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临床试验/NCT00130559
NCT00130559已完成4 期

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

University Hospital, Basel, Switzerland12 个研究点 分布在 1 个国家目标入组 286 人开始时间: 2003年12月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
286
试验地点
12
主要终点
Time to discharge

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Time to discharge

时间窗: discharge

Total cost of treatment

时间窗: until discharge

次要结局

  • ICU length of stay(discharge from ICU)
  • ICU cost(until discharge from ICu)
  • In-hospital mortality(discharge)
  • 30-day mortality(30 days)
  • cost-effectiveness(discharge)
  • 6 and 12 month mortality(12 months)
  • 6 and 12 month dyspnea score(12 months)
  • Incidence/recognition of congestive heart failure (CHF) as a major cause of respiratory failure(discharge from ICU+)
  • Incidence of diagnosed CHF as cause of respiratory failure in patients with COPD on ICU(discharge)
  • Number of echo study performing during hospital stay(hospital discharge)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (12)

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