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

• Sponsor: University of Ulm (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04094428
• Collaborator: (none)
• Enrollment: 700
• Location: 1
• Anticipated Duration (Months): 23.3
• Patients Per Site Per Month: 30

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Burden, Dependency; Mortality; End-of-life Care; Intensive Care Unit; Critically Ill Patient; Frailty; Multiple Organ Failure

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 Design

• Study Type: Observational
• Anticipated Enrollment: 700 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Burden, Mortality and Supply Costs in Intensive Care Unit Patients. Health Services Research.
• Actual Study Start Date: Oct 21, 2019
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Intensive care unit patient All intensive care unit patients staying for at least 72 hours on the ICU and patients dying within 72 hours

Outcome Measures

Primary Outcome Measures

1. Burden of care [18 months]

   Organ dysfunctions supported or replaced in numbers

2. Mortality [18 months]

   Dying patients in numbers

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• No

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anaesthesiology, University Hospital Ulm	Ulm		Germany	89075

Sponsors and Collaborators

• University of Ulm

Investigators

• Principal Investigator: Manfred Weiss, MD, MBA, University Hospital Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Manfred Weiss, Professor, MD, University of Ulm
• ClinicalTrials.gov Identifier: NCT04094428
• Other Study ID Numbers: Anae_ICU_Ulm_PLV
• First Posted: Sep 19, 2019
• Last Update Posted: Apr 10, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Manfred Weiss, Professor, MD, University of Ulm: burden; mortality; end-of-life care; intensive care unit; critically ill patient; frailty; Multiple Organ Failure
• Additional relevant MeSH terms: Critical Illness; Frailty; Death; Multiple Organ Failure

Study Results

No Results Posted as of Apr 10, 2020