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NCT03871166 Clinical Trial

Hemoglobin Concentration in Patients With an Acute Respiratory Distress Syndrome

ARDS, Human Clinical Trial

Official title:
Hemoglobin Concentration in Patients With an Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03871166
Other study ID # RECETTA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date November 24, 2020

Study information
Verified date January 2021
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Retrospective analysis of hemoglobin concentrations and red cell transfusion thresholds in patients with an Acute Respiratory Distress Syndrome (ARDS) admitted to an ARDS-center of a German university hospital.

Description:

Transfusion of packed red blood cells is a common procedure in critically ill patients. In recent years it has been shown that for many patient populations a restrictive transfusion strategy is not inferior compared to a liberal transfusion strategy with regard to overall outcome. So far it is unclear whether patients with an ARDS should receive blood transfusions according to a restrictive or liberal transfusion strategy. Besides pulmonary gar exchange and cardiac output, the hemoglobin concentration is an important determinant for oxygen delivery. The aim of this retrospective observational study is to analyze if low levels of hemoglobin/a restrictive transfusion strategy and are associated with a different mortality compared to higher levels of hemoglobin/a liberal transfusion strategy in patients with an ARDS.

Recruitment information / eligibility
Status Completed
Enrollment 1044
Est. completion date November 24, 2020
Est. primary completion date July 1, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All adult patients with ARDS - Admission to the Charité ARDS center Exclusion Criteria: - All patients <18 years at the time of admission - All patients with ARDS not admitted to the Charité ARDS center

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Blood transfusion
Observational post-ad-hoc design to compare patients admitted with an ARDS and separated into different groups according to their mean hemoglobin concentration during their stay on the intensive care unit. Approximately 1000 adult patients admitted from 2007 to 2018 to the Charite ARDS center will be enrolled in the study. They are followed up until their discharge from the ICU. [Time Frame: 01/2007 - 12/2018]

Locations
Country Name City State
Germany Department of Anesthesiology and Operative Intensive Care Medicine Campus Virchow-Klinikum Berlin

Sponsors (1)
Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality Mortality of patients with ARDS at 28 days according to transfusion threshold 01/2007 - 12/2018
Secondary Failure-free days composites Failure-free days composites according to transfusion threshold 01/2007 - 12/2018
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