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Trial registered on ANZCTR


Registration number
ACTRN12616000143426
Ethics application status
Approved
Date submitted
16/10/2015
Date registered
5/02/2016
Date last updated
5/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
B –natriuritic peptide and troponin for diagnosis of cardiac origin weaning failure from mechanical ventilation: An observational study.
Scientific title
B –natriuritic peptide and troponin I as an alternative to echocardiography for diagnosis of cardiac origin weaning failure from mechanical ventilation : An observational study.
Secondary ID [1] 287670 0
nil
Universal Trial Number (UTN)
U1111-1175-5723
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
failure of weaning from mechanical ventilation 296504 0
Condition category
Condition code
Cardiovascular 296761 296761 0 0
Other cardiovascular diseases
Respiratory 297007 297007 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
Target follow-up type
Days
Description of intervention(s) / exposure
Patients were categorized into 3 groups according to spontaneous breathing trial outcome:
Group I: Heart failure group (heart failure as a cause of weaning failure).
Group II: Respiratory failure group (respiratory cause of weaning failure).
Group III: Success group.
Demographic data, causes of mechanical ventilation and severity score APACHE II (Acute Physiology And Chronic Health Evaluation) score; were recorded at admission to intensive care unit. Clinical, laboratory and echocardiographic data have been obtained immediately before and at the end of the spontaneous breathing trial.
Sample collection and biomarker assays: All arterial blood gases were measured using a blood gas analyzer. BNP and troponin I were measured in venous whole blood by staff blinded to clinical and echocardiographic findings.
Echocardiography
Transthoracic echocardiograms were performed in all patients immediately before and at the end of spontaneous breathing trial. Diastolic function was evaluated with pulse-wave doppler imaging and pulmonary flow measuring blood flow through the mitral valve. Systolic function was assessed in the apical four-chamber view. All echocardiography measurements were performed by cardiologist blinded to the natriuretic peptide, troponin I concentrations and SBT results. Heart failure will be diagnosed by the presence of echocardiography indices suggestive of filling pressures



Intervention code [1] 293061 0
Diagnosis / Prognosis
Intervention code [2] 293062 0
Early Detection / Screening
Comparator / control treatment
The success group is the control group Group III
Control group
Active

Outcomes
Primary outcome [1] 296373 0
Cardiac biomarkers: B-type natriuretic peptide (nano gram/liter), and troponin I (micro-gram/Liter) concentrations measured using serum assay.
Timepoint [1] 296373 0
measured before the start of the spontaneous breathing trial (baseline) and at the end of the trial
Primary outcome [2] 296374 0
Echocardiography indices (a composite primary outcome), including; The left ventricular ejection fraction (EF); the left ventricular end diastolic diameter (LVDTd) in millimeter, the ratio of early to late ventricular filling velocity (E/A ratio).
Timepoint [2] 296374 0
before the start of the spontaneous breathing trial (baseline) and at the end of the trial
Primary outcome [3] 296375 0
Respiratory parameters (a composite primary outcome) ; respiratory rate (breaths/minutes), tidal volume (Vt) (mL), respiratory rate/ tidal volume RR/Vt ratio (rapid shallow breathing index) using respiratory monitor.
Timepoint [3] 296375 0
before the beginning of the spontaneous breathing trial (baseline) and at the end of the trial
Secondary outcome [1] 318284 0
Arterial blood gases (ABGs) (a composite secondary outcome) including: PH, PaCO2 (mmHg), PaO2 (mmHg), SaO2.(%) by arterial blood samples.
Timepoint [1] 318284 0
before the beginning of the spontaneous breathing trial (baseline) and at the end of the trial
Secondary outcome [2] 318285 0
Haemodynamic parameters (a composite secondary outcome); Central venous pressure (CVP) in mmHg, Mean arterial pressure (MAP) in mmHg (using invasive measurement), and heart rate (HR) in beat per minute (using electrocardiogram,ECG), .
Timepoint [2] 318285 0
before the start of the spontaneous breathing trial (baseline) and at the end of the trial,
Secondary outcome [3] 318286 0
Cumulative fluid balance (using medical records).
Timepoint [3] 318286 0
was recorded from the time of ICU admission till the day of spontaneous breathing trial; (litre).
Secondary outcome [4] 318287 0
Duration of the spontaneous breathing trial (minutes) (using medical records)
Timepoint [4] 318287 0
Measured from time of starting of spontaneous breathing trial till its end (minutes).

