Retrospective analysis in Quality of Life - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Quality of Life

Intervention / Treatment

Other: retrospective analysis

Detailed Description

Decisions to limit life-support therapy are common on the intensive care unit (ICU). End-of-life decisions (EOLD) underlie a dynamic process and limitation of ICU-therapies is done sequentially. Questionnaire-based and observational studies on medical ICUs and in palliative care reveal blood transfusions as the first therapy physicians withhold in EOLDs. Whether this practice also applies to surgical ICU-patients is unknown.

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.

Study Type

Observational

Enrollment (Actual)

226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

ADULT
OLDER_ADULT
CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

All patients discharged alive from the ICU

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sequence of withdrawing life-sustaining treatment Time Frame: 3 years	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
factors associated with the withholding of specific ICU-therapies Time Frame: 3 years	Approximately 200 patients will be enrolled in the study. They are followed up until their death on the ICU. In 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

August 9, 2015

First Submitted That Met QC Criteria

August 11, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Estimate)