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Burden, Mortality and Supply Costs in Intensive Care Unit Patients (PLV_Ulm)

U

University of Ulm

Status

Enrolling

Conditions

Multiple Organ Failure
Mortality
Burden, Dependency
Critically Ill Patient
Intensive Care Unit
Frailty
End-of-life Care

Study type

Observational

Funder types

Other

Identifiers

NCT04094428
Anae_ICU_Ulm_PLV

Details and patient eligibility

About

This study systematically observes in a pragmatic trail under real world conditions the association between strategies of therapy (maximal therapy, withhold, withdraw) and treatment success in three endpoint related initial risk groups (high, intermediate, low risk) regarding three endpoints (burden, mortality and supply costs).

Full description

This study systematically observes in a pragmatic trail under real world conditions the association between strategies of therapy (maximal therapy, withhold, withdraw) and treatment success in three endpoint related initial risk groups (high, intermediate, low risk) regarding three endpoints (burden, mortality and supply costs).

The 3 endpoints and 3 respective risk groups (high, intermediate, low) are

  1. Endpoint burden of care due to Clinical Frailty Scale (Frailty) high 7 - 9 intermediate 5 - 6 low 1 - 4
  2. Endpoint mortality due to severity of disease regarding Simplified Acute Physiology Score (SAPS) II score values high SAPS II > 70, suspected mortality > 40% intermediate SAPS II > 40 - 70, suspected mortality 10 - 40% low SAPS II ≤ 40, suspected mortality < 10%
  3. Endpoint supply costs due to number of organ systems to be supported or replaced high ≥ 3 organ systems replaced intermediate 1 - 2 organ systems replaced low 0 - 2 organ systems replaced

Enrollment

700 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients dying on the ICU and all patients staying for at least 72 hours on the ICU

Exclusion criteria

  • No

Trial design

700 participants in 1 patient group

Intensive care unit patient
Description:
All intensive care unit patients staying for at least 72 hours on the ICU and patients dying within 72 hours

Trial contacts and locations

1

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Central trial contact

Manfred Weiss, MD, MBA; Eberhard Barth, MD

Data sourced from clinicaltrials.gov

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