Eligibility
Key inclusion criteria
The patients were selected from elderly patients aged more than 60 years old, who were under mechanical ventilation for more than 48 hours and fulfilling the criteria of weaning.
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient below the age of 60 years old, with renal failure, end stage chronic illness, preexisting neuromuscular disease, and patients without good transthoracic echocardiography window.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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] 7244 0
Egypt
State/province [1] 7244 0
Tanta, El Gharbia governorate

Funding & Sponsors
Funding source category [1] 292230 0
Self funded/Unfunded
Name [1] 292230 0
Hoda Alsaid Ahmed Ezz
Address [1] 292230 0
ElGeesh street, Department of Anesthesia and intensive Care, Tanta University Hospital ,Faculty of Medicine Tanta University,Tanta, El Gharbia Governorate ,Egypt.
postal code:31257
Country [1] 292230 0
Egypt
Primary sponsor type
Individual
Name
Hoda Alsaid Ahmed Ezz
Address
ElGeesh street, Department of Anesthesia and intensive Care, Tanta University Hospital ,Faculty of Medicine Tanta University,Tanta, El Gharbia Governorate ,Egypt.
postal code:31257
Country
Egypt
Secondary sponsor category [1] 290903 0
Individual
Name [1] 290903 0
Maha Mahmoud Hagras
Address [1] 290903 0
ElGeesh street, Department of Clinical Pathology, Tanta University Hospital ,Faculty of Medicine Tanta University,Tanta, El Gharbia Governorate ,Egypt.
postal code:31257
Country [1] 290903 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293697 0
ethics committee of the faculty of Medicine Tanta University
Ethics committee address [1] 293697 0
ElGeesh street, Department of Anesthesia and intensive Care, Tanta University Hospital ,Faculty of Medicine Tanta University,Tanta, El Gharbia Governorate ,Egypt.
postal code:31257
Ethics committee country [1] 293697 0
Egypt
Date submitted for ethics approval [1] 293697 0
13/10/2012
Approval date [1] 293697 0
15/02/2013
Ethics approval number [1] 293697 0

Summary
Brief summary
to evaluate B–natriuritic peptide and troponin I as an alternative to echocardiography for diagnosis of cardiac origin weaning failure from mechanical ventilation.
Trial website
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 53318 0
A/Prof Hoda Alsaid Ahmed Ezz
Address 53318 0
El Geesh street Tanta, Department of Anesthesia and surgical ICU,Faculty of Medicine Tanta University, Tanta ,El Gharbia govern orate, Egypt.
postal code:31257
Country 53318 0
Egypt
Phone 53318 0
+20 1222768250
Fax 53318 0
Email 53318 0
hodaezz714@yahoo.com
Contact person for public queries
Name 53319 0
Prof Abd El Raheem M. Dowidar
Address 53319 0
El Geesh street Tanta, Department of Anesthesia and surgical ICU,Faculty of Medicine Tanta University, Tanta ,El Gharbia govern orate, Egypt.
postal code:31257
Country 53319 0
Egypt
Phone 53319 0
+20 1223195015
Fax 53319 0
Email 53319 0
dr.dowidar47@hotmail.com
Contact person for scientific queries
Name 53320 0
Prof Abd El Raheem M. Dowidar
Address 53320 0
El Geesh street Tanta, Department of Anesthesia and surgical ICU,Faculty of Medicine Tanta University, Tanta ,El Gharbia govern orate, Egypt.
postal code:31257
Country 53320 0
Egypt
Phone 53320 0
+20 1223195015
Fax 53320 0
Email 53320 0
dr.dowidar47@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary