The Intensive Care Platform Trial (INCEPT)
- Conditions
- Acute critical illness requiring intensive care unit admission.
- Interventions
- Drug: AlbuminOther: No albumin use
- Registration Number
- 2024-516208-41-00
- Lead Sponsor
- Anders Perner
- Brief Summary
The Intensive Care Platform Trial (INCEPT) will assess the effects of interventions used in adults acutely admitted to the intensive care unit.
INCEPT will primarily focus on interventions in common use where practice differs among clinicians, but other interventions may similarly be assessed on the platform.
- Detailed Description
Background:
Randomised clinical trials (RCTs) are the gold standard for evaluating intervention effects, however, conventional RCTs are bureaucratic, costly, inflexible, and often inconclusive. Adaptive platform trials are increasingly used as they can reduce barriers and are more flexible, and thus come with a higher probability of obtaining conclusive results faster at lower costs.
Objectives:
The Intensive Care Platform Trial (INCEPT) will be used to assess the effects of interventions used in adults acutely admitted to the intensive care unit (ICU).
Design:
INCEPT is an investigator-initiated, pragmatic, randomised, embedded, multifactorial, international, adaptive platform trial. INCEPT uses adaptive stopping and arm-dropping rules, as well as fixed and response-adaptive randomisation. Specific domains may be either open label or blinded.
Domains and interventions:
Comparable groups of interventions will be nested in domains, which have conceptual similarities with stand-alone randomised trials. Domains will continuously be added to INCEPT and conducted following domain-specific appendices to the core protocol.
Inclusion and exclusion criteria:
Adults acutely admitted to the ICU will be screened if they are eligible for at least one active domain. The only platform-level exclusion criteria are 1) informed consent after inclusion expected to be unobtainable and 2) patients admitted under coercive measures. Additional inclusion and exclusion criteria will be domain-specific.
Stakeholder involvement:
Stakeholder involvement is central in INCEPT and ensured through a central advisory board comprising various key stakeholders, and consultations with national and international research panels consisting of ICU survivors, family members, clinicians, and researchers. Stakeholders will be involved in the development of the overall platform trial and specific domains with pre-specified minimum requirements for involvement.
Outcomes:
Each domain will use one of the core outcomes (defined elsewhere in the registration) as the primary outcome and the guiding outcome driving all adaptations.
Statistical methods Primary analyses will generally be conducted in the intention-to-treat population of each domain. INCEPT primarily uses Bayesian statistical methods with neutral priors conveying either minimal information or some scepticism, although specific domains may use conventional, frequentist statistical methods. Outcomes will generally be analysed using logistic and linear regression models adjusted for pre-specified anticipated prognostic baseline characteristics, followed by calculation of sample-average estimates and intervention effects using G-computation. Results will be presented for each intervention and comparisons presented on both the absolute (risk differences and mean differences) and relative (risk ratios and ratios of means) scales with 95% credible intervals and probabilities of superiority. INCEPT will generally use constant, symmetric stopping rules for superiority/inferiority based on the guiding outcome; domains may use stopping rules for practical equivalence or futility based on the posterior distribution of the guiding outcome on the absolute scale. All stopping rules will be binding. Response-adaptive randomisation, either with or without restrictions, may be used based on the posterior distribution for the guiding outcome. Missing data will be multiply imputed. Additional secondary analyses (e.g., per-protocol analyses), sensitivity analyses, and analyses of heterogeneity in intervention effects according to pre-defined baseline characteristics may be specified for each domain and undertaken once a domain has stopped. Domains will be designed and evaluated using statistical simulation.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Not specified
- Target Recruitment
- 10000
Adult patient (≥18 years old) acutely admitted to the ICU.
Eligible for at least one active domain.
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Albumin Albumin Use 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 No albumin use No albumin is to be used in ICU unless specific events occur
- Primary Outcome Measures
Name Time Method Each domain in INCEPT will use one of the outcomes listed below under 'secondary end points' as the primary - the primary outcome will thus differ between domains, but always be one of the secondary outcomes (the core outcome set defined in the core protocol). Each domain in INCEPT will use one of the outcomes listed below under 'secondary end points' as the primary - the primary outcome will thus differ between domains, but always be one of the secondary outcomes (the core outcome set defined in the core protocol).
- Secondary Outcome Measures
Name Time Method All-cause 30-day mortality All-cause 30-day mortality
All-cause 90-day mortality All-cause 90-day mortality
All-cause 180-day mortality All-cause 180-day mortality
Days alive without life support at day 30 Days alive without life support at day 30
Days alive without life support at day 90 Days alive without life support at day 90
Days alive out of hospital at day 30 Days alive out of hospital at day 30
Days alive out of hospital at day 90 Days alive out of hospital at day 90
Days free of delirium at day 30 Days free of delirium at day 30
EQ-5D-5L index values (health-related quality of life) at day 180 EQ-5D-5L index values (health-related quality of life) at day 180
EQ VAS (health-related quality of life) at day 180 EQ VAS (health-related quality of life) at day 180
Cognitive function at day 180 (Montreal Cognitive Assessment test 5-minute version, v2.1 [“Mini MoCA”]) Cognitive function at day 180 (Montreal Cognitive Assessment test 5-minute version, v2.1 [“Mini MoCA”])
One or more domain-specific safety outcomes One or more domain-specific safety outcomes
Trial Locations
- Locations (19)
Anaesthesia, Hospital Sønderjylland
🇩🇰Aabenraa, Denmark
Department of Anaesthesia and Intensive Care, Aalborg University Hospital
🇩🇰Aalborg, Denmark
Department of Intensive Care Nord , Aarhus University Hospital
🇩🇰Aarhus, Denmark
Department of Intensive Care Øst, Aarhus University Hospital
🇩🇰Aarhus, Denmark
Department of Cardiothoracic Anaesthesia and Intensive care, Copenhagen Universisty Hospital - Rigshospitalet
🇩🇰Copenhagen, Denmark
Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet
🇩🇰Copenhagen, Denmark
Neuroanaesthesiology, Copenhagen University Hospital - Rigshospitalet
🇩🇰Copenhagen, Denmark
Department of anesthesiology and intensive care, Bispebjerg-Frederiksberg Hospital
🇩🇰Copenhagen, Denmark
Department of Anesthesiology and Intensive Care, Copenhagen University Hospital Herlev
🇩🇰Herlev, Denmark
Department of Anaesthesiology and Intensive Care, Gødstrup Hospital
🇩🇰Herning, Denmark
Scroll for more (9 remaining)Anaesthesia, Hospital Sønderjylland🇩🇰Aabenraa, DenmarkTorben F Jørgensen, MDPrincipal Investigator