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

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

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).

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Manfred Weiss, MD, MBA; Phone Number: 60226 +49 - (0)731-500; Email: manfred.weiss@uniklinik-ulm.de
• Study Contact Backup: Name: Eberhard Barth, MD; Phone Number: 60233 +49 - (0)731-500; Email: eberhard.barth@uniklinik-ulm.de

Study Locations

• Germany
  • Ulm, Germany, 89075
    • Recruiting
    • Department of Anaesthesiology, University Hospital Ulm
    • Contact: Elisabeth M Schneider, PhD; Phone Number: 49 (0)731-500-60319; Email: marion.schneider@uni-ulm.de
    • Contact: Manfred E Weiss, MD; Phone Number: 49 (0)731-500-60226; Email: manfred.weiss@uniklinik-ulm.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients admitted to the intensive care unit, mainly surgical and polytraumatized patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Intensive care unit patient; All intensive care unit patients staying for at least 72 hours on the ICU and patients dying within 72 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Burden of care	Organ dysfunctions supported or replaced in numbers	18 months
Mortality	Dying patients in numbers	18 months
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

Collaborators and Investigators

• Sponsor: University of Ulm
• Investigators: Principal Investigator: Manfred Weiss, MD, MBA, University Hospital Medical School

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2019
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: intensive care unit; frailty; mortality; critically ill patient; burden; end-of-life care; Multiple Organ Failure
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Shock; Death; Frailty; Critical Illness; Multiple Organ Failure
• Other Study ID Numbers: Anae_ICU_Ulm_PLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No