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NCT Number: NCT04094428

Burden, Mortality and Supply Costs in Intensive Care Unit Patients

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).

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Key information

Conditions

Burden, Dependency Critically Ill Patient End-of-life Care Frailty Intensive Care Unit Mortality Multiple Organ Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

  • Endpoint burden of care due to Clinical Frailty Scale (Frailty) high 7 - 9 intermediate 5 - 6 low 1 - 4
  • 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%
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No

Treatment and study plan

Primary outcomes

  1. Burden of care

    Time frame: 18 months

    Organ dysfunctions supported or replaced in numbers

  2. Mortality

    Time frame: 18 months

    Dying patients in numbers

  3. Supply costs

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Eberhard Barth, MD

CONTACT

[email protected]

+49 - (0)731-500 ext. 60233

Manfred Weiss, MD, MBA

CONTACT

[email protected]

+49 - (0)731-500 ext. 60226

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Official study title

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

Acronym: PLV_Ulm

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2019
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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