IVC Variation After VT Challenge to Predict Fluid Responsiveness

NCT03397784 | Unknown DMC

• 1 other identifier: VIVC-TVC
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery; Fluid Challenge; Fluid Responsiveness; Mechanical Ventilation

Keywords

Tidal volume challenge; Fluid responsiveness; Preload responsiveness; Functional hemodynamic monitoring; Cardiac surgery; inferior vena cava variation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• inferior vena cava variation

  After tidal volume challenge (1 minute) and fluid challenge (30 minute)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients after cardiac surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, 200032, China

RECRUITING

Study Officials

• Tu Guo-wei, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luo Zhe, PhD

CONTACT

021-64041990; luo.zhe@zs-hospital.sh.cn

Tu Guo-wei, PhD

CONTACT

021-64041990; tu.guowei@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2018
• First Posted: January 12, 2018
• Study Start: February 3, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 5, 2018

Record last verified: 2018-01

Locations

CN (1)