The Intensive Care Platform Trial
INCEPT
3 other identifiers
interventional
10,000
1 country
21
Brief Summary
Among critically ill patients, many die, and many of the survivors and their family members struggle for years with reduced quality of life. Critically ill patients are treated in intensive care units (ICUs). Here, they receive life support, e.g., mechanical ventilation and advanced support of the circulation (heart and blood vessels) and kidneys. In addition, ICU patients receive many other treatments. It is, however, uncertain if all the treatments provide value for the patients. The desirable effects of many treatments are uncertain, and some may be wasteful or even harmful. Clinical trials are necessary to validly assess the desirable and undesirable effects of different treatments. However, conventional clinical trials have limitations:
- They typically only assess a single question related to a single comparison of treatments at a time.
- They are often not very flexible, including with regards to the number of participants needed, and this increases the risk that a trial will end up as inconclusive.
- There is no or limited re-use or sharing of infrastructure across trials, leading to duplicate work and resource use.
- Trial participants do usually not benefit from the obtained knowledge before the trial concludes.
- Involvement of patients, family members, and other stakeholders is typically limited, which may decrease the relevance of the questions addressed. With the Intensive Care Platform Trial (INCEPT), we aim to tackle these challenges by establishing a flexible platform trial that continuously learns from the obtained results. The platform trial may run forever with simultaneous and continuous assessment of many treatments. INCEPT will continuously learn from the accrued data and use these to improve the treatment of both participating and future patients. With INCEPT, we are also building a framework for thorough and extensive involvement of key stakeholders, including patients and family members. INCEPT will improve the way clinical trials are done and increase the probabilities that treatments are improved. This will:
- Directly improve outcomes for ICU patients.
- Relieve a strained healthcare system by discarding inefficient or harmful treatments.
- Ensure that new treatments are beneficial or cost-effective before implementation.
- Lower the costs and burdens of assessing more treatments in the critically ill.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2025
Longer than P75 for phase_4
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2024
CompletedFirst Posted
Study publicly available on registry
October 31, 2024
CompletedStudy Start
First participant enrolled
June 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2035
March 19, 2026
February 1, 2026
10.4 years
October 25, 2024
March 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
One of the INCEPT core outcomes (varying between domains)
Each domain in INCEPT will use one of the core outcomes; 1. All-cause 30-day mortality. 2. All-cause 90-day mortality. 3. All-cause 180-day mortality. 4. Days alive without life support at day 30. 5. Days alive without life support at day 90. 6. Days alive out of hospital at day 30. 7. Days alive out of hospital at day 90. 8. Days free of delirium at day 30. 9. EQ VAS (Health-Related Quality of Life) at day 180. 10. EQ-5D-5L index values (Health-related quality of life) at day 180. 11. Cognitive function at day 180 (all described under "secondary outcomes").
From randomisation to 30-180 days after randomisation.
Days alive without life support at day 30 (Albumin domain)
Days alive without the use of life support, with life support defined as invasive mechanical ventilation (≥1 hour of ventilation through a cuffed tube), continuous (i.e., ≥1 hour) use of vasopressors/inotropes, use of renal replacement therapy (including any form of in-hospital renal replacement therapy \[e.g., haemodialysis, haemofiltration, or haemodiafiltration\], continuously or intermittently, and including days in between intermittent renal replacement therapy; pauses between renal replacement therapy of up to three days will be considered as days receiving intermittent renal replacement therapy) at hospitals. Integer (0-30 overall; 0-29 in domains with life support at baseline as an eligibility criterion).
From randomisation to 30 days after randomisation.
Days alive and out of hospital at day 30 (Thromboprophylaxis domain)
Days alive and out of hospital. Rehabilitation facilities and nursing homes do not count as hospitals. Integer 0-29.
From randomisation to 30 days after randomisation.
Secondary Outcomes (12)
All-cause 30-day mortality
30 days after randomisation.
All-cause 90-day mortality
90 days after randomisation.
All-cause 180-day mortality
180 days after randomisation.
Days alive without life support at day 30
From randomisation to 30 days after randomisation.
