Respiratory Insufficiency Clinical Trial
Official title:
Does a Diagnostic Strategy Reduce Duration and Cost of Hospitalization in Patients With Acute Dyspnea? BASEL II Intensive Care Unit
Heart failure is a common reason for respiratory failure in ICU patients. The rapid and
accurate differentiation of heart failure from other causes of respiratory failure remains a
clinical challenge. BNP levels are significantly higher in patients with congestive heart
failure as compared to patients with respiratory failure due to other causes. Therefore,
rapid measurement of BNP might be very helpful in establishing or excluding the diagnosis of
heart failure in patients with respiratory failure in the ICU.
The aim is to test the hypothesis that a BNP guided diagnostic strategy would improve the
evaluation and management of patients presenting with primary (on admission) or secondary
(while in the ICU) respiratory failure in the ICU and thereby reduce total treatment time
and total cost of treatment.
Primary endpoints are time to discharge and total cost of treatment. Secondary endpoints are
ICU length of stay, ICU cost, in-hospital mortality, 30-day mortality, cost-effectiveness, 6
and 12 month mortality, 6 and 12 month dyspnea score.
Background: Respiratory failure is not only the most important reason for admission of
patients to a medical intensive care unit (ICU), but also a common reason for the
deterioration of patients already treated in the ICU. It is a very serious condition
associated with significant mortality. Heart failure is a common reason for respiratory
failure in both circumstances. Unfortunately, the rapid and accurate differentiation of
heart failure from other causes of respiratory failure in the ICU remains a clinical
challenge. After evaluation of symptoms, physical examination, arterial blood gases, ECG,
and chest x-ray, the clinician is often left with a considerable diagnostic uncertainty that
results in misdiagnosis and delay in the initiation of appropriate therapy. In addition,
misdiagnosis of heart failure causes morbidity, and increases total treatment time and
treatment cost, because treatments for heart failure may be hazardous to patients with other
conditions such as chronic obstructive pulmonary disease, and vice verse.
B-type natriuretic peptide (BNP) is a 32-amino acid polypeptide secreted from the cardiac
ventricles in response to ventricular volume expansion and pressure overload. BNP levels are
significantly higher in patients with congestive heart failure as compared to patients with
respiratory failure due to other causes. Therefore, rapid measurement of BNP might be very
helpful in establishing or excluding the diagnosis of heart failure in patients with
respiratory failure in the ICU.
Aim: The aim is to test the hypothesis that a BNP guided diagnostic strategy would improve
the evaluation and management of patients presenting with primary (on admission) or
secondary (while in the ICU) respiratory failure in the ICU and thereby reduce total
treatment time and total cost of treatment.
Endpoints: Primary endpoints: Time to discharge and total cost of treatment. Secondary
endpoints: ICU length of stay, ICU cost, In-hospital mortality, 30-day mortality,
cost-effectiveness, 6 and 12 month mortality, 6 and 12 month dyspnea score.
Patients and Methods: The trial is designed to enroll 286 patients presenting with primary
(on admission) or secondary (while in the ICU) respiratory failure in the ICU. Patients will
be randomly divided 1:1 into a clinical group using evaluation of patients according to
local standards without the use of BNP (or other natriuretic peptides) and to a BNP group
with early testing for BNP.
Expected results: The researchers hypothesize that a BNP guided diagnostic strategy will
improve the evaluation and management of patients presenting with respiratory failure to the
ICU and thereby reduce time to discharge and total cost of treatment.
Significance: If in fact, BNP testing could be shown to improve the evaluation and
management of patients with respiratory failure in the ICU, this would represent a major
advance in the clinical care of seriously ill patients, and as well, highlight the potential
for considerable cost-saving. Accordingly, if this study would have a positive result and in
fact demonstrate that a BNP guided diagnostic strategy reduces total treatment time and
total cost of treatment, it would be the first randomized controlled trial demonstrating
that a new diagnostic test improves the evaluation and management of ICU patients. Given the
enormous expenses associated with intensive care, such a study seems overdue.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
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