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Trial registered on ANZCTR


Registration number
ACTRN12616001431415
Ethics application status
Approved
Date submitted
16/09/2016
Date registered
13/10/2016
Date last updated
13/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
S wave variability to assess fluid responsiveness in critically ill patients: a pilot trial.
Scientific title
S wave variability to assess fluid responsiveness in critically ill patients: a pilot trial.
Secondary ID [1] 290164 0
DELTA_S wave
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemodinamically unstable ICU patients requiring fluid administration 300289 0
Hypotensive ICU patients 300292 0
Critical Illness 300349 0
Condition category
Condition code
Anaesthesiology 300157 300157 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 295919 0
Diagnosis / Prognosis
Comparator / control treatment
Pulse Pressure Variation (PPV) is the gold standard used to compare S variability.
PPV is provided by the hemodynamic monitoring connected to the patient before enrollment.
Hemodynamic monitoring is required by the clinical condition of the patient and is not related to the study enrollment.
Control group
Active

Outcomes
Primary outcome [1] 299651 0
To compare the area under the curve (AUC) of the s wave variability and pulse pressure variation
Timepoint [1] 299651 0
The end of fluid challenge administration. Approximatively 1h after enrollment.
There is a single time point, indicated by the end of the fluid challenge.
Secondary outcome [1] 327751 0
To assess the sensitivity of s wave variability in comparison to pulse pressure variation
Timepoint [1] 327751 0
The end of fluid challenge administration. Approximatively 1h after enrollment.
Single Timepoint
Secondary outcome [2] 328248 0
To assess specificity of s wave variability in comparison to pulse pressure variation
Timepoint [2] 328248 0
The end of fluid challenge administration. Approximatively 1h after enrollment.
Single Timepoint
Secondary outcome [3] 328249 0
To assess the reproducibility of tissue doppler evaluation between operators
Timepoint [3] 328249 0
Post-hoc analysis. End of enrollment.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) cardiac arrhythmias of any type.
2) moderate to severe ARDS
3) moderate to severe valvulopathies
4) inadequate acoustic window

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Data distribution was evaluated by means of the Kolmogorov-Smirnov test. Continuous variable are presented as mean +/- standard deviation, while categorical as percentage (95% confidence interval [CI]). The paired or unpaired Student’s t-test are used for head-to-head comparisons of parametric data, as indicated, while discrete variables were analyzed using the Chi-squared.
The discriminative power of pulse pressure variation (PPV) and variability of S wave (DELTA_S) is assessed using receiver operating characteristic (ROC) curves (95%, CI).
Comparison of two area under the ROC curves is performed using the nonparametric
technique described by DeLong et al.
For all tests, the null hypothesis was rejected for p values <0.05.
Sample size not calculated because of the absence of clinical trials evaluating the same parameters of the present studies. The sample size of 40 patients has beed decided basing on previous results of similar studies in critically ill patients.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 8232 0
Italy
State/province [1] 8232 0
NOVARA, SIENA, FLORENCE

Funding & Sponsors
Funding source category [1] 294531 0
Hospital
Name [1] 294531 0
AOU Maggiore della Carita'
Country [1] 294531 0
Italy
Primary sponsor type
Individual
Name
Antonio Messina, MD, PhD
Address
AOU Maggiore della Carita'
Corso Mazzini 18,
28100 Novara (NO) - Italy
Department of Emergency - Intensive Care unit
Country
Italy
Secondary sponsor category [1] 293396 0
None
Name [1] 293396 0
No sponsorship
Address [1] 293396 0
No sponsorship
Country [1] 293396 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295966 0
Comitato etico interaziendale AOU Maggiore della Carita'
Ethics committee address [1] 295966 0
Corso Mazzini,18 - 28100 Novara (NO)
Italy
Ethics committee country [1] 295966 0
Italy
Date submitted for ethics approval [1] 295966 0
20/07/2016
Approval date [1] 295966 0
09/09/2016
Ethics approval number [1] 295966 0
prot 796/CE; study number 122/16

Summary
Brief summary
This prospective pilot trial aims to investigate the reliability of a non invasive hemodynamic parameter obtained by means of tissue doppler in critically ill patients.
In particular, the s wave is related to the systolic function of both right and left ventricles.
The purpose of the study is to investigate the sensitivity and specificity of s wave variability, compared to the gold standard of pulse pressure variation (PPV) - a non invasive parameter measured by many different hemodynamic monitors- in assessing the fluid responsiveness.
Fluid responsiveness is defined as the ability of increasing the cardiac index after a infusion of a standard amount of fluids (500 ml of crystalloids in 30 minutes, fluid challenge).
The study protocol consists in 4 steps:
1) enrollment of patients who need fluid resuscitation (see inclusion criteria) and already monitored with a tool measuring PPV
2) echocardiographic evaluation of s waves (both right and left)
3) fluid challenge administration
4) data analysis
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63778 0
Dr Antonio Messina
Address 63778 0
AOU Maggiore della Carita'
Corso Mazzini 18
28100 Novara (NO)
Country 63778 0
Italy
Phone 63778 0
+3903213733380
Fax 63778 0
Email 63778 0
[email protected]
Contact person for public queries
Name 63779 0
Dr Antonio Messina
Address 63779 0
AOU Maggiore della Carita'
Corso Mazzini 18
28100 Novara (NO)
Country 63779 0
Italy
Phone 63779 0
+3903213733380
Fax 63779 0
Email 63779 0
[email protected]
Contact person for scientific queries
Name 63780 0
Dr Antonio Messina
Address 63780 0
AOU Maggiore della Carita'
Corso Mazzini 18
28100 Novara (NO)
Country 63780 0
Italy
Phone 63780 0
+3903213733380
Fax 63780 0
Email 63780 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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