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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 November 2021 |
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Main ID: |
NCT03225378 |
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Date of registration:
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20/07/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Changes in PPV Induced by PLR Test to Predict Fluid Responsiveness in ICU
VPP-ImPRoVE |
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Scientific title:
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Changes in Pulse Pressure Variations Induced by Passive Leg Raising Test to Predict Fluid Responsiveness in ICU |
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Date of first enrolment:
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September 21, 2017 |
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Target sample size:
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286 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03225378 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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France
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Contacts
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Name:
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Jihad MALLAT, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Arras |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Mechanically ventilated patients
- Patients in whom the physician decides to perform a fluid challenge based on the
presence of one of the following criteria:
(1) systolic arterial pressure <90 mmHg, mean arterial pressure <65 mmHg, or the need
for vasopressor infusion; (2) skin mottling; (3) urine output <0.5 mL/Kg/h for more
than or equal to 2 hours; (4) lactate concentrations > 2 mmol/L
- Patients in whom the physician decides to perform a PLR test to predict fluid
responsiveness
- Arterial catheter should be in place for invasive monitoring of arterial pressure and
PPV
Non inclusion Criteria:
- Age <18 yrs
- Pregnancy
- Moribund patients
- Risk of fluid loading induced pulmonary edema
- Cardiac arrhythmias
- Contraindication to perform PLR (intracranial hypertension, pelvic fractures)
Exclusion Criteria :
- Changes in vasopressor and sedation agents dosages during the protocol
- Changes in ventilatory parameters during the protocol
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acute Circulatory Failure
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Intervention(s)
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Other: Passive Leg Raising test
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Other: Fluid loading of 500 mL of crystalloid solution
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Primary Outcome(s)
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Increase in cardiac output in all mechanically ventilated patients
[Time Frame: Cardiac output will be measured immediately after the end of the volume expansion]
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Secondary Outcome(s)
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Increase in cardiac output in mechanically ventilated patients with spontaneous breathing activities
[Time Frame: Cardiac output will be measured immediately after the end of the volume expansion]
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Increase in cardiac output in mechanically ventilated patients with low tidal ventilation and/or low respiratory compliance
[Time Frame: Cardiac output will be measured immediately after the end of the volume expansion]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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