Other Complications of EsophagostomyPPVNCT01933451
Outcome Study of Restrictive vs. Liberal Intraoperative Fluid Management Guided by PPV in Esophagectomy
A study testing Intraoperative fluid therapy in people with Other Complications of Esophagostomy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to determine whether intraoperative restrictive fluid management guided by pulse pressure variation produces a better effect on the postoperative lung function, kidney function, inflammatory response and short-term outcome after esophagectomy and reconstruction. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Other Complications of Esophagostomy
- What is being tested?
- Intraoperative fluid therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2013to Aug 2013
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing esophagectomy and reconstruction
Who cannot join
- ASA score >= 3, (American Society of Anesthesiologist physical status classification system)
- arrythmia, atrial fibrillation
- lung diseases, such as COPD (chronic obstructive pulmonary disease); lung function test showed moderate to severe ventilation defect
- plasma creatinine level above 1.5 mg/dl
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Anesthesiology, National Taiwan University Hospital
Taipei, 100
About this study
Official title: Postoperative Lung Function, Kidney Function, Inflammatory Response and Short-term Outcome After Esophagectomy and Reconstruction: Intraoperative Fluid Management Controlled With Lower and Higher Pulse Pressure Variation
The purpose of this study is to determine whether intraoperative restrictive fluid management guided by pulse pressure variation produces a better effect on the postoperative lung function, kidney function, inflammatory response and short-term outcome after esophagectomy and reconstruction.
Read the detailed description
Measurements: intraoperative Lung injury score, Lung water index, Pulmonary vascular Permeability Index Measurements: intraoperative and postoperative Plasma creatine, C reactive protein (CRP), lactate, Neutrophil gelatinase-associated lipocalin (NGAL), Interleukin-6 (IL-6), Interleukin-8 (IL-8)
- Conditions
- Other Complications of Esophagostomy
- Being tested
- Intraoperative fluid therapy
- Keywords
- fluid therapy, Intraoperative care, Patient Outcome Assessment, pulse pressure variation, restrictive fluid therapy, goal-directed fluid therapy, esophagectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative fluid therapyOther
Intraoperative fluid therapy is directed by pulse pressure variation to a setting value, above 18% or below 13%.
| Study group | Role | What they receive |
|---|---|---|
| Restrictive intraoperative fluid therapy | Experimental | To Keep intraoperative pulse pressure variation above 18%. Receives: Other: Intraoperative fluid therapy |
| Liberal intraoperative fluid therapy | Other | To keep intraoperative pulse pressure variation below 13%. Receives: Other: Intraoperative fluid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative lung function, kidney function, inflammatory response
plasma creatinine, CRP, lactate, NGAL, IL-6, IL-8
Measured: from introperative to postoperative day 2
Secondary outcomes (1)
postoperative short-term outcome
Respiratory complication, cardiovascular complication, acute renal failure, another complications
Measured: the duration of hospital stay, about 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: The grant for this study was not allowed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Complications of EsophagostomyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ya-Uyng Cheng, MD. PHD., Principal investigator, chengyj@ntu.edu.tw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933451
- Sponsor's protocol ID
- 201211078RIB
- Acronym
- PPV
- Status last verified
- Mar 2013
- First submitted
- 19 Mar 2013
- Last updated
- 2 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Lung Function, Kidney Function, Inflammatory Response and Short-term Outcome After Esophagectomy and Reconstruction: Intraoperative Fluid Management Controlled With Lower and Higher Pulse Pressure Variation
- ClinicalTrials.gov ID
- NCT01933451
- Acronym / sponsor ID
- PPV / 201211078RIB
- Conditions
- Other Complications of Esophagostomy
- Keywords
- fluid therapy, Intraoperative care, Patient Outcome Assessment, pulse pressure variation, restrictive fluid therapy, goal-directed fluid therapy, esophagectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The grant for this study was not allowed.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 2 Sep 2013 (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 this study is to determine whether intraoperative restrictive fluid management guided by pulse pressure variation produces a better effect on the postoperative lung function, kidney function, inflammatory response and short-term outcome after esophagectomy and reconstruction.
Detailed description
Measurements: intraoperative Lung injury score, Lung water index, Pulmonary vascular Permeability Index Measurements: intraoperative and postoperative Plasma creatine, C reactive protein (CRP), lactate, Neutrophil gelatinase-associated lipocalin (NGAL), Interleukin-6 (IL-6), Interleukin-8 (IL-8)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restrictive intraoperative fluid therapy | Experimental | Other: Intraoperative fluid therapyTo Keep intraoperative pulse pressure variation above 18%. |
| Liberal intraoperative fluid therapy | Other | Other: Intraoperative fluid therapyTo keep intraoperative pulse pressure variation below 13%. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing esophagectomy and reconstruction
Key exclusion criteria (4 listed)
- ASA score >= 3, (American Society of Anesthesiologist physical status classification system)
- arrythmia, atrial fibrillation
- lung diseases, such as COPD (chronic obstructive pulmonary disease); lung function test showed moderate to severe ventilation defect
- plasma creatinine level above 1.5 mg/dl
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 |
|---|---|---|
| Intraoperative fluid therapyIntraoperative fluid therapy is directed by pulse pressure variation to a setting value, above 18% or below 13%. | Other | Liberal intraoperative fluid therapy, Restrictive intraoperative fluid therapy |
Primary outcome
postoperative lung function, kidney function, inflammatory response
Time frame: from introperative to postoperative day 2
plasma creatinine, CRP, lactate, NGAL, IL-6, IL-8
1 secondary outcome
postoperative short-term outcome
Time frame: the duration of hospital stay, about 4 weeks
Results and safety
The study was stopped early (reason given: The grant for this study was not allowed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2013.
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-Uyng Cheng, MD. PHD. principal investigator
chengyj@ntu.edu.tw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative fluid therapy in people with Other Complications of Esophagostomy, run by National Taiwan University Hospital at 1 site in Taiwan.
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 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 Sep 2013. 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 Taiwan. 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 stopped early (reason given: The grant for this study was not allowed.). Results are not available in the source record.
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?
postoperative lung function, kidney function, inflammatory response (time frame: from introperative to postoperative day 2). 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 Sep 2013.