Overview

This trial is active, not recruiting.

Condition fluid therapy
Treatments cardiac index, stroke volume variation
Sponsor First Affiliated Hospital, Sun Yat-Sen University
Start date July 2016
End date October 2016
Trial size 50 participants
Trial identifier NCT02841046, [2014]No.60

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Other)
the treatment scheme of goal-directed fluid therapy(GDFT) use cardiac index(CI) as the primary judgment in group cardiac index,Patients in group cardiac index received a therapy with the goal of CI was no less than 2.5L•min-1•m-2 .
cardiac index
group cardiac index(CI) and group Stroke Volume Variation(SVV) are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group cardiac index with CI as the primary judgment.
(Experimental)
the treatment scheme of goal-directed fluid therapy(GDFT) use Stroke Volume Variation(SVV)and cardiac index(CI)as the primary judgment in group Stroke Volume Variation,Patients in group Stroke Volume Variation received a therapy with SVV was less than 12% and CI was no less than 2.5L•min-1•m-2 .
stroke volume variation
group cardiac index(CI) and group Stroke Volume Variation(SVV) are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group Stroke Volume Variation with the combination of SVV and CI as the primary judgment.

Primary Outcomes

Measure
Number of days needed for anal exsufflation after surgery
time frame: up to 8 weeks

Secondary Outcomes

Measure
the incidence of adverse cardiovascular events
time frame: during the surgery
oxygen delivery(DO2)
time frame: during the surgery
oxygen consumption(VO2)
time frame: during the surgery
oxygen extraction rate(ERO2)
time frame: during the surgery
Number of Days in Hospital
time frame: up to 10 weeks

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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: 1. High-risk type of surgery 2. Ischemic heart disease 3. History of congestive heart failure 4. History of cerebrovascular disease 5. Insulin therapy for diabetes 6. 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

Additional Information

Official title The Application of Goal-directed Therapy With the Combination of Stroke Volume Variation and Cardiac Index as the Primary Judgment in Non-severe Patients Underwent Gastrointestinal Tumor Surgery
Description 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. Methods: Fifty patients (ASA Ⅰ-Ⅱ, 18-55 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. Patients in group C received a therapy with the goal of CI was no less than 2.5L•min-1•m-2 while SVV was less than 12% and CI was no less than 2.5L•min-1•m-2 in group S. Indexes including MAP、HR、CVP、CI、SVV were recorded at the moment after anaesthetized (T1), when skin was incised (T2), when the intestina was anastomosed (T3) and after the abdomen was closed (T4). SaO2、ScvO2 and plasma lactic were determined at T1 and T4 and DO2,VO2 and ERO2 during the surgery were calculated .The volume of fluid, vasoactive drugs use, the incidence of adverse cardiovascular events, the convalescence of intestinal peristalsis, hospital stay and postoperative complications were recorded.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by First Affiliated Hospital, Sun Yat-Sen University.