NCT02521428

Brief Summary

The purpose of this retrospective observational study is to describe the sequence of ICU-therapies that are limited and to compare characteristics and the decision making process in surgical ICU-patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
226

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

Status
completed

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 Start

First participant enrolled

August 1, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

3.1 years

First QC Date

August 9, 2015

Last Update Submit

August 11, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • sequence of withdrawing life-sustaining treatment

    The primary objective of this study performed according to an observational post-ad-hoc design is to identify the sequence of withdrawing life-sustaining treatment in surgical ICU-patients with an end-of-life decision on an intensive care unit of a German academic medical center. Approximately 200 patients will be enrolled in the study. They are followed up until their death on the ICU. In clinical routine end-of-life decisions are documented for decision-makers and procedures in the patients´ records. Patients´ characteristics and therapeutic approaches are documented in the electronic patient data management system.

    3 years

Secondary Outcomes (1)

  • factors associated with the withholding of specific ICU-therapies

    3 years

Interventions

Approximately 200 patients will be enrolled in the study. They are followed up until their death on the ICU. In clinical routine end-of-life decisions are documented for decision-makers and procedures in the patients´ records. Patients´ characteristics and therapeutic approaches are documented in the electronic patient data management system.

Eligibility Criteria

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

All Surgical Intensive Care Department patients will be enrolled in the study

You may qualify if:

  • All surgical patients admitted to the ICU All surgical patients discharged death from the ICU

You may not qualify if:

  • All patients discharged alive from the ICU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

August 9, 2015

First Posted

August 13, 2015

Study Start

August 1, 2008

Primary Completion

September 1, 2011

Study Completion

August 1, 2015

Last Updated

August 13, 2015

Record last verified: 2015-08