IVC Variation After VT Challenge to Predict Fluid Responsiveness

Can Respiratory Variation in Inferior Vena Cava Diameter After Tidal Volume Challenge Predict Fluid Responsiveness in Cardiac Surgical Patients With Mechanical Ventilation

The purpose of the study was to evaluate the efficacy of using the respiratory variation in inferior vena cava diameters as an index of fluid responsiveness after tidal volume challenge in mechanically ventilated patients after cardiac surgery.

Study Overview

• Status: Unknown
• Conditions: Cardiac Surgery; Mechanical Ventilation; Fluid Responsiveness; Fluid Challenge

Detailed Description

The "tidal volume challenge" is a novel test to predict fluid responsiveness in patents in shock, ventilated using low tidal volume without spontaneous breathing activity. The test involves transiently increasing tidal volume from 8 ml/kg PBW to 12 ml/kg PBW for one minute and observing the change in PPV or SVV. The aim of this study was to evaluate whether the respiratory variation in inferior vena cava diameter after tidal volume challenge can predict fluid responsiveness in cardiac surgical patients with mechanical ventilation

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • Zhongshan hospital, Fudan university
    • Contact: Luo Zhe, PhD; Phone Number: 3659 +86-21-64041990

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients after cardiac surgery

Description

Inclusion Criteria:

• acute circulatory failure (low blood pressure or urine output, tachycardia, or mottling)
• clinical signs of organ hypoperfusion (renal dysfunction or hyperlactatemia)

Exclusion Criteria:

• a contraindication to elevation of tidal volume
• evidence of cardiac arrhythmia
• left ventricular ejection fraction less than 50%
• echocardiographic examination that showed the existence of severe tricuspid or mitral regurgitation or right heart dysfunction
• intracardiac shunt
• pulmonary hypertension
• severe chronic obstructive pulmonary disease
• a contraindication to the passive leg raising (PLR) test
• air leakage through chest drains
• abdominal compartment syndrome
• portal hypertension
• pregnancy
• inability to perform ultrasonography

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
fluid responders; Patients whose stroke volume index increase by ≥15% in response to a 500-ml fluid bolus was defined as fluid responders.
fluid non-responders; Patients whose stroke volume index increase by <15% in response to a 500-ml fluid bolus was defined as fluid non-responders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fluid responsiveness	Patients will be classified as "fluid responders" if there is an increase in SV ≥15% after the fluid challenge, and the remaining patients are classified as "fluid non-responders"	after fluid challenge (30min)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inferior vena cava variation	Ultrasound equipment with convex probe will be used to measure IVC diameters of the patients in supine position.The IVC sagittal section is described with the probe in the area of subxiphoid. IVC diameters at the junction point of the IVC and right atrium (2cm caudal) are standardized measurement. The maximum anterior-posterior dimension came out from end-inspiration (IVCi, mm), whereas the minimum IVC diameter was shown in end-expiration (IVCe, mm). The IVC variation (IVCV) is calculated using the formula: IVCV (%) = (IVCi - IVCe) / [(IVCi+ IVCe) / 2] ×100%.	After tidal volume challenge (1 minute) and fluid challenge (30 minute)

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Tu Guo-wei, PhD, Fudan University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 3, 2018
• Primary Completion (ANTICIPATED): December 31, 2019
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: January 1, 2018
• First Submitted That Met QC Criteria: January 11, 2018
• First Posted (ACTUAL): January 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 1, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Fluid responsiveness; Cardiac surgery; Tidal volume challenge; Preload responsiveness; Functional hemodynamic monitoring; inferior vena cava variation
• Other Study ID Numbers: VIVC-TVC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No