IVC Variation After VT Challenge to Predict Fluid Responsiveness

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03397784
• Other study ID #: VIVC-TVC
• Status: Recruiting
• Phase: N/A
• First received: January 1, 2018
• Last updated: February 1, 2018
• Start date: February 3, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2018
• Source: Shanghai Zhongshan Hospital
• Contact: Luo Zhe, PhD
• Phone: 021-64041990
• Email: luo.zhe[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Fluid Challenge
• Fluid Responsiveness
• Mechanical Ventilation

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)