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Recruiting NCT04094428

Burden, Mortality and Supply Costs in Intensive Care Unit Patients

Observational Burden, Dependency Mortality End-of-life Care Intensive Care Unit

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Burden, Dependency, Mortality, End-of-life Care, Intensive Care Unit. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Burden, Mortality and Supply Costs in Intensive Care Unit Patients. Health Services Research.

Overview

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).

Detailed 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

Primary outcome measures

  • Burden of care [Time frame: 18 months]
  • Mortality [Time frame: 18 months]
  • Supply costs [Time frame: 18 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • No

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Department of Anaesthesiology, University Hospital Ulm — Ulm

Identifiers

NCT: NCT04094428 · Anae_ICU_Ulm_PLV

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