Criteria of Vulnerability Clinical Trial
Official title:
Impact of a Computer-assisted Tool to Help Reflection on the Decision to Withhold or to Withdraw Treatments for Surgical Patients in Intensive Care Units
Rationale: Medicalized end of life rose profound society questions and debates. Major Laws
and scientific society recommendations emerged from those reflections. These texts help
withholding/withdrawing life-sustaining treatments allowing a palliative approach and to
favor comfort treatments for end of life patients.
Main Objective: To evaluate the impact of a procedure to support reflection on the level of
therapeutic involvement for surgical patient (who undergone surgery or not) in ICU after
having identified vulnerability criteria early.
Secondary objectives: To assess the usual care of the control group and the impact of the
procedure according to ICU type (medical, surgical, mixed); the characteristics of surgical
patients concerned by a palliative strategy; the impact of an incentive approach on length
of mechanical ventilation and length of stay in the ICU; To measure the extent of
information collected concerning the collegial process; the impact of the procedure on
caregivers' satisfaction; To count the number of identified conflicts Study type:
Prospective, controlled, cluster randomized study of routine care Purpose: Study the
implementation of the Act "Leonetti" released on 22 April 2005 calling for a compassionate
approach and palliative care for patients at end of life.
Inclusion criteria: Surgical patients (who undergone surgery or not) hospitalized in ICU
during the study period Non-inclusion criteria: Patients hospitalized less than 24h;
non-surgical patients; patients who don't need ICU care or surveillance; minors; brain-dead
patients (at the time of admission) Primary endpoint: Rate of deaths with palliative
strategy (withholding or withdrawing treatments) Randomization process: each center is
randomized adjusting on type of ICU (medical, surgical, mixed) and number of annual
hospitalization volume.
- Control group: ICU usual care
- Intervention group: vulnerability criteria lead to reflection on level of therapeutic
involvement, with the help of a written guide.
Number of patients: 2750 surgical patients Number of centers: 45 Study design: usual data
will be collected in a secured web-based Case Report Form (CRF) at ICU admission and each
time therapeutic strategy will change. Additional data will be collected for the
intervention group according to the initial presence or the later apparition of predefined
criteria, a standardized reflection procedure will start helped by the implementation of a
guide for collegial approach and decision making.
Length: 30 months
n/a