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

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Sun Yat-sen University

Status

Completed

Conditions

Fluid Therapy

Treatments

Device: Stroke Volume Variation
Device: cardiac index

Study type

Interventional

Funder types

Other

Identifiers

NCT02841046
[2014]No.60

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

group cardiac index
Other group
Description:
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 .
Treatment:
Device: cardiac index
group Stroke Volume Variation
Experimental group
Description:
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 .
Treatment:
Device: Stroke Volume Variation

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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