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RecruitingNCT04094428PLV_UlmUpdated Jan 17, 2024

Burden, Mortality and Supply Costs in Intensive Care Unit Patients

An observational study in Burden, Dependency, Mortality and End-of-life Care, sponsored by University of Ulm. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2024-01-17.

Sponsored by University of Ulm · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Oct 2019; still recruiting 7 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
700
Sex
All
01

Study 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).

Read the 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
02

Conditions studied

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

Keywords

  • burden
  • mortality
  • end-of-life care
  • intensive care unit
  • critically ill patient
  • frailty
  • Multiple Organ Failure
03

In context

Frailty

1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.

This study's planned enrollment of 700 is above the median of 225 across 493 observational studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

University of Ulm is the lead sponsor of 143 studies on the registry; 25 are open to participants now.

Browse University of Ulm studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • No
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
700 participants (estimated)
Patient registry
No

Groups and cohorts

  • Intensive care unit patient

    All intensive care unit patients staying for at least 72 hours on the ICU and patients dying within 72 hours

06

What researchers measure

Primary outcomes

  1. Burden of care

    Organ dysfunctions supported or replaced in numbers

    Time frame: 18 months

  2. Mortality

    Dying patients in numbers

    Time frame: 18 months

  3. 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

    Time frame: 18 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04094428
Lead sponsor
University of Ulm
Responsible party
Manfred Weiss (Professor, MD, University of Ulm) — Principal investigator
First posted
Sep 19, 2019
Start date
Oct 21, 2019
Primary completion
Dec 31, 2025 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Jan 17, 2024

Study contacts

Manfred Weiss, MD, MBA
Contact
manfred.weiss@uniklinik-ulm.de
+49 - (0)731-500 ext. 60226
Eberhard Barth, MD
Contact
eberhard.barth@uniklinik-ulm.de
+49 - (0)731-500 ext. 60233
Manfred Weiss, MD, MBA
principal investigator · University Hospital Medical School

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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