Burden, Mortality and Supply Costs in Intensive Care Unit Patients

Recruiting

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

• Registration Number: NCT04094428
• Lead Sponsor: University of Ulm

Brief 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).

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

Study Timeline

• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2019-09-17
• Study First Posted: 2019-09-19
• Study Start: 2019-10-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-17
• Primary Completion: 2025-12-31
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

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

Exclusion Criteria

• No

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Anaesthesiology, University Hospital Ulm; 🇩🇪 Ulm, Germany