B-type Natriuretic Peptide (BNP)-Guided Diagnostic Strategy in Intensive Care Unit (ICU) Patients With Respiratory Failure

This study has been completed.
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00130559
First received: August 12, 2005
Last updated: October 18, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Respiratory Insufficiency
Procedure: BNP guided diagnostics and initial therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Does a Diagnostic Strategy Reduce Duration and Cost of Hospitalization in Patients With Acute Dyspnea? BASEL II Intensive Care Unit

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Time to discharge [ Time Frame: discharge ] [ Designated as safety issue: No ]
  • Total cost of treatment [ Time Frame: until discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ICU length of stay [ Time Frame: discharge from ICU ] [ Designated as safety issue: No ]
  • ICU cost [ Time Frame: until discharge from ICu ] [ Designated as safety issue: No ]
  • In-hospital mortality [ Time Frame: discharge ] [ Designated as safety issue: No ]
  • 30-day mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • cost-effectiveness [ Time Frame: discharge ] [ Designated as safety issue: No ]
  • 6 and 12 month mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 6 and 12 month dyspnea score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence/recognition of congestive heart failure (CHF) as a major cause of respiratory failure [ Time Frame: discharge from ICU+ ] [ Designated as safety issue: No ]
  • Incidence of diagnosed CHF as cause of respiratory failure in patients with COPD on ICU [ Time Frame: discharge ] [ Designated as safety issue: No ]
  • Number of echo study performing during hospital stay [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]

Enrollment: 286
Study Start Date: December 2003
Study Completion Date: March 2008
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: BNP guided diagnostics and initial therapy
    BNP guided diagnostics and initial therapy
Detailed Description:

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.

  Eligibility

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

Inclusion Criteria:

  • Patients presenting with primary or secondary respiratory failure in the ICU

Exclusion Criteria:

  • Age <18 years
  • Obvious traumatic cause
  • Renal dysfunction (serum creatinine >250umol/l)
  • Sepsis
  • Cardiopulmonary reanimation within the last 12 hours
  • Shock
  • Respiratory insufficiency triggered during bronchoscopy
  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: NCT00130559

Locations
Switzerland
University Hospital Basel, Medical ICU
Basel, Basel-Stadt, Switzerland, 4031
University Hospital Basel, Surgical ICU
Basel, Basel-Stadt, Switzerland, 4031
Hospital of Interlaken
Interlaken, Bern, Switzerland, 3800
Hospital of Thun
Thun, Bern, Switzerland, 3600
Hospital of Luzern
Luzern, Switzerland, 6000
Hospital of Solothurn
Solothurn, Switzerland, 4500
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Investigators
Principal Investigator: Christian Mueller, Prof University Hospital, Basel, Switzerland
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00130559     History of Changes
Other Study ID Numbers: BASEL II - ICU, PP00B-102853/1, 04.061, 36/01
Study First Received: August 12, 2005
Last Updated: October 18, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
Respiratory failure
BNP

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 30, 2014