Heart Failure Clinical Trial
— B-RAPIDOfficial 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.
Status | Recruiting |
Enrollment | 800 |
Est. completion date | December 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: We will include all consecutive patients admitted to intensive care units in participating sites with all of the following features: - Adult aged 18 years or more - Acute onset dyspnea (duration 3 days or less) , defined as respiratory rate of 20 or more. - Treating physician considers patient to be critically ill so as to warrant care in intensive care unit. Exclusion Criteria: Patients for whom consent is not obtained will be excluded from the study |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
India | Assam Medical College | Dibrugarh | Assam |
India | Sikkim Manipal Institute of Medical Sciences | Gangtok | Sikkim |
India | Jawaharlal Nehru Medical college | Wardha | Maharashtra |
India | Mahatma Gandhi Institute of Medical Sciences | Wardha | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Mahatma Gandhi Institute of Medical Sciences |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Intensity of In-hospital therapies administered | To compare the difference in cumulative dose of diuretics, parenteral antibiotics, corticosteroids, and bronchodilators administered within first 24 hours of admission to ICU, between groups A and B. | First 24 hrs of ICU stay | No |
Other | Time to initiate heart failure specific therapies | To Compare the difference in time to initiate heart failure specific therapies (diuretics, angiotensin converting enzyme inhibitors, beta-blockers, and spironolactone) in groups A and B, during hospital stay and upto 30-days of admission to hospital. | During hospital stay and upto 30-days after admission to hospital | No |
Primary | In hospital mortality | Assessment of In hospital mortality within 30-days of admission, and comparison between groups A and B. | From admission to death in hospital and upto 30 days after admission to the hospital, whichever is earlier | No |
Primary | 30-day mortality | Mortality will be assessed after discharge from the hospital and upto 30 days from hospital admission and compared between groups A and B | Upto 30 days from admission to hospital | No |
Secondary | In-hospital morbidity | In-hospital morbidity, measured as a) duration of ICU stay, duration of hospital stay, need for mechanical ventilation or renal replacement during hospitalization, measured upto 30-days after admission to hospital | Time of admission to ICU till death or discharge or 30days after admission, whichever is earlier | No |
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