About this trial
STOP-A is a prospective, multicenter data study aimed at demonstrating the impact of multifaceted support for the implementation of recommendations on the prevention and management of anemia in intensive care, compared to previous practices, on hospital mortality in adult patients hospitalized in intensive care for ≥2 days. The timing of implementation in each center is determined randomly by stepped-wedge randomization.
As such, this is a pragmatic study that meets the international PRECIS-2 criteria.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Length of stay in intensive care is ≥ 2 days
The patient has at least one organ failure lasting 24 hours or more (catecholamine infusion and/or mechanical ventilation (invasive or NIV > 6 hours/day))
No objection to data collection (patient or relative)
Disqualifiers
Terminally ill patient with limited active treatment options within 72 hours of admission.
Trial population
adult patients hospitalized in intensive care for ≥2 days
Trial design
Other
Prospective
Treatments tested in this trial
implementation of recommendations
Other interventionThe study will be organized into three periods: * a pre-implementation phase, with no changes to usual care; * a period of implementation of the recommendations; * a post-implementation phase.
Treatment groups
Trial outcomes
Primary outcomes
evaluate the impact of multifaceted support for STOP-A implementation on hospital mortality, taking into account the stepped wedge design structure.
in-hospital mortality, up to day 90
Secondary outcomes
Evaluate the impact of implementation support on Hb levels
hemoglobin level in g/dl
Assess the impact of implementation support on recovery after ICU discharge.
number of days living in the previous place of residence prior to D90
Evaluate impact of implementation support on longer-term mortality
all-cause mortality at 6 months
Assess the impact of implementation support on survival
6-month survival curves
Sponsors and contacts
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