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Trial Title:
Stroke Volume Variation- Guided Hemodynamic Therapy Versus Oxygen Extraction Ratio-guided Hemodynamic Therapy
NCT ID:
NCT05487924
Condition:
Goal-directed Fluid Therapy
Conditions: Official terms:
Stroke
Conditions: Keywords:
stroke volume variation
oxygen extraction ratio
goal-directed fluid therapy
laparoscopic gastrointestinal surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
SVV-GDHT
Description:
GDHT guided by SVV using Flotra/Vigileo monitor
Arm group label:
SVV-GDHT
Intervention type:
Other
Intervention name:
O2ER-GDHT
Description:
GDHT guided by O2ER
Arm group label:
O2ER-GDHT
Intervention type:
Other
Intervention name:
conventional care
Description:
conventional fluid therapy without GDHT
Arm group label:
conventional care
Summary:
The FloTrac/Vigileo is a minimal invasive device assessing flow based hemodynamic
parameters by pulse contour analysis based on the radial artery pressure signal. This
method gained popularity as it is minimally invasive compared to esophageal Doppler or
pulmonary artery catheter insertion and provides continuous beat-to-beat data. The
previous study with 110 patients found that that GDHT guided by stroke volume variation
(SVV) using the FloTrac/Vigileo device was associated with a reduced length of hospital
stay and a lower incidence of POGD in major abdominal oncological surgery. However, no
difference was found in the incidence of postoperative complications between the two
groups, lack of statistical power could be a limitation to demonstrate the true
association. Therefore, further prospective trials are needed to address this issue.
The use of early and efficient therapeutic strategies able to detect and to treat
potential triggers of organ failures, such as tissue hypoperfusion, is particularly
important. If hypoperfusion is not adequately managed, tissue hypoxia could occur,
resulting from an impairment of the adaptive mechanisms of myocardial contractile
function, under the influence of inflammatory mediators, and the peripheral tissues will
then increase their oxygen extraction (O2ER). AS such, GDHT guided by O2ER may be
appropriate to monitor GDHT strategies because it reflects the balance between oxygen
delivery and consumption.
Therefore, the investigators performed this single-center, randomized, controlled trial
to investigate whether GDHT guided by SVV using FloTrac/Vigileo monitor and GDHT guided
by O2ER would reduce incidence of postoperative complication and shorten the length of
hospital stay, compared with a standard conventional fluid therapy in low-to-moderate
risk patients undergoing major laparoscopic gastrointestinal oncological surgery.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 18~80 years
2. ASA I~III
3. Patients undergoing elective major laparoscopic gastrointestinal oncological
surgery.Procedures were considered major if listed for resection cancer with tumor
debulking, staging or reconstruction with a risk for significant surgical blood
loss.
Exclusion Criteria:
1. co-existing congestive heart failure; chronic lung disease; or renal or hepatic
dysfunction (creatinine >50 % or liver enzymes >50 % of normal values), and
arrhythmias.
2. less than 18 years
3. pregnant or lactating woman
4. patients undergoing emergency surgery
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
December 30, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Beijing Tongren Hospital
Agency class:
Other
Collaborator:
Agency:
Beijing Hospital
Agency class:
Other
Source:
Beijing Tongren Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05487924
