ObesityNCT00554944
Intraoperative Goal-directed Fluid Management
A study testing Esophageal probe in people with Obesity and Abdominal Surgery, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The investigators propose to determine esophageal Doppler goal-directed fluid requirements in lean, overweight, obese, and morbidly obese patients with the goal of developing a body mass index (BMI)-specific fluid replacement strategy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Obesity, Abdominal Surgery, Hysterectomy
- What is being tested?
- Esophageal probe
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Feb 2010
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women, aged > 18 years old
- Scheduled for elective, open abdominal or vaginal hysterectomies.
- Patients will be recruited in the following body mass index categories:
- 18.5-24.9 BMI [kg/m2]
- 25.0-29.9 BMI [kg/m2]
- 30.0-34.9 BMI [kg/m2]
Show all 9Show fewer
- 35.0-39.9 BMI [kg/m2]
- 40.0-44.9 BMI [kg/m2]
- > 45 BMI [kg/m2]
Who cannot join
- Hysterectomies due to gynecologic cancer diagnosis
- Signs and/or symptoms of decompensate heart failure
- End-stage renal disease
- History of susceptibility to malignant hyperthermia or porphyria
- Esophageal disease (excepting gastro-esophageal reflux without any other esophageal alteration)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Goal-directed Fluid Management in Lean and Obese Patients
The investigators propose to determine esophageal Doppler goal-directed fluid requirements in lean, overweight, obese, and morbidly obese patients with the goal of developing a body mass index (BMI)-specific fluid replacement strategy. Specifically, th investigators will test the hypothesis that perioperative fluid requirements on a per-kg basis varies as a function of BMI. Individuals scheduled for elective, open abdominal surgeries, vaginal hysterectomies or genital prolapse repair will be eligible to participate
Read the detailed description
Recent evidence suggests that goal-directed fluid management using stroke volume (blood ejected by the heart) is the most physiologic approach for fluid replacement. We propose to develop a body mass index (BMI)-specific fluid replacement formula based on stroke volume guidance.
Arterial pulse pressure variation (dPP) induced by mechanical ventilation is a proposed predictor of fluid responsiveness as well. We will therefore also investigate if stroke volume (measured by esophageal Doppler monitoring) and pulse pressure variation comparably predict fluid responsiveness by simultaneously measuring both parameters.
Adequate tissue oxygenation is essential to maintain normal physiologic functions. Fat tissue oxygenation is critically low in the obese surgical patient. It is likely that poor fat tissue oxygenation results in part from inadequate fluid replacement. We propose to determine if fat tissue oxygenation is comparable from lean to morbidly obese patients when fluid replacement is optimized.
Individuals scheduled for elective, open abdominal surgeries, vaginal hysterectomies or genital prolapse repair will be assigned to six groups according to BMI, from lean to morbidly obese categories. The primary aim will be to develop a statistical equation for predicting fluid requirements as a function of BMI. A maximum of 100 patients will be able to detect an R-squared of 10% or more with 90% power at the 0.05 significance level, and will enable adequate estimation of the relationship of interest.
- Conditions
- Obesity, Abdominal Surgery, Hysterectomy, Genital Prolapse
- Being tested
- Esophageal probe
- Keywords
- Fluid Management, surgery, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal probeProcedure or surgery
Near-infrared spectroscopy (NIRS) sensor, polarographic-type tissue oxygen sensor (Licox®, esophageal probe
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop a statistical equation based on the BMI (Body Mass Index) that predicts fluid requirements in individuals scheduled for elective, open abdominal surgeries, vaginal hysterectomies or genital prolapse repair .
Measured: July, 2009
Secondary outcomes (1)
To identify whether tissue oxygenation is similar in lean, overweight, obese and morbidly obese patients when perioperative fluid management is optimized.
