Goal-directed Fluid TherapyNCT03940144
Effect of SVV-guided Fluid Therapy on Outcomes After Major Abdominal Surgery
A study testing the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device in people with Goal-directed Fluid Therapy, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
The investigators conduct this randomized assessor-blinded controlled trial to evaluate the effect of SVV-guided fluid therapy on postoperative morbidity and mortality in comparison with conventional fluid therapy after major abdominal surgery. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Goal-directed Fluid Therapy
- What is being tested?
- the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2019to 2 Feb 2021
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients (aged 18 to 80 years)
- ASA I~III
- BMI:18~30kg／m2
- Procedures were considered major if listed for resection of gastrointestinal, gynecologic, and urologic cancer with tumor debulking, staging or reconstruction with a risk for significant surgical blood loss
Who cannot join
- Patients under 18 years,
- pregnant or lactating woman
- patients with esophageal or gastric surgical history
- co-existing congestive heart failure; chronic lung disease; or renal or hepatic dysfunction (creatinine >50 % or liver enzymes >50 % of normal values), and arrhythmias-operative down staging using chemotherapy and/or radiation therapy
- patients undergoing emergency surgery
- patients with co-existing congestive heart failure; chronic lung disease; or renal or hepatic dysfunction (creatinine >50 % or liver enzymes >50 % of normal values), and arrhythmias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Department of Anesthesiology, Beijing Tong Ren Hospital Capital Medical University
The investigators conduct this randomized assessor-blinded controlled trial to evaluate the effect of SVV-guided fluid therapy on postoperative morbidity and mortality in comparison with conventional fluid therapy after major abdominal surgery. Half of participants will receive GDFT perioperatively, and the others will receive conventional fluid therapy
Read the detailed description
Perioperative fluid management has been recognized as an important factor with an impact on postoperative recovery following major abdominal surgery. However, the optimal fluid management is difficult to achieve using standard parameters (e.g., heart rate [HR], blood pressure [BP], central venous pressure[CVP], or urine output) that poorly estimate preload and preload responsiveness. Goal-directed fluid therapy (GDFT) was proposed by introducing different hemodynamic variables into a dynamic perspective of individual fluid loading with or without vasoactive substances to reach predefined goal of optimal preload and/or oxygen delivery.There have been increasing numbers of studies evaluating the effect of perioperative GDFT on postoperative recovery following major abdominal surgery. However, the evidence for the beneficial effect of GDFT on postoperative recovery remains inconsistent.
- Conditions
- Goal-directed Fluid Therapy
- Being tested
- the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo deviceDevice
Stroke volume variation (SVV)-guided fluid therapy
| Study group | Role | What they receive |
|---|---|---|
| goal-directed fluid therapy | Experimental | Stroke Volume variation (SVV)-guided fluid therapy Receives: Device: the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device |
| Conventional fluid therapy | Active comparator | Conventional fluid therapy such as CVP and MAP guided fluid therapy Receives: Device: the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
from the end of surgery to discharge from hospital
Measured: from the end of surgery to discharge from hospital up to 30 days after surgery
GI function
number of participants with I-FEED score >6
Measured: from the end of surgery to 30 days after surgery
Secondary outcomes (4)
mortality
death after surgery
Measured: from the end of surgery to 1 year after surgery
postoperative pain score
VAS for pain :0 no pain and 10 for worst pain
Measured: 1 day, 3 days and 5 days after surgery
postoperative recovery quality
QoR-15 :quality of recovery score : 0 worst recovery quality and 150 for best recovery
Measured: 1 day, 3 days and 5 days after surgery
Postoperative complications
number of any complications after surgery
Measured: from end of surgery to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start15 May 2019
- Primary completion31 Jan 2021
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Goal-directed Fluid TherapyStudies of the same condition, open and under way.
- More trials run by Beijing Tongren 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
- Model description
- goal-directed fluid therapy guided by stroke volume variation and cardiac index using FloTrac/Vigileo monitor
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YANXIA SUN, Beijing Tongren Hospital
- Investigators
- Yanxia Sun, M.D., Principal investigator, Beijing Tong Ren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940144
- Sponsor's protocol ID
- PX2018007
- Status last verified
- Mar 2023
- First submitted
- 25 Apr 2019
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun Y, Liang X, Chai F, Shi D, Wang Y. Goal-directed fluid therapy using stroke volume variation on length of stay and postoperative gastrointestinal function after major abdominal surgery-a randomized controlled trial. BMC Anesthesiol. 2023 Dec 4;23(1):397. doi: 10.1186/s12871-023-02360-1.
