Goal Directed Fluid TherapyPhase 4FLO1NCT00860704
Goal Directed Fluid Therapy
A Phase 4 study testing fluidotherapy with ringer-lactate in people with Goal Directed Fluid Therapy, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Intraoperative fluid demand will be monitored by Esophageal Doppler in lean and obese patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Goal Directed Fluid Therapy
- What is being tested?
- fluidotherapy with ringer-lactate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2007to Dec 2012
- Phase
- Phase 4
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients (18 - 80 years) undergoing elective gynecological open surgery (hysterectomy, ovarian cysts and tumors, myomectomy, endometriosis)
Who cannot join
- cardiac insufficiency (EF< 35%)
- renal insufficiency (creatinin clearance <30ml/min, dialysis)
- insulin dependant diabetes mellitus
- coagulopathy
- NYHA IV
- infection
Show all 9Show fewer
- sepsis
- history of suspect malignant hyperthermia
- porphyria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Goal Directed Fluid Therapy in Lean and Obese Patients
Intraoperative fluid demand will be monitored by Esophageal Doppler in lean and obese patients.
Read the detailed description
To our knowledge no data are available on the effect of goal-directed fluid therapy on hemodynamics in lean patients and obese patients, respectively. Consequently, we want to compare lean patients (BMI <25) vs. obese patients (BMI >25) in regard of their respective needs for intraoperative fluid therapy, and the impact of the goal-directed fluid regimen on tissue oxygenation.
- Conditions
- Goal Directed Fluid Therapy
- Being tested
- fluidotherapy with ringer-lactate
- Keywords
- goal directed fluid therapy, lean patients, obese patients, crystalloids, Esophageal Doppler, tissue oxygenation, Fluid management during surgery, Fluid management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluidotherapy with ringer-lactateDrug
a bolus of 250ml ringer-lactate is administered, if there is fluid demand monitored by the Esophageal Doppler
| Study group | Role | What they receive |
|---|---|---|
| Ringerlactate lean | Active comparator | fluidtherapy with crystalloids in lean patients Receives: Drug: fluidotherapy with ringer-lactate |
| Ringerlactate overweight | Active comparator | fluidtherapy with crystalloids in overweight patients Receives: Drug: fluidotherapy with ringer-lactate |
| Ringerlactate obese | Active comparator | fluidtherapy with crystalloids in obese patients Receives: Drug: fluidotherapy with ringer-lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
different hemodynamic fluid responses in the different groups
Measured: every 10 minutes during surgery
Secondary outcomes (1)
Subcutaneous oxygen tension (PsqO2)
Measured: every 10 minutes during surgery and 2 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startNov 2007
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Goal Directed Fluid TherapyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Holzer, Medical University of Vienna
- Investigators
- Andrea Holzer, MD, Principal investigator, Medical University Vienna, Department of Anesthesiology and General Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860704
- Sponsor's protocol ID
- EK 299/2006
- Acronym
- FLO1
- Status last verified
- Oct 2018
- First submitted
- 11 Mar 2009
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Gan 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 12357146
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Goal Directed Fluid Therapy in Lean and Obese Patients
- ClinicalTrials.gov ID
- NCT00860704
- Acronym / sponsor ID
- FLO1 / EK 299/2006
- Conditions
- Goal Directed Fluid Therapy
- Keywords
- goal directed fluid therapy, lean patients, obese patients, crystalloids, Esophageal Doppler, tissue oxygenation, Fluid management during surgery, Fluid management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Mar 2009 (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.
Intraoperative fluid demand will be monitored by Esophageal Doppler in lean and obese patients.
Detailed description
To our knowledge no data are available on the effect of goal-directed fluid therapy on hemodynamics in lean patients and obese patients, respectively. Consequently, we want to compare lean patients (BMI <25) vs. obese patients (BMI >25) in regard of their respective needs for intraoperative fluid therapy, and the impact of the goal-directed fluid regimen on tissue oxygenation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ringerlactate lean | Active comparator | Drug: fluidotherapy with ringer-lactatefluidtherapy with crystalloids in lean patients |
| Ringerlactate overweight | Active comparator | Drug: fluidotherapy with ringer-lactatefluidtherapy with crystalloids in overweight patients |
| Ringerlactate obese | Active comparator | Drug: fluidotherapy with ringer-lactatefluidtherapy with crystalloids in obese patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- female patients (18 - 80 years) undergoing elective gynecological open surgery (hysterectomy, ovarian cysts and tumors, myomectomy, endometriosis)
Key exclusion criteria (9 listed)
- cardiac insufficiency (EF< 35%)
- renal insufficiency (creatinin clearance <30ml/min, dialysis)
- insulin dependant diabetes mellitus
- coagulopathy
- NYHA IV
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 |
|---|---|---|
| fluidotherapy with ringer-lactatea bolus of 250ml ringer-lactate is administered, if there is fluid demand monitored by the Esophageal Doppler | Drug | Ringerlactate lean, Ringerlactate obese, Ringerlactate overweight |
Primary outcome
different hemodynamic fluid responses in the different groups
Time frame: every 10 minutes during surgery
1 secondary outcome
Subcutaneous oxygen tension (PsqO2)
Time frame: every 10 minutes during surgery and 2 hours postoperatively
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 18 Oct 2018.
- 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.
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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.
Andrea Holzer, MD principal investigator
Medical University Vienna, Department of Anesthesiology and General Intensive Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fluidotherapy with ringer-lactate in people with Goal Directed Fluid Therapy, 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 1 inclusion and 9 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 18 Oct 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
different hemodynamic fluid responses in the different groups (time frame: every 10 minutes during surgery). 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 NCT00860704, which also lists 1 linked publication.
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 18 Oct 2018.