Days alive without life support at day 90
From randomisation to 90 days after randomisation.
- +7 more secondary outcomes
Other Outcomes (2)
Albumin domain-specific safety outcomes
30 days (matching the primary and guiding outcome) and 90 days (matching the maximum intervention period.
Thromboprophylaxis domain-specific safety outcomes
30 days (matching the primary and guiding outcome) and 90 days (matching the maximum intervention period).
Study Arms (5)
Albumin
EXPERIMENTALUse of albumin in ICU during circulatory failure in addition to crystalloids (resuscitation) and for substitution in case of suspected or overt albumin loss or plasma albumin levels ≤25 g/L
No albumin use
OTHERNo albumin is to be used in ICU unless specific events occur
Low-molecular-weight heparin for thromboprophylaxis in weight-adjusted dose
EXPERIMENTALUse of low-molecular-weight heparin for thromboprophylaxis in weight-adjusted dose during ICU stay
Low-molecular-weight heparin for thromboprophylaxis in fixed low dose
ACTIVE COMPARATORUse of low-molecular-weight heparin for thromboprophylaxis in fixed low dose during ICU stay
Low-molecular-weight heparin for thromboprophylaxis in fixed intermediate dose
ACTIVE COMPARATORUse of low-molecular-weight heparin for thromboprophylaxis in fixed intermediate dose during ICU stay
Interventions
Albumin should be used for the following indications: 1. During circulatory failure in addition to crystalloids (resuscitation). 2. For substitution in case of: suspected or overt albumin loss OR P-albumin levels below or equal to 25 g/L. Decisions around timing, volume, and concentration of albumin, and its use for other indications, are at the clinician's discretion. P-albumin should be measured according to local practice.
Albumin should not be used. In case of the following special circumstances, albumin may be considered: 1. Large ascites drainage (i.e., equal to or more than 1 L tapped) 2. Spontaneous bacterial peritonitis 3. Hepatorenal syndrome.
Patients with indication for thromboprophylaxis receive low-molecular-weight heparin (LMWH) in a weight-adjusted dose during their ICU stay. The treating clinician may decide to adjust or withhold one or more doses in case of acute and/or chronic kidney injury, renal replacement therapy, thrombocytopenia, invasive procedures, use of thrombolysis, and active (major) bleeding.
Patients with indication for thromboprophylaxis receive low-molecular-weight heparin (LMWH) in a fixed low dose during their ICU stay. The treating clinician may decide to adjust or withhold one or more doses in case of acute and/or chronic kidney injury, renal replacement therapy, thrombocytopenia, invasive procedures, use of thrombolysis, and active (major) bleeding.
Patients with indication for thromboprophylaxis receive low-molecular-weight heparin (LMWH) in a fixed intermediate dose during their ICU stay. The treating clinician may decide to adjust or withhold one or more doses in case of acute and/or chronic kidney injury, renal replacement therapy, thrombocytopenia, invasive procedures, use of thrombolysis, and active (major) bleeding.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anders Pernerlead
- Rigshospitalet, Denmarkcollaborator
- Bispebjerg Hospitalcollaborator
- Herlev Hospitalcollaborator
- Hillerod Hospital, Denmarkcollaborator
- Kolding Sygehuscollaborator
- Zealand University Hospitalcollaborator
- Slagelse Hospitalcollaborator
- Viborg Regional Hospitalcollaborator
- Aalborg University Hospitalcollaborator
- Aarhus University Hospitalcollaborator
- Gødstrup Hospitalcollaborator
- Copenhagen University Hospital, Hvidovrecollaborator
- Odense University Hospitalcollaborator
- Randers Regional Hospitalcollaborator
- University of Copenhagencollaborator
- North Denmark Regioncollaborator
- Region Capital Denmarkcollaborator
- Region Zealandcollaborator
- University Medical Center Groningencollaborator
- Steno Diabetes Center Copenhagencollaborator
- Karolinska Institutetcollaborator
- Oslo University Hospitalcollaborator
- University Hospital, Basel, Switzerlandcollaborator
- Tampere Universitycollaborator
- Collaboration of Research in Intensive Carecollaborator
