Burden, DependencyPLV_UlmNCT04094428
Burden, Mortality and Supply Costs in Intensive Care Unit Patients
An observational study of Burden, Dependency and Mortality, run by University of Ulm at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burden, Dependency, Mortality, End-of-life Care
- How many people
- 700 participants
- Where
- 1 siteGermany
- Study dates
- 21 Oct 2019to 30 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Critically ill patients admitted to the intensive care unit, mainly surgical and polytraumatized patients
Who may be able to join
- All patients dying on the ICU and all patients staying for at least 72 hours on the ICU
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Anaesthesiology, University Hospital Ulm
Ulm, 89075
Manfred E Weiss, MD, 49 (0)731-500-60226, manfred.weiss@uniklinik-ulm.de
Elisabeth M Schneider, PhD, 49 (0)731-500-60319, marion.schneider@uni-ulm.de
About this study
Official title: 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).
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
- 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
- Conditions
- Burden, Dependency, Mortality, End-of-life Care, Intensive Care Unit, Critically Ill Patient, Frailty
- Keywords
- burden, mortality, end-of-life care, intensive care unit, critically ill patient, frailty, Multiple Organ Failure
- Medical subject headings
- Frailty, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Burden of care
Organ dysfunctions supported or replaced in numbers
Measured: 18 months
Mortality
Dying patients in numbers
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start21 Oct 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burden, DependencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manfred Weiss, University of Ulm
- Investigators
- Manfred Weiss, MD, MBA, Principal investigator, University Hospital Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094428
- Sponsor's protocol ID
- Anae_ICU_Ulm_PLV
- Acronym
- PLV_Ulm
- Status last verified
- Jan 2024
- First submitted
- 12 Sep 2019
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden, Mortality and Supply Costs in Intensive Care Unit Patients. Health Services Research.
- ClinicalTrials.gov ID
- NCT04094428
- Acronym / sponsor ID
- PLV_Ulm / Anae_ICU_Ulm_PLV
- Conditions
- Burden, Dependency, Mortality, End-of-life Care, Intensive Care Unit, Critically Ill Patient, Frailty
- Keywords
- burden, mortality, end-of-life care, intensive care unit, critically ill patient, frailty, Multiple Organ Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive care unit patient | – | –All intensive care unit patients staying for at least 72 hours on the ICU and patients dying within 72 hours |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critically ill patients admitted to the intensive care unit, mainly surgical and polytraumatized patients
Key inclusion criteria (1 listed)
- All patients dying on the ICU and all patients staying for at least 72 hours on the ICU
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Burden of care
Time frame: 18 months
Organ dysfunctions supported or replaced in numbers
Mortality
Time frame: 18 months
Dying patients in numbers
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Weiss, MD, MBA principal investigator
University Hospital Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burden, Dependency and Mortality, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manfred Weiss, MD, MBA (+49 - (0)731-500 ext. 60226, manfred.weiss@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burden of care (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.