Study Evaluating Multifaceted Support for the Implementation of Recommendations for the Prevention and Management of Anemia in Intensive Care Units

ConditionAnemia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • implementation of recommendations

    Other intervention

    The 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

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
Day 0 to Day 90

Secondary outcomes

1

Evaluate the impact of implementation support on Hb levels

hemoglobin level in g/dl

Time frame
hospital discharge or day 28
2

Assess the impact of implementation support on recovery after ICU discharge.

number of days living in the previous place of residence prior to D90

Time frame
Day 90
3

Evaluate impact of implementation support on longer-term mortality

all-cause mortality at 6 months

Time frame
6 Months
4

Assess the impact of implementation support on survival

6-month survival curves

Time frame
6 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: