Viewing Study NCT03485833


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Study NCT ID: NCT03485833
Status: UNKNOWN
Last Update Posted: 2018-04-02
First Post: 2018-03-24
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: End-expiratory and End-inspiratory Occlusion Tests to Predict Fluid Responsiveness
Sponsor: Shanghai Zhongshan Hospital
Organization:

Study Overview

Official Title: End-expiratory and End-inspiratory Occlusion Tests to Predict Fluid Responsiveness in Mechanically Ventilated Cardiac Surgical Patients
Status: UNKNOWN
Status Verified Date: 2018-03
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: EEOFR
Brief Summary: The purpose of the study is to verify the efficacy of using end-expiratory and end-inspiratory occlusion tests as an index of fluid responsiveness in mechanically ventilated patients with cardiac surgery.
Detailed Description: Patients with hypotension after anesthetic induction for cardiac surgery, who requires fluid resuscitation based on clinical judgement by the anesthesiologists are enrolled in this study. Patients are monitored by transesophageal echocardiography and FloTrac/Vigileo. Hemodynamic variables (heart rate, systolic blood pressure, diastolic blood pressure, mean artery pressure, central venous pressure, stroke volume variation, cardiac index, velocity time integral of the aorta etc) are measured at baseline, after end-expiratory occlusion (EEO) test, after end-inspiratory occlusion (EIO) test, after passive legs raising test, and after fluid challenge respectively. Responders are defined by an increase in velocity time integral over 15% after infusion of 5ml/kg of crystalloid solution.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: