Stroke Volume Variation- Guided Hemodynamic Therapy Versus Oxygen Extraction Ratio-guided Hemodynamic Therapy

Not Applicable

Not yet recruiting

• Conditions: Goal-directed Fluid Therapy

• Registration Number: NCT05487924
• Lead Sponsor: Beijing Tongren Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-24
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-04
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12
• Study Start: 2023-12-30
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 610

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
postoperative complication	30 days after surgery	the number of patients with predefined moderate or major postoperative complications (pulmonary embolism, myocardial ischemia or infarction, arrhythmia, cardiac or respiratory arrest, limb or digital ischemia, cardiogenic pulmonary edema, acute respiratory distress syndrome, gastrointestinal bleeding, bowel infarction, anastomotic breakdown, paralytic ileus, acute psychosis, stroke, acute kidney injury, infection \[source uncertain\], urinary tract infection, surgical site infection, organ/space infection, bloodstream infection, nosocomial pneumonia, and postoperative hemorrhage

Secondary Outcome Measures

Name	Time	Method
mortality	all-cause mortality at 30 days following surgery; all-cause mortality at 180 days following surgery	all cause mortality
Length of hospital stay	from the end of surgery until the date of discharge from hospital,assessed up to 30 days after surgery	Length of stay was determined by the period from completion of surgery to discharge
critical care-freedays	30 days after surgery	numberof days alive and not in critical care
time to first tolerate of an oral diet	from the end of surgery until the date of discharge from hospital,assessed up to 30 days after surgery	time from the end of surgery and first tolerate of an oral diet
postoperative recovery quality	1, 3, 7 days after surgery	QoR15, 0 :not at all , 10: most of time
time to first flatus	from the end of surgery until the date of discharge from hospital,assessed up to 30 days after surgery	duration between the end of surgery and first flatus