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Completed

NCT Number: NCT03871166

Hemoglobin Concentration in Patients With an Acute Respiratory Distress Syndrome

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.

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Key information

Conditions

ARDS, Human Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Operative Intensive Care Medicine Campus Virchow-Klinikum

Berlin, 13353, Germany

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood transfusion

Other

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]

Primary outcomes

  1. Mortality

    Time frame: 01/2007 - 12/2018

    Mortality of patients with ARDS at 28 days according to transfusion threshold

Secondary outcomes

  1. Failure-free days composites

    Time frame: 01/2007 - 12/2018

    Failure-free days composites according to transfusion threshold

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 12, 2019
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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