B-type NAtriuretic Peptide In Critically Ill : A Multicentric Diagnostic Study (B-rAPID) (B-RAPID)

October 10, 2012 updated by: Rajnish joshi, Mahatma Gandhi Institute of Medical Sciences
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • India
    • Assam
      • Dibrugarh, Assam, India, 786002
        • Not yet recruiting
        • Assam Medical College
        • Contact:
        • Principal Investigator:
          • Dr.BN Mahanta, MD
        • Sub-Investigator:
          • Dr.DJ Dutta, DM
        • Sub-Investigator:
          • Dr.Tulika Goswami, MD
    • Maharashtra
      • Wardha, Maharashtra, India, 44022
        • Recruiting
        • Jawaharlal Nehru Medical College
        • Contact:
        • Principal Investigator:
          • Dr.Bharti Taksande, MD
        • Sub-Investigator:
          • Dr.SK Diwan, MD
        • Sub-Investigator:
          • Dr.Parimal Tayade, MD
      • Wardha, Maharashtra, India, 442102
        • Recruiting
        • Mahatma Gandhi Institute of Medical Sciences
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dr.Omprakash Gupta, MD
        • Sub-Investigator:
          • Dr.Samir Yelwatkar, MD
    • Sikkim
      • Gangtok, Sikkim, India, 737102
        • Recruiting
        • Sikkim Manipal Institute of Medical Sciences
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dr.Bidita Khandelwal, MD
        • Sub-Investigator:
          • Dr.Dheeraj Khatri, MD
        • Sub-Investigator:
          • Dr.Nitin Shrivastav, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Diagnostic intervention group A
Patients who will receive the BNP test
Other: Patients who will receive the BNP test
Patients in Diagnostic Intervention Group A will receive the point-of-care BNP test, in addition to all other diagnostics they receive in addition
NO_INTERVENTION: Group B
Patients who will not receive the BNP test.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
In hospital mortality
Time Frame: From admission to death in hospital and upto 30 days after admission to the hospital, whichever is earlier
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
30-day mortality
Time Frame: Upto 30 days from admission to hospital
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
In-hospital morbidity
Time Frame: Time of admission to ICU till death or discharge or 30days after admission, whichever is earlier
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intensity of In-hospital therapies administered
Time Frame: First 24 hrs of ICU stay
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
Time to initiate heart failure specific therapies
Time Frame: During hospital stay and upto 30-days after admission to hospital
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mahatma Gandhi Institute of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr.Rajnish Joshi, MD, Sikkim Manipal Institute of Medical Sciences
  • Principal Investigator: Dr.Vishakha Jain, MD, Mahatma Gandhi Institute of Medical Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MGIMS001/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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