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. |
Register:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12616001431415 |
Date of registration:
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13/10/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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S wave variability to assess fluid responsiveness in critically ill patients: a pilot trial.
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Scientific title:
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S wave variability to assess fluid responsiveness in critically ill patients: a pilot trial. |
Date of first enrolment:
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01/01/2017 |
Target sample size:
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40 |
Recruitment status: |
Not yet recruiting |
URL:
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https://anzctr.org.au/ACTRN12616001431415.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Open (masking not used);
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Name:
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Dr Antonio Messina
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Address:
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AOU Maggiore della Carita'
Corso Mazzini 18
28100 Novara (NO)
Italy |
Telephone:
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+3903213733380 |
Email:
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mess81rc@gmail.com |
Affiliation:
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Name:
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Dr Antonio Messina
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Address:
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AOU Maggiore della Carita'
Corso Mazzini 18
28100 Novara (NO)
Italy |
Telephone:
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+3903213733380 |
Email:
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mess81rc@gmail.com |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Critically ill patients with an acute circulatory failure under conventional mechanical ventilation for whom the attending clinician had decided to administer fluid. This decision is based on the presence of at least one clinical sign of inadequate tissue perfusion in the absence of contraindication for fluid infusion.
Clinical signs of inadequate tissue perfusion are defined as
1) systolic blood pressure 90 mm Hg (or a decrease 50 mm Hg in previously hypertensive patients) or the need of vasopressive drugs (dopamine 5 mcg/kg/min or norepinephrine),
2) urine output 0.5 mL/kg/hr for at least 2 hrs,
3) tachycardia (heart rate HR 100/min)
4) presence of skin mottling
Exclusion criteria: 1) cardiac arrhythmias of any type.
2) moderate to severe ARDS
3) moderate to severe valvulopathies
4) inadequate acoustic window
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Anaesthesiology - Other anaesthesiology
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Hemodinamically unstable ICU patients requiring fluid administration;Hypotensive ICU patients;Critical Illness; Hemodinamically unstable ICU patients requiring fluid administration Hypotensive ICU patients Critical Illness
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Intervention(s)
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Tissue doppler performed before and at the end of fluid administration, to assess S wave variability Pulse pressure variation measured before and at the end of fluid administration Fluid administration consists in a single administration of 500 ml of intravenous crystalloids in 10 minutes.
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Primary Outcome(s)
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To compare the area under the curve (AUC) of the s wave variability and pulse pressure variation[The end of fluid challenge administration. Approximatively 1h after enrollment. There is a single time point, indicated by the end of the fluid challenge.]
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Secondary Outcome(s)
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To assess the reproducibility of tissue doppler evaluation between operators[Post-hoc analysis. End of enrollment.]
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To assess the sensitivity of s wave variability in comparison to pulse pressure variation[The end of fluid challenge administration. Approximatively 1h after enrollment.
Single Timepoint]
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To assess specificity of s wave variability in comparison to pulse pressure variation[The end of fluid challenge administration. Approximatively 1h after enrollment.
Single Timepoint]
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Secondary ID(s)
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DELTA_S wave
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Source(s) of Monetary Support
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AOU Maggiore della Carita'
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Ethics review
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Status: Approved
Approval date:
Contact:
Comitato etico interaziendale AOU Maggiore della Carita'
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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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