Heart Failure Clinical Trial
Official title:
B-type NAtriuretic Peptide In Critically Ill : A Multicentric Diagnostic Study (B-rAPID)
Difficulty in breathing or increased rate of breathing are common causes of admission to intensive care unit. This may be due to heart failure, or other causes such as infection in the lungs. Treating doctors usually perform Chest X-ray, ECG, and other tests to know if breathlessness is due to heart failure or other cause. Doctors also give medicines to treat heart failure, or other conditions of the lungs based on the symptoms and investigation results. BNP is released by heart which is not functioning well. However BNP levels are also high in case of severe infection.Hence there is equipoise in utility of BNP measurements among critically ill patients, and it is not a current standard of care. The current cost of this test (about 1000 rupees per measurement) is high, and hence its utility needs to be carefully examined before a widespread use. The investigators intend to test the hypothesize that that on-admission BNP measurements, help clinicians identify CHF early, which may modify therapeutic decisions, and improve outcomes. The current study is designed with an objective to determine if on-admission BNP value and availability of its test results to treating physicians will reduce in-hospital, and 30-day mortality and in-hospital morbidity.
There usually remains a diagnostic uncertainty as differentiation between cardiogenic or
non-cardiogenic cause of dyspnea. Often there are multiple underlying etiologies for acute
onset dyspnea, and their evaluation leads to diagnostic delays, and hence longer hospital
stay. While various clinical symptoms, signs and imaging based investigations are used in
this differentiation, their accuracy remains low, and overlapping features preclude such
differentiation. Echocardiography is an important adjunct in making such differentiation,
but operator skill, and lack of availability of this technique at point of care are barriers
in use of this modality. B-type natriuretic peptide (BNP), a rapidly-assayed, serum
biomarker, has been found to be effective in distinguishing congestive heart failure (CHF)
from other causes of dyspnea in the emergency or urgent care settings. Recently this test
has become available at point of care (Alere Heart-Check). Ease, low cost, and objectivity
in measurement of BNP has led to widespread incorporation of BNP and its precursor
NT-pro-BNP into the clinical evaluation of CHF.
Circulating levels of BNP/NT-proBNP are normally very low in healthy individuals. In
response to increased myocardial wall stress due to volume- or pressure-overload states
(such as in CHF), the BNP gene is activated in cardiomyocytes. This results in the
production of an intracellular precursor propeptide (proBNP108); further processing of this
propeptide results in release of the biologically inert aminoterminal fragment (NT-proBNP)
and the biologically active BNP.Various studies have been performed to determine cut-off
level to make a differentiation between presence or absence of CHF using this test. BNP
level below 50pg/ml rules out CHF with a negative predictive value of 96%. (3) In the same
study by Maisel et al the diagnostic accuracy of B-type natriuretic peptide to rule in CHF
at a cutoff of 100 pg per milliliter or more was 83.4 percent. However subsequent studies
have instead suggested a multiple cut-point strategy (Less than 100pg/ml rules out CHF (NPV
90%), more than 400 pg/ml rules in CHF (91% specificity) while intermediate values
representing a grey zone. Individuals with renal dysfunction have elevated BNP levels, and a
lower cut-off to exclude CHF in such patients is 200pg/ml. Individuals with a high BMI have
falsely low levels and a BMI adjusted correction is used (Lower cut-off of 54pg/mL if BMI
>35kg/m2). The levels of BNP as well as NT-Pro-BNP have similar elevations in CHF, later
being three times as much higher. (1) Use of BNP to differentiate CHF from other causes of
dyspnea, (4) and ease in its measurement has resulted in increase in its use in intensive
care settings, as point-of-care testing has a potential to change outcomes. However when the
test is used in this setting, very high BNP levels were detected in critically ill patients
with sepsis and shock. In patients with shock, levels below 1200pg/ml had a negative
predictive value of 92% for cardiogenic shock. Such high levels in patients with compromised
systolic function have questioned utility of this measure to distinguish between CHF and
other causes in critical care settings. It is debated that in critically ill patients,
coexisting other organ dysfunction, rapid changes in volume status, variable bioavailability
and burst synthesis of BNP may all confound interpretation of BNP levels. However despite
this confounding, even in critically ill patients higher values are associated with adverse
prognosis, and very low levels (less than 100pg/ml) will mean a preserved left ventricular
function. Thus, while it is known that BNP really gives useful information, not already
available from other clinical, radiologic and biochemical measurements, what the
investigators do not know is if the test results become available in an intensive care unit
setting, will it help treating physicians to make meaningful clinical decisions.
Given above considerations, there is equipoise in utility of BNP measurements among
critically ill patients, and it is not a current standard of care. The current cost of this
test (about 1000 rupees per measurement) is high, and hence its utility needs to be
carefully examined before a widespread use. The investigators intend to test the hypothesize
that that on-admission BNP measurements, help clinicians identify CHF early, which may
modify therapeutic decisions, and improve outcomes. The current study is designed with an
objective to determine if on-admission BNP value and availability of its test results to
treating physicians will reduce in-hospital, and 30-day mortality and in-hospital morbidity.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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