directed Fluid Management on Tissue Oxygen Tension in Obese Patients: a Randomized Controlled Trial. Obes Surg. 2021 Mar;31(3):1129-1138. doi: 10.1007/s11695-020-05106-x. Epub 2020 Nov 27.
PubMed 33244655
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Goal-directed Fluid Management in Non-Obese and Obese Patients Undergoing Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01052519
- Acronym / sponsor ID
- 708/2009, local IRB
- Conditions
- Obesity
- Keywords
- Obesity, Esophageal Doppler monitoring, tissue oxygen tension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare non-obese patients (BMI≤ 30 kg/m2)versus obese patients (BMI> 30 kg/m2) in regard of their respective needs for intraoperative fluid therapy during laparoscopic surgery.
Specifically the investigators will test the hypothesis that subcutaneous tissue oxygenation (PsqO2)is increased in obese patients when fluid management is optimized by means of esophageal Doppler monitoring compared to obese patients undergoing standard fluid management.
Furthermore the investigators will test the hypothesis that PsqO2 is decreased in obese patients undergoing conventional fluid therapy compared to non-obese patients when fluid management is optimized. Thus the investigators assume that PsqO2 is similar in obese and non-obese patients when fluid management is optimized in both groups.
Detailed description
Hemodynamic stability and normovolemia are critical determinants of tissue perfusion and oxygenation. Adequate tissue oxygenation is essential to maintain normal physiologic functions and to reduce complications, such as wound infections.
Fat tissue is relatively hypoperfused and, therefore, poorly oxygenated. Subcutaneous tissue oxygenation in the obese is thus critically low and even supplemental oxygen only slightly increases subcutaneous oxygenation.It is likely that poor subcutaneous oxygenation in the obese surgical patients results in part from inadequate intraoperative fluid replacement.
It remains unknown how to hydrate obese surgical patients best. The most physiologic approach for perioperative fluid replacement is now thought to be goal-directed management, using stroke volume as the treatment parameter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| obese control | No intervention | – |
| obese goal-directed | Active comparator | Other: Goal directed fluid therapy |
| non-obese goal directed | Active comparator | Other: Goal directed fluid therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-obese (BMI≤ 30kg/m2) and obese patients (BMI > 30 kg/m2)
- undergoing laparoscopic elective fundoplication or elective bariatric surgery
Key exclusion criteria (6 listed)
- decompensate heart failure
- documented coronary artery disease
- renal insufficiency
- severe chronic obstructive pulmonary disease
- symptoms of infection or sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal directed fluid therapyFluid will be administered to reach maximal stroke volume during the intraoperative period. | Other | non-obese goal directed, obese goal-directed |
Primary outcome
Subcutaneous tissue oxygenation
Time frame: intraoperative and 2 postoperative hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
- Background: PubMed 14739800Kabon B, Nagele A, Reddy D, Eagon C, Fleshman JW, Sessler DI, Kurz A. Obesity decreases perioperative tissue oxygenation. Anesthesiology. 2004 Feb;100(2):274-80. doi: 10.1097/00000542-200402000-00015.
- Background: PubMed 15978153Fleischmann E, Kurz A, Niedermayr M, Schebesta K, Kimberger O, Sessler DI, Kabon B, Prager G. Tissue oxygenation in obese and non-obese patients during laparoscopy. Obes Surg. 2005 Jun-Jul;15(6):813-9. doi: 10.1381/0960892054222867.
- Background: PubMed 12357146Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.
- Derived from this study: PubMed 33244655Muhlbacher J, Luf F, Zotti O, Herkner H, Fleischmann E, Kabon B. Effect of Intraoperative Goal-Directed Fluid Management on Tissue Oxygen Tension in Obese Patients: a Randomized Controlled Trial. Obes Surg. 2021 Mar;31(3):1129-1138. doi: 10.1007/s11695-020-05106-x. Epub 2020 Nov 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Kabon, MD principal investigator
MUW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal directed fluid therapy in people with Obesity, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subcutaneous tissue oxygenation (time frame: intraoperative and 2 postoperative hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01052519, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2014.