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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Mahatma Gandhi Institute of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Rajnish joshi, Mahatma Gandhi Institute of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01685385
First received: September 8, 2012
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Heart Failure
Congestive Cardiac Failure
Dyspnoea
Other: Patients who will receive the BNP test

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: B-type NAtriuretic Peptide In Critically Ill : A Multicentric Diagnostic Study (B-rAPID)

Resource links provided by NLM:


Further study details as provided by Mahatma Gandhi Institute of Medical Sciences:

Primary Outcome Measures:
  • In hospital mortality [ Time Frame: From admission to death in hospital and upto 30 days after admission to the hospital, whichever is earlier ] [ Designated as safety issue: No ]
    Assessment of In hospital mortality within 30-days of admission, and comparison between groups A and B.

  • 30-day mortality [ Time Frame: Upto 30 days from admission to hospital ] [ Designated as safety issue: No ]
    Mortality will be assessed after discharge from the hospital and upto 30 days from hospital admission and compared between groups A and B


Secondary Outcome Measures:
  • In-hospital morbidity [ Time Frame: Time of admission to ICU till death or discharge or 30days after admission, whichever is earlier ] [ Designated as safety issue: No ]
    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


Other Outcome Measures:
  • Intensity of In-hospital therapies administered [ Time Frame: First 24 hrs of ICU stay ] [ Designated as safety issue: No ]
    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.

  • Time to initiate heart failure specific therapies [ Time Frame: During hospital stay and upto 30-days after admission to hospital ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 800
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685385

Contacts
Contact: Dr.Rajnish Joshi, MD 919434026378 rjoshimgims@gmail.com
Contact: Dr,Vishakha Jain, MD 919545765581 vishakhajain@mgims.ac.in

Locations
India
Assam Medical College Not yet recruiting
Dibrugarh, Assam, India, 786002
Contact: Dr.BN Mahanta       bhupen_mahanta@yahoo.co.in   
Principal Investigator: Dr.BN Mahanta, MD         
Sub-Investigator: Dr.DJ Dutta, DM         
Sub-Investigator: Dr.Tulika Goswami, MD         
Mahatma Gandhi Institute of Medical Sciences Recruiting
Wardha, Maharashtra, India, 442102
Contact: Dr.Omprakash Gupta, MD    917152284341 ext 363    gupta_op@hotmail.com   
Contact: Dr.Vishakha Jain, MD    917152284341 ext 363    vishakhajain@mgims.ac.in   
Principal Investigator: Dr.Omprakash Gupta, MD         
Sub-Investigator: Dr.Samir Yelwatkar, MD         
Jawaharlal Nehru Medical college Recruiting
Wardha, Maharashtra, India, 44022
Contact: Dr.Bharti Taksande, MD    917152287701    bhartiganvir@mgims.ac.in   
Principal Investigator: Dr.Bharti Taksande, MD         
Sub-Investigator: Dr.SK Diwan, MD         
Sub-Investigator: Dr.Parimal Tayade, MD         
Sikkim Manipal Institute of Medical Sciences Recruiting
Gangtok, Sikkim, India, 737102
Contact: Dr.Bidita Khandelwal, MD    913592270535    drbidita@gmail.com   
Contact: Dr.Rajnish Joshi, MD    913592270535    rjoshimgims@gmail.com   
Principal Investigator: Dr.Bidita Khandelwal, MD         
Sub-Investigator: Dr.Dheeraj Khatri, MD         
Sub-Investigator: Dr.Nitin Shrivastav, MD         
Sponsors and Collaborators
Mahatma Gandhi Institute of Medical Sciences
Investigators
Principal Investigator: Dr.Rajnish Joshi, MD Sikkim Manipal Institute of Medical Sciences
Principal Investigator: Dr.Vishakha Jain, MD Mahatma Gandhi Institute of Medical Science
  More Information

No publications provided

Responsible Party: Rajnish joshi, Dr.Rajnish Joshi, Mahatma Gandhi Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT01685385     History of Changes
Other Study ID Numbers: MGIMS001/2012
Study First Received: September 8, 2012
Last Updated: October 10, 2012
Health Authority: India: Indian Council of Medical Research

Keywords provided by Mahatma Gandhi Institute of Medical Sciences:
Dyspnoea
BNP
Chronic heart failure
congestive heart failure

Additional relevant MeSH terms:
Critical Illness
Dyspnea
Heart Failure
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014