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

Respiratory Insufficiency Clinical Trial

Official title:

Does a Diagnostic Strategy Reduce Duration and Cost of Hospitalization in Patients With Acute Dyspnea? BASEL II Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130559
• Other study ID #: BASEL II - ICU
• Secondary ID: PP00B-102853/104
• Status: Completed
• Phase: Phase 4
• First received: August 12, 2005
• Last updated: October 18, 2011
• Start date: December 2003
• Est. completion date: March 2008

Study information

• Verified date: October 2011
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: March 2008
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Procedure:
• BNP guided diagnostics and initial therapy
BNP guided diagnostics and initial therapy

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Medical ICU	Basel	Basel-Stadt
Switzerland	University Hospital Basel, Surgical ICU	Basel	Basel-Stadt
Switzerland	Hospital of Interlaken	Interlaken	Bern
Switzerland	Hospital of Luzern	Luzern
Switzerland	Hospital of Solothurn	Solothurn
Switzerland	Hospital of Thun	Thun	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Mueller C, Scholer A, Laule-Kilian K, Martina B, Schindler C, Buser P, Pfisterer M, Perruchoud AP. Use of B-type natriuretic peptide in the evaluation and management of acute dyspnea. N Engl J Med. 2004 Feb 12;350(7):647-54. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to discharge		discharge	No
Primary	Total cost of treatment		until discharge	No
Secondary	ICU length of stay		discharge from ICU	No
Secondary	ICU cost		until discharge from ICu	No
Secondary	In-hospital mortality		discharge	No
Secondary	30-day mortality		30 days	No
Secondary	cost-effectiveness		discharge	No
Secondary	6 and 12 month mortality		12 months	No
Secondary	6 and 12 month dyspnea score		12 months	No
Secondary	Incidence/recognition of congestive heart failure (CHF) as a major cause of respiratory failure		discharge from ICU+	No
Secondary	Incidence of diagnosed CHF as cause of respiratory failure in patients with COPD on ICU		discharge	No
Secondary	Number of echo study performing during hospital stay		hospital discharge	No

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