IVC Variation After VT Challenge to Predict Fluid Responsiveness

NCT ID: NCT03397784

Last Updated: 2018-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-03

Study Completion Date

2019-12-31

Brief Summary

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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

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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

Conditions

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Cardiac Surgery Fluid Challenge Fluid Responsiveness Mechanical Ventilation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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fluid responders

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tu Guo-wei, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Zhongshan Hospital, Fudan University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Luo Zhe, PhD

Role: CONTACT

021-64041990 ext. 3659

Tu Guo-wei, PhD

Role: CONTACT

021-64041990 ext. 3659

Facility Contacts

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Luo Zhe, PhD

Role: primary

+86-21-64041990 ext. 3659

Other Identifiers

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VIVC-TVC

Identifier Type: -

Identifier Source: org_study_id

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