NCT04094428

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Oct 2019Sep 2026

First Submitted

Initial submission to the registry

September 12, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 21, 2019

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

6.2 years

First QC Date

September 12, 2019

Last Update Submit

January 16, 2024

Conditions

Burden, DependencyMortalityEnd-of-life CareIntensive Care UnitCritically Ill PatientFrailtyMultiple Organ Failure

Keywords

burdenmortalityend-of-life careintensive care unitcritically ill patientfrailtyMultiple Organ Failure

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Intensive care unit patient

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology, University Hospital Ulm

Ulm, 89075, Germany

RECRUITING

MeSH Terms

Conditions

FrailtyMultiple Organ Failure

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Manfred Weiss, MD, MBA

    University Hospital Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manfred Weiss, MD, MBA

CONTACT

+49 - (0)731-500manfred.weiss@uniklinik-ulm.de

Eberhard Barth, MD

CONTACT

+49 - (0)731-500eberhard.barth@uniklinik-ulm.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

September 12, 2019

First Posted

September 19, 2019

Study Start

October 21, 2019

Primary Completion

December 31, 2025

Study Completion (Estimated)

September 30, 2026

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)