Criteria of Vulnerability Clinical Trial
— LATAREA-IVOfficial 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
| Verified date | June 2017 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 1172 |
| Est. completion date | December 2015 |
| Est. primary completion date | January 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Surgical patients (who undergone surgery or not) hospitalized in ICU during the study period - No opposition to the use of data collected from the patient or a relative or inclusion in emergency and non-opposition collected offline Exclusion Criteria: - Patients admitted legally dead or brain-dead |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital FOCH | Suresnes |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
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Sprung CL, Cohen SL, Sjokvist P, Baras M, Bulow HH, Hovilehto S, Ledoux D, Lippert A, Maia P, Phelan D, Schobersberger W, Wennberg E, Woodcock T; Ethicus Study Group. End-of-life practices in European intensive care units: the Ethicus Study. JAMA. 2003 Aug 13;290(6):790-7. — View Citation
Truog RD, Cist AF, Brackett SE, Burns JP, Curley MA, Danis M, DeVita MA, Rosenbaum SH, Rothenberg DM, Sprung CL, Webb SA, Wlody GS, Hurford WE. Recommendations for end-of-life care in the intensive care unit: The Ethics Committee of the Society of Critical Care Medicine. Crit Care Med. 2001 Dec;29(12):2332-48. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants dead with palliative strategy | Rate of death with collegial process and withdrawing/withholding treatment | From ICU hospitalization to 6 months after inclusion | |
| Secondary | Impact of the procedure according to ICU type | From ICU hospitalization to 6 months after inclusion | ||
| Secondary | Characteristics of surgical patients concerned by a palliative strategy | From ICU hospitalization to 6 months after inclusion | ||
| Secondary | Impact of an incentive approach on length of mechanical ventilation and length of stay in the ICU. | From ICU hospitalization to 6 months after inclusion | ||
| Secondary | Extent of information collected concerning the collegial process | From ICU hospitalization to 6 months after inclusion | ||
| Secondary | Impact of the procedure on caregivers' satisfaction | From ICU hospitalization to 6 months after inclusion | ||
| Secondary | Number of identified conflicts | From ICU hospitalization to 6 months after inclusion |