Liver DiseasesNCT03169998
Effect of Goal-directed Fluid Therapy on Postoperative Complications
An observational study of Liver Diseases and Pancreas Disease, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
It has been known that the recent application of a goal-directed fluid therapy (GDFT) to the intraoperative fluid infusion in patients contributes to decreasing the prevalence of postoperative complications and shortening the length of study in the intensive care unit as well as hospital stay compared with… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Diseases, Pancreas Disease
- What is being tested?
- EV1000 platform
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 375 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2017to 31 Dec 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is to be conducted in patients scheduled with laparoscopic hepatobiliary or pancreatic surgery, who are at risk either for taking 2 hours or more in surgery or to lose blood of 1000 ml or more.
Who may be able to join
- Laparoscopic hepatobiliary or pancreatic surgery
Who cannot join
- Patients who do not consent to participation in the study
- Pregnant women, breastfeeding women
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: The Effect of Goal-directed Fluid Therapy on Postoperative Complications in Patients Undergoing Laparoscopic Hepatobiliary or Pancreatic Surgery
- It has been known that the recent application of a goal-directed fluid therapy (GDFT) to the intraoperative fluid infusion in patients contributes to decreasing the prevalence of postoperative complications and shortening the length of study in the intensive care unit as well as hospital stay compared with conventional methods.
- Laparoscopic surgery is in a trend that its application is being expanded recently, but there has been no report on the application of GDFT to laparoscopic surgery so far.
- To this end, this study aims to apply the intraoperative GDFT protocol in patients undergoing laparoscopic hepatobiliary or pancreatic surgery and to find out whether there is any difference in postoperative recovery and incidences of postoperative complications, by comparing with patients applied with the fluid therapy using existing conventional methods
- Conditions
- Liver Diseases, Pancreas Disease
- Being tested
- EV1000 platform
- Medical subject headings
- Liver Diseases, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV1000 platformDevice
a continuous arterial pressure monitoring was performed via EV1000/ FloTrac (Edwards Lifesciences, Irvine, CA, USA) (Fig 1) with the continuous monitoring of cardiac index (CI), stroke volume index (SVI) and stroke volume (SV).
| Study group | Role | What they receive |
|---|---|---|
| GDFT group | The fluid infusion is to be performed, in accordance with GDFT protocol, on the basis of cardiac index (CI), stroke volume index(SVI) and stroke volume (SV) in addition to invasively measured arterial pressure by Vigilio / FloTrac Monitor. Receives: Device: EV1000 platform | |
| Control group | Patients in whom the surgery was conducted without the use of EV1000/ FloTrac monitoring among those who had undergone laparoscopic hepatobiliary or pancreatic surgery in the past. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary complication
Measured: Postoperative 90 day
Wound complication
Measured: Postoperative 90 day
Acute kidney injury
Measured: Postoperative 90 day
Delirium
Measured: Postoperative 90 day
Deep vein thrombosis
Measured: Postoperative 90 day
Myocardiac infarction
Measured: Postoperative 90 day
Stroke
Measured: Postoperative 90 day
Sepsis
Measured: Postoperative 90 day
Urinary tract infection
Measured: Postoperative 90 day
Death
Measured: Postoperative 90 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 Jan 2017
- Primary completion30 Sep 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169998
- Sponsor's protocol ID
- EV1000
- Status last verified
- Feb 2022
- First submitted
- 24 May 2017
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Goal-directed Fluid Therapy on Postoperative Complications in Patients Undergoing Laparoscopic Hepatobiliary or Pancreatic Surgery
- ClinicalTrials.gov ID
- NCT03169998
- Acronym / sponsor ID
- EV1000
- Conditions
- Liver Diseases, Pancreas Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 30 May 2017 (actual)
- 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.
- It has been known that the recent application of a goal-directed fluid therapy (GDFT) to the intraoperative fluid infusion in patients contributes to decreasing the prevalence of postoperative complications and shortening the length of study in the intensive care unit as well as hospital stay compared with conventional methods.
- Laparoscopic surgery is in a trend that its application is being expanded recently, but there has been no report on the application of GDFT to laparoscopic surgery so far.
- To this end, this study aims to apply the intraoperative GDFT protocol in patients undergoing laparoscopic hepatobiliary or pancreatic surgery and to find out whether there is any difference in postoperative recovery and incidences of postoperative complications, by comparing with patients applied with the fluid therapy using existing conventional methods
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDFT group | – | Device: EV1000 platformThe fluid infusion is to be performed, in accordance with GDFT protocol, on the basis of cardiac index (CI), stroke volume index(SVI) and stroke volume (SV) in addition to invasively measured arterial pressure by Vigilio / FloTrac Monitor. |
| Control group | – | –Patients in whom the surgery was conducted without the use of EV1000/ FloTrac monitoring among those who had undergone laparoscopic hepatobiliary or pancreatic surgery in the past. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is to be conducted in patients scheduled with laparoscopic hepatobiliary or pancreatic surgery, who are at risk either for taking 2 hours or more in surgery or to lose blood of 1000 ml or more.
Key inclusion criteria (1 listed)
- Laparoscopic hepatobiliary or pancreatic surgery
Key exclusion criteria (2 listed)
- Patients who do not consent to participation in the study
- Pregnant women, breastfeeding women
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 |
|---|---|---|
| EV1000 platforma continuous arterial pressure monitoring was performed via EV1000/ FloTrac (Edwards Lifesciences, Irvine, CA, USA) (Fig 1) with the continuous monitoring of cardiac index (CI), stroke volume index (SVI) and stroke volume (SV). | Device | GDFT group |
Primary outcome
Pulmonary complication
Time frame: Postoperative 90 day
Wound complication
Time frame: Postoperative 90 day
Acute kidney injury
Time frame: Postoperative 90 day
Delirium
Time frame: Postoperative 90 day
Deep vein thrombosis
Time frame: Postoperative 90 day
Myocardiac infarction
Time frame: Postoperative 90 day
Stroke
Time frame: Postoperative 90 day
Sepsis
Time frame: Postoperative 90 day
Urinary tract infection
Time frame: Postoperative 90 day
Death
Time frame: Postoperative 90 day
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 22 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases and Pancreas Disease, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 2 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 22 Feb 2022. 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 South Korea. 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 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?
Pulmonary complication (time frame: Postoperative 90 day). The study lists 10 primary outcomes in all. 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 22 Feb 2022.