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TerminatedNCT01933451PPVUpdated Sep 2, 2013

Outcome Study of Restrictive vs. Liberal Intraoperative Fluid Management Guided by PPV in Esophagectomy

An interventional study of Intraoperative fluid therapy in Other Complications of Esophagostomy, sponsored by National Taiwan University Hospital. Terminated at 1 site in Taiwan. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-09-02.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Supportive care

Why this study was terminated
The grant for this study was not allowed.
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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 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)

02

Conditions studied

  • Other Complications of Esophagostomy

Keywords

  • fluid therapy
  • Intraoperative care
  • Patient Outcome Assessment
  • pulse pressure variation
  • restrictive fluid therapy
  • goal-directed fluid therapy
  • esophagectomy
03

In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,609 studies on the registry; 574 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients undergoing esophagectomy and reconstruction

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Restrictive intraoperative fluid therapy

    To Keep intraoperative pulse pressure variation above 18%.

    Other: Intraoperative fluid therapy

  • Other
    Liberal intraoperative fluid therapy

    To keep intraoperative pulse pressure variation below 13%.

    Other: Intraoperative fluid therapy

Interventions

  • OtherIntraoperative fluid therapy

    Intraoperative fluid therapy is directed by pulse pressure variation to a setting value, above 18% or below 13%.

06

What researchers measure

Primary outcomes

  1. postoperative lung function, kidney function, inflammatory response

    plasma creatinine, CRP, lactate, NGAL, IL-6, IL-8

    Time frame: from introperative to postoperative day 2

Secondary outcomes

  1. postoperative short-term outcome

    Respiratory complication, cardiovascular complication, acute renal failure, another complications

    Time frame: the duration of hospital stay, about 4 weeks

07

Study locations

1 site
  • Department of Anesthesiology, National Taiwan University Hospital
    Taipei, 100, Taiwan
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2013, a primary completion of Aug 2013 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2013
First posted
Sep 2, 2013
Start
Mar 2013
Primary completionActual
Aug 2013
CompletionActual
Aug 2013
Last update
Sep 2, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01933451
Responsible party
Sponsor
First posted
Sep 2, 2013
Start date
Mar 2013
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Sep 2, 2013

Study contacts

Ya-Uyng Cheng, MD. PHD.
principal investigator · chengyj@ntu.edu.tw

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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