Clinical trial NCT05487924: Stroke Volume Variation- Guided Hemodynamic Therapy Versus Oxygen Extraction Ratio-guided Hemodynamic Therapy
Official title: Stroke Volume Variation- Guided Hemodynamic Therapy Versus Oxygen Extraction Ratio-guided Hemodynamic Therapy on Outcomes Following Laparoscopic Gastrointestinal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Goal-directed Fluid Therapy
Keywords: stroke volume variation
oxygen extraction ratio
goal-directed fluid therapy
laparoscopic gastrointestinal surgery
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Hospital
First posted: 2022-08-04
Enrollment: 610
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


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

Primary outcomes:
measure: postoperative complication
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Length of hospital stay
timeFrame: from the end of surgery until the date of discharge from hospital,assessed up to 30 days after surgery
measure: critical care-freedays
timeFrame: 30 days after surgery
measure: mortality
timeFrame: all-cause mortality at 30 days following surgery; all-cause mortality at 180 days following surgery
measure: postoperative recovery quality
timeFrame: 1, 3, 7 days after surgery
measure: time to first tolerate of an oral diet
timeFrame: from the end of surgery until the date of discharge from hospital,assessed up to 30 days after surgery
measure: time to first flatus
timeFrame: from the end of surgery until the date of discharge from hospital,assessed up to 30 days after surgery
Other outcomes:
Locations:
Study officials:
References: