Intensive care platform to test treatments for adults
The Intensive Care Platform Trial (INCEPT)
This project will test different commonly used treatments to see which help adults who are acutely admitted to the ICU.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 21 sites (Aabenraa and 20 other locations) |
| Trial ID | NCT06667999 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) who are acutely admitted to an intensive care unit and are eligible for at least one active domain are ideal candidates.
Not a fit: Patients who are not eligible for any currently active domain, those admitted under coercive measures, or where informed consent after inclusion is expected to be unobtainable are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the platform could lead to quicker identification of treatments that improve survival and long-term quality of life for ICU patients while stopping harmful or ineffective practices.
How similar studies have performed: Yes—similar adaptive platform trials such as REMAP-CAP and RECOVERY have identified effective ICU treatments, demonstrating that the approach can produce rapid, practice-changing results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aabenraa and 20 other locations
- Anaesthesia, Hospital Sønderjylland — Aabenraa, Denmark (Not_yet_recruiting)
- 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 Cardiothoracic Anaesthesia and Intensive care, Copenhagen Universisty Hospital - Rigshospitalet — Copenhagen, Denmark (Not_yet_recruiting)
- Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Neuroanaesthesiology, Copenhagen University Hospital - Rigshospitalet — Copenhagen, Denmark (Not_yet_recruiting)
- Department of anesthesiology and intensive care, Bispebjerg-Frederiksberg Hospital — Copenhagen, Denmark (Recruiting)
- Esbjerg Hospital — Esbjerg, Denmark (Not_yet_recruiting)
- Department of Anesthesiology and Intensive Care, Copenhagen University Hospital Herlev — Herlev, Denmark (Not_yet_recruiting)
- Department of Anaesthesiology and Intensive Care, Gødstrup Hospital — Herning, Denmark (Recruiting)
- Department of Anaesthesia and Intensive Care Medicine, Copenhagen University Hospital - North Zealand — Hillerød, Denmark (Recruiting)
- Anaesthesiology and Intensive Care, Amager and Hvidovre Hospital — Hvidovre, Denmark (Recruiting)
- Department of Anesthesia and intensive care medicine, Kolding Hospital — Kolding, Denmark (Recruiting)
- Department of Anesthesia, Zealand University Hospital — Køge, Denmark (Recruiting)
- Anesthesiology (ICU), Zealand University Hospital, Nykøbing Falster — Nykøbing Falster, Denmark (Not_yet_recruiting)
- Department of Anesthesiology and Intensive Care, Odense University Hospital — Odense, Denmark (Recruiting)
- Operation og Intensiv, Regional Hospital Randers — Randers, Denmark (Recruiting)
- Intensive care, Slagelse Hospital — Slagelse, Denmark (Recruiting)
- Department. of Anesthesiology and Intensive Care Medicine — Svendborg, Denmark (Recruiting)
- Department of Anaesthesiology and Intensive Care, Regional Hospital Viborg — Viborg, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.