Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130559
Status:
COMPLETED
Last Update Posted:
2011-10-19
First Post:
2005-08-12
Brief Title:
B-type Natriuretic Peptide BNP-Guided Diagnostic Strategy in Intensive Care Unit ICU Patients With Respiratory Failure
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Does a Diagnostic Strategy Reduce Duration and Cost of Hospitalization in Patients With Acute Dyspnea BASEL II Intensive Care Unit
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 11 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
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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3601 | None | None | None |
| PP00B-1028531 | None | None | None |
| 04061 | None | None | None |