Measured: July, 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startJun 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: not progressing as anticipated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel I Sessler, MD, Study director, The Cleveland ClinicLeif Saager, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554944
- Sponsor's protocol ID
- 07-409
- Status last verified
- Jan 2017
- First submitted
- 6 Nov 2007
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Goal-directed Fluid Management in Lean and Obese Patients
- ClinicalTrials.gov ID
- NCT00554944
- Acronym / sponsor ID
- 07-409
- Conditions
- Obesity, Abdominal Surgery, Hysterectomy, Genital Prolapse
- Keywords
- Fluid Management, surgery, Obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not progressing as anticipated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 7 Nov 2007 (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 investigators propose to determine esophageal Doppler goal-directed fluid requirements in lean, overweight, obese, and morbidly obese patients with the goal of developing a body mass index (BMI)-specific fluid replacement strategy. Specifically, th investigators will test the hypothesis that perioperative fluid requirements on a per-kg basis varies as a function of BMI. Individuals scheduled for elective, open abdominal surgeries, vaginal hysterectomies or genital prolapse repair will be eligible to participate
Detailed description
Recent evidence suggests that goal-directed fluid management using stroke volume (blood ejected by the heart) is the most physiologic approach for fluid replacement. We propose to develop a body mass index (BMI)-specific fluid replacement formula based on stroke volume guidance.
Arterial pulse pressure variation (dPP) induced by mechanical ventilation is a proposed predictor of fluid responsiveness as well. We will therefore also investigate if stroke volume (measured by esophageal Doppler monitoring) and pulse pressure variation comparably predict fluid responsiveness by simultaneously measuring both parameters.
Adequate tissue oxygenation is essential to maintain normal physiologic functions. Fat tissue oxygenation is critically low in the obese surgical patient. It is likely that poor fat tissue oxygenation results in part from inadequate fluid replacement. We propose to determine if fat tissue oxygenation is comparable from lean to morbidly obese patients when fluid replacement is optimized.
Individuals scheduled for elective, open abdominal surgeries, vaginal hysterectomies or genital prolapse repair will be assigned to six groups according to BMI, from lean to morbidly obese categories. The primary aim will be to develop a statistical equation for predicting fluid requirements as a function of BMI. A maximum of 100 patients will be able to detect an R-squared of 10% or more with 90% power at the 0.05 significance level, and will enable adequate estimation of the relationship of interest.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women, aged > 18 years old
- Scheduled for elective, open abdominal or vaginal hysterectomies.
- 18.5-24.9 BMI [kg/m2]
- 25.0-29.9 BMI [kg/m2]
- 30.0-34.9 BMI [kg/m2]
Key exclusion criteria (5 listed)
- Hysterectomies due to gynecologic cancer diagnosis
- Signs and/or symptoms of decompensate heart failure
- End-stage renal disease
- History of susceptibility to malignant hyperthermia or porphyria
- Esophageal disease (excepting gastro-esophageal reflux without any other esophageal alteration)
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 |
|---|---|---|
| Esophageal probeNear-infrared spectroscopy (NIRS) sensor, polarographic-type tissue oxygen sensor (Licox®, esophageal probe | Procedure or surgery | – |
Primary outcome
To develop a statistical equation based on the BMI (Body Mass Index) that predicts fluid requirements in individuals scheduled for elective, open abdominal surgeries, vaginal hysterectomies or genital prolapse repair .
Time frame: July, 2009
1 secondary outcome
To identify whether tissue oxygenation is similar in lean, overweight, obese and morbidly obese patients when perioperative fluid management is optimized.
Time frame: July, 2008
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
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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.
Daniel I Sessler, MD study director
The Cleveland Clinic
Leif Saager, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal probe in people with Obesity and Abdominal Surgery, run by The Cleveland Clinic at 1 site in United States.
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 9 inclusion and 5 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: withdrawn, as of the sponsor's last update on 23 Jan 2017. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
To develop a statistical equation based on the BMI (Body Mass Index) that predicts fluid requirements in individuals scheduled for elective, open abdominal surgeries, vaginal hysterectomies or genital prolapse repair . (time frame: July, 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2017.