Intensive care platform to test treatments for adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

INCEPT is an investigator-initiated, pragmatic, randomized, embedded, multifactorial, adaptive platform that enrolls adults acutely admitted to intensive care. The platform runs multiple parallel domains (each comparing related interventions such as albumin use or different low-molecular-weight heparin doses), with some domains open-label and others blinded. The design uses adaptive stopping and arm-dropping rules plus fixed and response-adaptive randomization to find effective or harmful interventions faster and with fewer resources. Domains are added over time and conducted under domain-specific appendices to the core protocol.

Why it matters

Who can join: the full rules

The general eligibility criteria below apply to INCEPT as a whole and thus to all domains. Domains may impose domain-specific eligibility criteria that restrict the population eligible for that domain further, but domains are not allowed to broaden the general eligibility criteria. Domain-specific eligibility criteria always apply to all arms in a domain.

PLATFORM INCLUSION CRITERIA:

* Adult patient (≥18 years old) acutely admitted to the ICU. This includes ICU admissions after emergency surgery, unplanned ICU admissions after elective surgery, and prolonged ICU admissions due to complications after elective surgery (i.e., admissions occurring or being prolonged due to an unexpected, worsened condition, but excluding planned ICU admissions after elective surgery without clinical deterioration).
* Eligible for at least one active domain.

PLATFORM EXCLUSION CRITERIA:

* Informed consent following inclusion expected to be unobtainable (e.g., known previous objections to participation).
* Patient is under coercive measures (e.g., ongoing involuntary hospital stay or under the jurisdiction of correctional authorities).

Patients who have previously been included in INCEPT may only be included again during new ICU admissions but may only be randomised to domains in which they have not previously been randomised.

DOMAIN-SPECIFIC ELIGIBLE CRITERIA:

Each domain may have additional eligibility criteria. Refer to the study website for more information (www.incept.dk).

Where it's running

• Department of Anaesthesia and Intensive Care, Aalborg University Hospital
  Aalborg, Denmark Recruiting
• Department of Intensive Care Nord , Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Department of Intensive Care Øst, Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet
  Copenhagen, Denmark Recruiting
• Department of anesthesiology and intensive care, Bispebjerg-Frederiksberg Hospital
  Copenhagen, Denmark Recruiting
• Department of Anaesthesiology and Intensive Care, Gødstrup Hospital
  Herning, Denmark Recruiting

Study contacts

• Principal investigator: Anders Granholm, MD — Copenhagen University Hospital - Rigshospitalet, Department of Intensive Care
• Study coordinator: Anders Perner, Professor
• Email: anders.perner@regionh.dk
• Phone: 004535458333

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.