AnesthesiaNCT02961140
Different Anesthetic Managements of Esophageal Resection and Reconstruction
A study testing Cardiac Output Maximization and Cardiac Output Normalization in people with Anesthesia and Esophagus Cancer, run by National Taiwan University Hospital.
Trial summary
Anesthetic management and fluid therapy is crucial in esophageal resection and reconstruction, which is associated with high incidence of postoperative morbidity and mortality. This study aims to investigate the effect of goal directed fluid management on the postoperative outcome of esophageal resection and… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Anesthesia, Esophagus Cancer, Postoperative Complications
- What is being tested?
- Cardiac Output Maximization and Cardiac Output Normalization
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Nov 2019
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed as esophageal cancer
- Scheduled for minimally invasive esophageal resection and reconstruction
Who cannot join
- End-stage organ dysfunction, including heart failure, hepatic failure, renal failure
- Arrhythmia
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effects of Different Anesthetic Managements on Inflammation, Oxidative Injuries, and Major Organ Complications: a Prospective Investigations on Esophageal Reconstruction and Intraoperative Shock
Anesthetic management and fluid therapy is crucial in esophageal resection and reconstruction, which is associated with high incidence of postoperative morbidity and mortality. This study aims to investigate the effect of goal directed fluid management on the postoperative outcome of esophageal resection and reconstruction.
Read the detailed description
Anesthetic management and fluid therapy is crucial in esophageal resection and reconstruction, which is associated with high incidence of postoperative morbidity and mortality. Excessive fluid administration may result in pulmonary complication, while extremely hypovolemia may lead to shock, circulatory dysfunction, and renal damage. Little is known about fluid status will have impact on anastomotic leakage. Goal-directed fluid therapy has shown to benefit perioperative outcome in major abdominal surgery. This study aims to investigate the effect of goal directed fluid management on the postoperative outcome of esophageal resection and reconstruction.
- Conditions
- Anesthesia, Esophagus Cancer, Postoperative Complications
- Being tested
- Cardiac Output Maximization, Cardiac Output Normalization
- Keywords
- Outcome
- Medical subject headings
- Esophageal Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Output MaximizationOther
According to Frank-Starling law, the investigator will administer Voluven 6% 250 mL every 5 minute until stroke volume maximized (stabilized for 20 minutes), and maintain cardiac index and stroke volume variation during the whole operation.
Cardiac Output NormalizationOther
The investigator will administer intravenous fluids to keep cardiac index (CI) ≥ 2.2, and maintain CI and stroke volume variation during the whole operation.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Output Maximization | Experimental | maximize stroke volume, and maintain cardiac index and stroke volume variation during the whole operation Receives: Other: Cardiac Output Maximization |
| Cardiac Output Normalization | Active comparator | keep cardiac index (CI) ≥ 2.2, and maintain CI and stroke volume variation during the whole operation Receives: Other: Cardiac Output Normalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative complication
Perioperative mortality, anastomotic leakage, pneumonia, respiratory failure, renal dysfunction, and surgical site infection
Measured: 1 month
Secondary outcomes (2)
Intraoperative hemodynamic stability
Incidence of intraoperative shock, use of vasopressor or inotropic agents
Measured: 1 day
Length of stay
Intensive care unit length of stay and hospital stay
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2018 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- Ya-jung Cheng, M.D., Ph.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961140
- Sponsor's protocol ID
- 201512052RINB
- Status last verified
- Nov 2016
- First submitted
- 6 Nov 2016
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Anesthetic Managements on Inflammation, Oxidative Injuries, and Major Organ Complications: a Prospective Investigations on Esophageal Reconstruction and Intraoperative Shock
- ClinicalTrials.gov ID
- NCT02961140
- Acronym / sponsor ID
- 201512052RINB
- Conditions
- Anesthesia, Esophagus Cancer, Postoperative Complications
- Keywords
- Outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- Nov 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 10 Nov 2016 (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.
Anesthetic management and fluid therapy is crucial in esophageal resection and reconstruction, which is associated with high incidence of postoperative morbidity and mortality. This study aims to investigate the effect of goal directed fluid management on the postoperative outcome of esophageal resection and reconstruction.
Detailed description
Anesthetic management and fluid therapy is crucial in esophageal resection and reconstruction, which is associated with high incidence of postoperative morbidity and mortality. Excessive fluid administration may result in pulmonary complication, while extremely hypovolemia may lead to shock, circulatory dysfunction, and renal damage. Little is known about fluid status will have impact on anastomotic leakage. Goal-directed fluid therapy has shown to benefit perioperative outcome in major abdominal surgery. This study aims to investigate the effect of goal directed fluid management on the postoperative outcome of esophageal resection and reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac Output Maximization | Experimental | Other: Cardiac Output Maximizationmaximize stroke volume, and maintain cardiac index and stroke volume variation during the whole operation |
| Cardiac Output Normalization | Active comparator | Other: Cardiac Output Normalizationkeep cardiac index (CI) ≥ 2.2, and maintain CI and stroke volume variation during the whole operation |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed as esophageal cancer
- Scheduled for minimally invasive esophageal resection and reconstruction
Key exclusion criteria (3 listed)
- End-stage organ dysfunction, including heart failure, hepatic failure, renal failure
- Arrhythmia
- Pregnancy
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 |
|---|---|---|
| Cardiac Output MaximizationAccording to Frank-Starling law, the investigator will administer Voluven 6% 250 mL every 5 minute until stroke volume maximized (stabilized for 20 minutes), and maintain cardiac index and stroke volume variation during the whole operation. | Other | Cardiac Output Maximization |
| Cardiac Output NormalizationThe investigator will administer intravenous fluids to keep cardiac index (CI) ≥ 2.2, and maintain CI and stroke volume variation during the whole operation. | Other | Cardiac Output Normalization |
Primary outcome
Incidence of postoperative complication
Time frame: 1 month
Perioperative mortality, anastomotic leakage, pneumonia, respiratory failure, renal dysfunction, and surgical site infection
2 secondary outcomes
Intraoperative hemodynamic stability
Time frame: 1 day
Length of stay
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Ya-jung Cheng, M.D., Ph.D principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Output Maximization and Cardiac Output Normalization in people with Anesthesia and Esophagus Cancer, run by National Taiwan University Hospital.
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 3 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: status not confirmed, as of the sponsor's last update on 10 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya-jung Cheng, M.D., Ph.D (+886-2-23123456 ext. 65517, chengyj@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative complication (time frame: 1 month). 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 10 Nov 2016.