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Clinical Trials/NCT02841046
NCT02841046
Completed
Not Applicable

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

First Affiliated Hospital, Sun Yat-Sen University0 sites50 target enrollmentJuly 27, 2016
ConditionsFluid Therapy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fluid Therapy
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Enrollment
50
Primary Endpoint
Number of Days Needed for Anal Exsufflation After Surgery
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
July 27, 2016
End Date
June 25, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Responsible Party
Principal Investigator
Principal Investigator

Lin Yang

Attending Physician

First Affiliated Hospital, Sun Yat-Sen University

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

Outcomes

Primary Outcomes

Number of Days Needed for Anal Exsufflation After Surgery

Time Frame: up to 8 weeks

record the number of days needed for anal exsufflation in non-severe patients after gastrointestinal tumor surgery

Secondary Outcomes

  • Oxygen Consumption(VO2)(during the surgery)
  • Oxygen Extraction Rate(ERO2)(during the surgery)
  • Number of Days in Hospital(up to 10 weeks)
  • the Incidence of Adverse Cardiovascular Events(during the surgery)
  • Oxygen Delivery(DO2)(during the surgery)

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