N/A N=50 Randomized Single-blind Treatment

The Effect of Goal-directed Therapy Guided by Stroke Volume Variation and Cardiac Index in Non-severe Surgical Patients

Fluid Therapy

Bottom Line

View on ClinicalTrials.gov: NCT02841046 ↗

Enrolled (actual)

Serious AEs

12.0%

Results posted

Mar 2020

Primary outcome: Primary: Number of Days Needed for Anal Exsufflation After Surgery — 3.8; 2.7 days

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: cardiac index (Device); Stroke Volume Variation (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: First Affiliated Hospital, Sun Yat-Sen University
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Days Needed for Anal Exsufflation After Surgery	3.8; 2.7	—
SECONDARY the Incidence of Adverse Cardiovascular Events	—	—
SECONDARY Oxygen Delivery（DO2）	—	—
SECONDARY Oxygen Consumption（VO2）	—	—
SECONDARY Oxygen Extraction Rate（ERO2）	—	—
SECONDARY Number of Days in Hospital	—	—

Summary

To evaluate the application of fluid-infusion therapy with the combination of stroke volume variation (SVV) and cardiac index (CI) as the primary judgment in non-severe patients underwent resection of gastrointestinal tumor. Fifty patients (ASA Ⅰ-Ⅱ, 26-55 years old, cardiac functional gradingⅠ) scheduled for gastrointestinal tumor surgery were divided into two groups randomly: group C with CI as the primary judgment and group S with the combination of SVV and CI as the primary judgment.

Eligibility Criteria

Inclusion Criteria

American Society of Anesthesiologists (ASA) physical status of grade I-II
Cardiac function classification by NYHA of grade I
without high risk factors according to the revised Lee cardiac risk index:
High-risk type of surgery
Ischemic heart disease
History of congestive heart failure
History of cerebrovascular disease
Insulin therapy for diabetes
Preoperative serum creatinine > 2.0 mg/dl
undergoing gastrointestinal tumor surgery

Exclusion Criteria

Patients under 18 years or above 55 years
patients with severe aortic regurgitation
patients with permanent cardiac arrhythmias
patients with intra-aortic balloon pump
patients with severe pulmonary disease
patients with hepatic or renal dysfunction
patients undergoing emergency surgery

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02841046). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.