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

Goal-directed Fluid Therapy Clinical Trial

Official title:

Stroke Volume Variation- Guided Hemodynamic Therapy Versus Oxygen Extraction Ratio-guided Hemodynamic Therapy on Outcomes Following Laparoscopic Gastrointestinal Cancer Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05487924
• Other study ID #: BJH-005
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 30, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 610
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Goal-directed Fluid Therapy
• Stroke

Intervention

Other:
• SVV-GDHT
GDHT guided by SVV using Flotra/Vigileo monitor
• O2ER-GDHT
GDHT guided by O2ER
• conventional care
conventional fluid therapy without GDHT

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Tongren Hospital	Beijing Hospital

Outcome

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