Hemoglobin Concentration in Patients With an Acute Respiratory Distress Syndrome

NCT ID: NCT03871166

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1044 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-11-24

Brief Summary

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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.

Detailed Description

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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.

Conditions

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ARDS, Human

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

\[Time Frame: 01/2007 - 12/2018\]

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Jan Adriaan Graw

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan A Graw, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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

Berlin, , Germany

Site Status

Countries

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Germany

References

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Hunsicker O, Materne L, Bunger V, Krannich A, Balzer F, Spies C, Francis RC, Weber-Carstens S, Menk M, Graw JA. Lower versus higher hemoglobin threshold for transfusion in ARDS patients with and without ECMO. Crit Care. 2020 Dec 16;24(1):697. doi: 10.1186/s13054-020-03405-4.

Reference Type DERIVED
PMID: 33327953 (View on PubMed)

Other Identifiers

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RECETTA

Identifier Type: -

Identifier Source: org_study_id

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