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

NCT01685385 | Unknown

• 1 other identifier: MGIMS001/2012
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Heart Failure; Congestive Cardiac Failure; Dyspnoea

Keywords

Dyspnoea; BNP; Chronic heart failure; congestive heart failure

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• In-hospital morbidity

  Time of admission to ICU till death or discharge or 30days after admission, whichever is earlier

Other Outcomes (2)

• Intensity of In-hospital therapies administered

  First 24 hrs of ICU stay

• Time to initiate heart failure specific therapies

  During hospital stay and upto 30-days after admission to hospital

Study Arms (2)

Diagnostic intervention group A

ACTIVE COMPARATOR

Patients who will receive the BNP test

Other: Patients who will receive the BNP test

Group B

NO INTERVENTION

Patients who will not receive the BNP test.

Interventions

Patients who will receive the BNP test OTHER

Patients in Diagnostic Intervention Group A will receive the point-of-care BNP test, in addition to all other diagnostics they receive in addition

Diagnostic intervention group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients for whom consent is not obtained will be excluded from the study

Sponsors & Collaborators

• Mahatma Gandhi Institute of Medical Sciences: lead

Study Sites (4)

Assam Medical College

Dibrugarh, Assam, 786002, India

NOT YET RECRUITING

Jawaharlal Nehru Medical college

Wardha, Maharashtra, 44022, India

RECRUITING

Mahatma Gandhi Institute of Medical Sciences

Wardha, Maharashtra, 442102, India

RECRUITING

Sikkim Manipal Institute of Medical Sciences

Gangtok, Sikkim, 737102, India

RECRUITING

MeSH Terms

Conditions

Heart Failure; Dyspnea

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr.Rajnish Joshi, MD

  Sikkim Manipal Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Dr.Vishakha Jain, MD

  Mahatma Gandhi Institute of Medical Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr.Rajnish Joshi, MD

CONTACT

919434026378; rjoshimgims@gmail.com

Dr,Vishakha Jain, MD

CONTACT

919545765581; vishakhajain@mgims.ac.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Rajnish Joshi

Study Record Dates

• First Submitted: September 8, 2012
• First Posted: September 14, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 12, 2012

Record last verified: 2012-10

Locations

IN (4)