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Trial registered on ANZCTR


Registration number
ACTRN12617000076370
Ethics application status
Approved
Date submitted
10/11/2016
Date registered
13/01/2017
Date last updated
19/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation of a novel algorithm for dynamic assessment of fluid challenge: a multicentric study
Scientific title
Validation of a novel algorithm for dynamic assessment of fluid challenge: a multicentric study
Secondary ID [1] 290358 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypotension 300647 0
Hypoperfusion 300648 0
Acute circulatory failure 300649 0
Condition category
Condition code
Anaesthesiology 300493 300493 0 0
Other anaesthesiology
Cardiovascular 300494 300494 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fluid challenge consisting in 500 ml of intravenous crystalloids (both saline 0,9% or Ringer Acetate or Lactate were allowed), administered in 10 minutes.
The Fluid challenge is administered by the attending physician to correct hemodynamic instability.
All the patients received hemodynamic monitoring with the MostCare system which provides all the hemodynamic variables evaluated in the study before and after fluid challenge administration (cardiac output, stroke volume, arterial elastance (Ea), cardiac cycle efficiency (CCE)).
In a previous pilot study a model including baseline pulse pressure variation, the variation of systolic arterial pressure - dicrotic pressure and CCE showed the greater AUC (0.92), and correctly identified the efficacy of FC in 87% of patients (84.2% of responders and 92.5 of non-responders). The following formula describes this latter model:
0.039+1.042*(DELTASAP- Pdic 5min)+1.278* DELTACCE5min+1.159*PPVbaseline
Intervention code [1] 296172 0
Treatment: Other
Comparator / control treatment
The pulse pressure variation, a dynamic index of fluid responsiveness, has been considered as the gold standard. Off line evaluation of PPV before and after the fluid challenge was the used as control treatment
Control group
Active

Outcomes
Primary outcome [1] 300145 0
To consider the fluid responsiveness (i.e increase in cardiac index after fluid challenge administration) of the patient by means of model application. Fluid responsiveness is assessed by means of Mostcare system and is defined as the increase of at least 15% of the cardiac index after the infusion of a fluid challenge of 500 ml of crystalloids in 10 minutes.
Timepoint [1] 300145 0
Minutes 1 2 3 4 5 after fluid challenge infusion
Secondary outcome [1] 329189 0
To compare the area under the curve (AUC) of the model with the AUC of baseline pulse pressure variation.
The ROC curve is calculated considering the variations of the hemodynamic parameters assessed by means of Mostcare system and the response to fluid administration.
Timepoint [1] 329189 0
Minutes 1 2 3 4 5 after fluid challenge infusion
Secondary outcome [2] 343342 0
Updating timing of hemodynamic assessment.
Timepoint [2] 343342 0
10 - 15 and 30 minutes after fluid challenge infusion

Eligibility
Key inclusion criteria
Group 1 (ICU septic) and 2 (ICU non septic): Acute circulatory failure defined by a systolic arterial pressure less than or equal to 90 mm Hg (or fall of systolic arterial pressure higher or equal to 50 mm Hg in known hypertensive patients) and one or more of the following signs: 1) urinary flow less than or equal to 0.5 mL/kg/min for greater than or equal to 2 hours, 2) tachycardia greater than or equal to 100 bpm, or 3) presence of skin mottling.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For ICU group the exclusion criteria are: 1) New York Heart Association (NYHA) class III or IV, or severe valvular diseases, or right ventricle systolic dysfunction; 2) cardiac arrhythmias; 3) severe ARDS (4); 4) haemodialysis or continuous hemofiltration; 5) any condition affecting arterial waveform including acute/chronic aortic dissection, thoracic outlet syndrome, subclavian artery stenosis and uncorrected under- or over-damping of the pressure thransducer.

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
Single group
Other design features
The study will enrolled 2 groups of patients: Group 1, ICU septic patients; Group 2, ICU non septic patients
Phase
Type of endpoint(s)
Statistical methods / analysis
The sample size is calculated by means of non-inferiority ROC comparison approach.
Considering the AUC of pulse pressure variation at baseline for ICU patients ventilated with less than 8 ml/kg as high as 0.70, according to the literature, and expecting and AUC of at least 0.80 for the model including the considered hemodynamic variables (82 patients)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8334 0
Italy
State/province [1] 8334 0
Piedmont
Country [2] 8335 0
Spain
State/province [2] 8335 0
Spain
Country [3] 8336 0
France
State/province [3] 8336 0
France

Funding & Sponsors
Funding source category [1] 294742 0
Self funded/Unfunded
Name [1] 294742 0
Antonio Messina
Address [1] 294742 0
Corso Mazzini, 18 28100 Novara
Country [1] 294742 0
Italy
Primary sponsor type
Individual
Name
antonio messina
Address
AOU Maggiore della Carita'
Corso Mazzini, 18
28100 Novara (NO)
Intensive care unit
Country
Italy
Secondary sponsor category [1] 293591 0
Individual
Name [1] 293591 0
Stefano Romagnoli
Address [1] 293591 0
AOU Careggi
Largo G. Alessandro Brambilla, 3, 50134
Firenze
Italy
Country [1] 293591 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296159 0
Comitato etico Interaziendale AOU Maggiore della Carita'
Ethics committee address [1] 296159 0
Corso Mazzini, 18
28100 Novara (NO)
Ethics committee country [1] 296159 0
Italy
Date submitted for ethics approval [1] 296159 0
10/11/2016
Approval date [1] 296159 0
19/12/2016
Ethics approval number [1] 296159 0

Summary
Brief summary
This is a multi centric study aiming to test the reliability of a novel algorithm including the analysis of baseline pulse pressure variation (PPV), cardicac cycle efficiecy (CCE) and the difference between systolic pressure and dicrotic pressure (SAP-Pdic). In a previous pilot trial we found that this dynamic approach could predict the outcome of a fluid challenge better than purely baseline assessment of PPV. This could spare inappropriate fluid administration in those patient who should not receive fluid despite hemodynamic instability. To test our hypothesis will be studied 2 groups of patients in ICU (septic and non septic patients). All the patients will receive fluid as part of standard care and all the hemodynamic variables will be recorded by means of MostCare system. The reliability of the model will be evaluated post hoc (after fluid administration), and compared to the PPV value before fluid administration.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1189 1189 0 0
http://www.anzctr.org.au/AnzctrAttachments/371685-Algoritmo.docx (Supplementary information)

Contacts
Principal investigator
Name 69798 0
Dr antonio messina
Address 69798 0
AOU Maggiore della Carita'
Corso Mazzini, 18
28100 Novara (NO)
Country 69798 0
Italy
Phone 69798 0
+393498666281
Fax 69798 0
+393498666281
Email 69798 0
mess81rc@gmail.com
Contact person for public queries
Name 69799 0
Dr antonio messina
Address 69799 0
AOU Maggiore della Carita'
Corso Mazzini, 18
28100 Novara (NO)
Country 69799 0
Italy
Phone 69799 0
+393498666281
Fax 69799 0
+393498666281
Email 69799 0
mess81rc@gmail.com
Contact person for scientific queries
Name 69800 0
Dr antonio messina
Address 69800 0
AOU Maggiore della Carita'
Corso Mazzini, 18
28100 Novara (NO)
Country 69800 0
Italy
Phone 69800 0
+393498666281
Fax 69800 0
+393498666281
Email 69800 0
mess81rc@gmail.com

No information has been provided regarding IPD availability
Summary results
No Results