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Recruiting Not applicable

Rapid Response Teams - How and Who?

NCT04507737 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2021-09-01
Last updated
2025-09-17

Condition(s) studied

Hospital Rapid Response TeamEarly Warning ScoreIntensive Care Units

Investigational drug(s) / intervention(s)

Rapid Response Team Composition_ ICU Nurse

Rapid Response Team Composition_ ICU Nurse: In case of deterioration a Rapid Response Team may be activated. We will be examining the composition of the teams alternating between a MET or a CCOT.

Study summary

This will be an investigator initiated One-sided blinded Randomized Clinical Trial.

The study will examine the composition of the Rapid Response Team (RRT). the investigators will examine to see if a Critical Care Outreach Team (CCOT) consisting of an ICU-Nurse and a general ward physician and nurse are non-inferior to a Medical Emergency Team (MET) consisting of an ICU-Doctor and ICU Nurse as well as a general ward physician and nurse. The randomization will be done using an Analogue randomization sequence using sealed opaque envelopes with central randomization.The experimental intervention will be the CCOT. The statistical analyses will be done on the primary outcomes in the intention to treat population and on the secondary outcomes on an per-protocol basis exempting those with protocol violations.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Admitted to any general ward of the hospital AND * Aged ≥ 18 years AND * In need of RRT attention Exclusion Criteria: * Age \< 18 * Admitted to the delivery ward * Admitted to any ward in the anesthetic department * ICU * High Dependency Unit * Post Operation Department * Operating Theatre * Same Day Admissions - Surgery Ward * Not admitted at the time of call * Evaluation track in Emergency department (prior to being seen by a doctor) * Out-Patient departments * X-ray department * Any patient who cannot be randomized at the time of call

Primary outcome measure(s)

  • 30-Day Mortality — up to 30 days
    Binary outcome measured via the patient Electronic Medical Records
  • In-Hospital Cardiac Arrest (IHCA) — up to 30 days
    Binary outcome measured via the patient Electronic Medical Records: defined as any IHCA post randomization and until discharge or 30 days post randomization
  • Unplanned Admission to the Intensive Care Unit — up to 30 days
    Binary outcome measured via the patient Electronic Medical Records. Defined as Admission to the ICU more than 24h Post randomization until discharge or 30 day post randomization
  • Unexpected Death — up to 30 days
    Binary outcome measured via the Patient Electronic Medical Records and National Register of deaths in the population. Defined as Any deaths post randomization until discharge or 30 days post randomization without treatment limitation being implemented during or 24 hours after the RRT, and without a "do not attempt resuscitation" order

Trial sites (1)

FacilityCityRegionStatus
Nordsjællands Hospital Hillerød Danmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04507737 on ClinicalTrials.gov ↗ ← All trials in Denmark