PubMed 38049713
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Anesthesiology, Beijing Tong Ren Hospital Capital Medical University
- ClinicalTrials.gov ID
- NCT03940144
- Acronym / sponsor ID
- PX2018007
- Conditions
- Goal-directed Fluid Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 7 May 2019 (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.
The investigators conduct this randomized assessor-blinded controlled trial to evaluate the effect of SVV-guided fluid therapy on postoperative morbidity and mortality in comparison with conventional fluid therapy after major abdominal surgery. Half of participants will receive GDFT perioperatively, and the others will receive conventional fluid therapy
Detailed description
Perioperative fluid management has been recognized as an important factor with an impact on postoperative recovery following major abdominal surgery. However, the optimal fluid management is difficult to achieve using standard parameters (e.g., heart rate [HR], blood pressure [BP], central venous pressure[CVP], or urine output) that poorly estimate preload and preload responsiveness. Goal-directed fluid therapy (GDFT) was proposed by introducing different hemodynamic variables into a dynamic perspective of individual fluid loading with or without vasoactive substances to reach predefined goal of optimal preload and/or oxygen delivery.There have been increasing numbers of studies evaluating the effect of perioperative GDFT on postoperative recovery following major abdominal surgery. However, the evidence for the beneficial effect of GDFT on postoperative recovery remains inconsistent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- goal-directed fluid therapy guided by stroke volume variation and cardiac index using FloTrac/Vigileo monitor
| Arm | Type | Receives |
|---|---|---|
| goal-directed fluid therapy | Experimental | Device: the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo deviceStroke Volume variation (SVV)-guided fluid therapy |
| Conventional fluid therapy | Active comparator | Device: the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo deviceConventional fluid therapy such as CVP and MAP guided fluid therapy |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (aged 18 to 80 years)
- ASA I~III
- BMI:18~30kg／m2
- Procedures were considered major if listed for resection of gastrointestinal, gynecologic, and urologic cancer with tumor debulking, staging or reconstruction with a risk for significant surgical blood loss
Key exclusion criteria (6 listed)
- Patients under 18 years,
- pregnant or lactating woman
- patients with esophageal or gastric surgical history
- co-existing congestive heart failure; chronic lung disease; or renal or hepatic dysfunction (creatinine >50 % or liver enzymes >50 % of normal values), and arrhythmias-operative down staging using chemotherapy and/or radiation therapy
- patients undergoing emergency surgery
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 |
|---|---|---|
| the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo deviceStroke volume variation (SVV)-guided fluid therapy | Device | Conventional fluid therapy, goal-directed fluid therapy |
Primary outcome
Length of hospital stay
Time frame: from the end of surgery to discharge from hospital up to 30 days after surgery
from the end of surgery to discharge from hospital
GI function
Time frame: from the end of surgery to 30 days after surgery
number of participants with I-FEED score >6
4 secondary outcomes
mortality
Time frame: from the end of surgery to 1 year after surgery
postoperative pain score
Time frame: 1 day, 3 days and 5 days after surgery
postoperative recovery quality
Time frame: 1 day, 3 days and 5 days after surgery
Postoperative complications
Time frame: from end of surgery to 30 days after surgery
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 9 Mar 2023.
- Derived from this study: PubMed 38049713Sun Y, Liang X, Chai F, Shi D, Wang Y. Goal-directed fluid therapy using stroke volume variation on length of stay and postoperative gastrointestinal function after major abdominal surgery-a randomized controlled trial. BMC Anesthesiol. 2023 Dec 4;23(1):397. doi: 10.1186/s12871-023-02360-1.
- 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.
Yanxia Sun, M.D. principal investigator
Beijing Tong Ren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device in people with Goal-directed Fluid Therapy, run by Beijing Tongren Hospital at 1 site in China.
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 4 inclusion and 6 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 9 Mar 2023. 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 China. 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?
Length of hospital stay (time frame: from the end of surgery to discharge from hospital up to 30 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03940144, which also lists 1 linked publication.
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 9 Mar 2023.