IVC Variation After VT Challenge to Predict Fluid Responsiveness

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

• Registration Number: NCT03397784
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2018-01
• Study First Submitted: 2018-01-01
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-12
• Last Update Submitted: 2018-02-01
• Study Start: 2018-02-03
• Last Update Posted: 2018-02-05
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fluid responsiveness	after fluid challenge (30min)	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"

Secondary Outcome Measures

Name	Time	Method
inferior vena cava variation	After tidal volume challenge (1 minute) and fluid challenge (30 minute)	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%.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China