Burden, Mortality and Supply Costs in Intensive Care Unit Patients

Frailty Clinical Trial

— PLV_Ulm  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04094428
• Other study ID #: Anae_ICU_Ulm_PLV
• Status: Recruiting
• Start date: October 21, 2019
• Est. completion date: September 30, 2026

Study information

• Verified date: January 2024
• Source: University of Ulm
• Contact: Manfred Weiss, MD, MBA
• Phone: +49 - (0)731-500
• Email: manfred.weiss[@]uniklinik-ulm.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: September 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology, University Hospital Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Burden of care	Organ dysfunctions supported or replaced in numbers	18 months
Primary	Mortality	Dying patients in numbers	18 months
Primary	Supply costs	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	18 months