- Danish Intensive Care Databasecollaborator
- The National University Hospital of Icelandcollaborator
Study Sites (21)
Anaesthesia, Hospital Sønderjylland
Aabenraa, 6200, Denmark
Department of Anaesthesia and Intensive Care, Aalborg University Hospital
Aalborg, 9000, Denmark
Department of Intensive Care Nord , Aarhus University Hospital
Aarhus, 8200, Denmark
Department of Intensive Care Øst, Aarhus University Hospital
Aarhus, 8200, Denmark
Department of Cardiothoracic Anaesthesia and Intensive care, Copenhagen Universisty Hospital - Rigshospitalet
Copenhagen, 2100, Denmark
Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet
Copenhagen, 2100, Denmark
Neuroanaesthesiology, Copenhagen University Hospital - Rigshospitalet
Copenhagen, 2100, Denmark
Department of anesthesiology and intensive care, Bispebjerg-Frederiksberg Hospital
Copenhagen, 2400, Denmark
Esbjerg Hospital
Esbjerg, 6700, Denmark
Department of Anesthesiology and Intensive Care, Copenhagen University Hospital Herlev
Herlev, 2730, Denmark
Department of Anaesthesiology and Intensive Care, Gødstrup Hospital
Herning, 7400, Denmark
Department of Anaesthesia and Intensive Care Medicine, Copenhagen University Hospital - North Zealand
Hillerød, 3400, Denmark
Anaesthesiology and Intensive Care, Amager and Hvidovre Hospital
Hvidovre, 2650, Denmark
Department of Anesthesia and intensive care medicine, Kolding Hospital
Kolding, 6000, Denmark
Department of Anesthesia, Zealand University Hospital
Køge, 4600, Denmark
Anesthesiology (ICU), Zealand University Hospital, Nykøbing Falster
Nykøbing Falster, 4800, Denmark
Department of Anesthesiology and Intensive Care, Odense University Hospital
Odense, 5000, Denmark
Operation og Intensiv, Regional Hospital Randers
Randers, 8930, Denmark
Intensive care, Slagelse Hospital
Slagelse, 4200, Denmark
Department. of Anesthesiology and Intensive Care Medicine
Svendborg, 5700, Denmark
Department of Anaesthesiology and Intensive Care, Regional Hospital Viborg
Viborg, 8800, Denmark
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Anders Perner, Professor
Copenhagen University Hospital - Rigshospitalet, Department of Intensive Care
- PRINCIPAL INVESTIGATOR
Anders Granholm, MD
Copenhagen University Hospital - Rigshospitalet, Department of Intensive Care
- PRINCIPAL INVESTIGATOR
Morten H Moeller, Professor
Copenhagen University Hospital - Rigshospitalet, Department of Intensive Care
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Domains may be open-label or blinded (masked). Outcome assessment of health-related quality of life and cognitive function will always be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, senior staff specialist
Study Record Dates
First Submitted
October 25, 2024
First Posted
October 31, 2024
Study Start
June 26, 2025
Primary Completion (Estimated)
December 1, 2035
Study Completion (Estimated)
December 1, 2035
Last Updated
March 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- For each domain, data will generally only be shared after a grace period of at least 9 months following initial publication of results based on the data. Approved researchers will sign appropriate agreements to ensure compliance with the approved purpose and ethical and eventual legal requirements.
- Access Criteria
- Described in the core protocol which will be available at www.incept.dk once the trial has been approved.
An anonymised version of the final dataset (without personal, identifiable information, with timestamps replaced by relative time differences with respect to the time of randomisation, and other measures as deemed relevant) in each domain may be shared with other researchers following a reasonable request (i.e., a research proposal outlining the objectives, methodologies, and plans for data usage) and subsequent approval by the platform and domain management committees. Any sharing of data that is not considered anonymised will be after the necessary approvals; alternatively, aggregation, scrambling, or synthetic datasets (i.e., datasets with similar structure and attempts to preserve the overall relationships between variables as the original dataset) may be shared.