Burden, Mortality and Supply Costs in Intensive Care Unit Patients

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04094428

Acronym

PLV_Ulm

Enrollment

700

Registered

2019-09-19

Start date

2019-10-21

Completion date

2026-09-30

Last updated

2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

burden, mortality, end-of-life care, intensive care unit, critically ill patient, frailty, Multiple Organ Failure

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Burden of care	18 months	Organ dysfunctions supported or replaced in numbers
Mortality	18 months	Dying patients in numbers
Supply costs	18 months	Costs in sum of Simplified Acute Physiology Score (SAPS) II score points over ICU stay; Costs in sum of points of organ support over ICU stay; Costs in Euro reimbursed for the ICU stay

Countries

Germany

Contacts

Primary ContactManfred Weiss, MD, MBA

manfred.weiss@uniklinik-ulm.de+49 - (0)731-500

Backup ContactEberhard Barth, MD

eberhard.barth@uniklinik-ulm.de+49 - (0)731-500

Outcome results