Esophageal CancerNCT02864355
Does Perioperative Goal Directed Therapy Using Flotrac Improve Outcomes in Esophagectomy Patients
A study testing Goal Directed Therapy in people with Esophageal Cancer, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The objective of this prospective, randomized controlled study is to ascertain whether the perioperative use of the FloTrac device to guide fluid and vasopressor management during esophagectomy improves patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Goal Directed Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older
- Patients undergoing primary resection of esophageal cancer and resultant esophagectomy.
Who cannot join
- Patients < 55kg or > 140 kg, based on literature regarding accuracy of FloTrac.
- Patients with sustained preoperative dysrhythmias, based on literature regarding accuracy of FloTrac (atrial flutter and/or atrial fibrillation).
- Patients with diagnosed NYHA class III-IV failure or documented EF < 30%
- Patients who are unable/unwilling to consent for study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29461
About this study
The objective of this prospective, randomized controlled study is to ascertain whether the perioperative use of the FloTrac device to guide fluid and vasopressor management during esophagectomy improves patient outcomes. The primary outcome is cardiopulmonary complications; however, the secondary outcome of decreasing patient morbidity (acute renal injury, anastomotic leak, and overall length of both ICU (intensive care unit) and hospital stay.
- Conditions
- Esophageal Cancer
- Being tested
- Goal Directed Therapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal Directed TherapyDevice
Participants in this group will have a FloTrac monitor attached to their arterial line and the Goal Directed Therapy algorithm will be followed to manage blood pressures.
| Study group | Role | What they receive |
|---|---|---|
| Goal Directed Therapy | Active comparator | In this arm patient will have the FloTrac monitor and a Goal Directed Therapy algorithm will be used to manage blood pressures. Receives: Device: Goal Directed Therapy |
| Usual Care | No intervention | Standard of care will be used to manage blood pressures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Cardiopulmonary Complications
Any documented cardiopulmonary complications present upon chart review.
Measured: 7 days
Secondary outcomes (5)
Anastomotic Leak Diagnosed Via Radiograph
Measured: 7 days
Number of Participants With Renal Injury
Measured: 7 days
Death
Measured: 30 days
Length of Intensive Care Unit Stay
Measured: 30 days
Hospital Length of Stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2020
- Study completionMar 2020
Why it stopped: Minimally invasive surgical methods have ceased enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George Guldan, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864355
- Sponsor's protocol ID
- Pro00045623
- Status last verified
- Feb 2021
- First submitted
- 15 Jul 2016
- Last updated
- 2 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Perioperative Goal Directed Therapy Using Flotrac Improve Outcomes in Esophagectomy Patients
- ClinicalTrials.gov ID
- NCT02864355
- Acronym / sponsor ID
- Pro00045623
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Minimally invasive surgical methods have ceased enrollment
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Posted 2 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this prospective, randomized controlled study is to ascertain whether the perioperative use of the FloTrac device to guide fluid and vasopressor management during esophagectomy improves patient outcomes. The primary outcome is cardiopulmonary complications; however, the secondary outcome of decreasing patient morbidity (acute renal injury, anastomotic leak, and overall length of both ICU (intensive care unit) and hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal Directed Therapy | Active comparator | Device: Goal Directed TherapyIn this arm patient will have the FloTrac monitor and a Goal Directed Therapy algorithm will be used to manage blood pressures. |
| Usual Care | No intervention | –Standard of care will be used to manage blood pressures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years of age or older
- Patients undergoing primary resection of esophageal cancer and resultant esophagectomy.
Key exclusion criteria (4 listed)
- Patients < 55kg or > 140 kg, based on literature regarding accuracy of FloTrac.
- Patients with sustained preoperative dysrhythmias, based on literature regarding accuracy of FloTrac (atrial flutter and/or atrial fibrillation).
- Patients with diagnosed NYHA class III-IV failure or documented EF < 30%
- Patients who are unable/unwilling to consent for study procedures
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 TherapyParticipants in this group will have a FloTrac monitor attached to their arterial line and the Goal Directed Therapy algorithm will be followed to manage blood pressures. | Device | Goal Directed Therapy |
Primary outcome
Number of Participants With Cardiopulmonary Complications
Time frame: 7 days
Any documented cardiopulmonary complications present upon chart review.
5 secondary outcomes
Anastomotic Leak Diagnosed Via Radiograph
Time frame: 7 days
Number of Participants With Renal Injury
Time frame: 7 days
Death
Time frame: 30 days
Length of Intensive Care Unit Stay
Time frame: 30 days
Hospital Length of Stay
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
George Guldan, MD principal investigator
Medical University of South Carolina
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 Therapy in people with Esophageal Cancer, run by Medical University of South Carolina 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 2 Mar 2021. 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?
Yes. Results are posted in the registry (first posted 2 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Cardiopulmonary Complications (time frame: 7 days). 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 2 Mar 2021.