A Phase 4 interventional study of Albumin and No albumin use in Intensive Care Patients, Intensive Care Unit Patients and Critical Illness, sponsored by Anders Perner. Recruiting at 40 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Anders Perner · Phase 4, Interventional, and Treatment
Austria, Estonia, Finland, Iceland, Netherlands, Sweden
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:
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:
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.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 90 across 926 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Anders Perner is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
PLATFORM EXCLUSION CRITERIA:
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).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Albumin
No albumin is to be used in ICU unless specific events occur
Other: No albumin use
Use of low-molecular-weight heparin for thromboprophylaxis in weight-adjusted dose during ICU stay
Drug: LMWH in weight-adjusted dose
Use of low-molecular-weight heparin for thromboprophylaxis in fixed low dose during ICU stay
Drug: LMWH in fixed low dose
Use of low-molecular-weight heparin for thromboprophylaxis in fixed intermediate dose during ICU stay
Drug: LMWH in fixed intermediate dose
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.
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").
Time frame: 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).
Time frame: 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.
Time frame: From randomisation to 30 days after randomisation.
All-cause 30-day mortality
All-cause, fixed-time mortality. Binary.
Time frame: 30 days after randomisation.
All-cause 90-day mortality
All-cause, fixed-time mortality. Binary.
Time frame: 90 days after randomisation.
All-cause 180-day mortality
All-cause, fixed-time mortality. Binary.
Time frame: 180 days after randomisation.
Days alive without life support at day 30
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).
Time frame: From randomisation to 30 days after randomisation.
Days alive without life support at day 90
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 (0-90 overall; 0-89 in domains with life support at baseline as an eligibility criterion).
Time frame: From randomisation to 90 days after randomisation.
Days alive out of hospital at day 30
Days alive and out of hospital. Rehabilitation facilities and nursing homes do not count as hospitals. Integer 0-29.
Time frame: From randomisation to 30 days after randomisation.
Days alive out of hospital at day 90
Days alive and out of hospital. Rehabilitation facilities and nursing homes do not count as hospitals. Integer 0-89.
Time frame: From randomisation to 90 days after randomisation.
Days free of delirium at day 30
Days free of delirium. Days are not considered free of delirium in case of any of the following: a) any registered positive delirium score with a validated screening tool (Confusion Assessment Method for the Intensive Care Unit \[CAM-ICU\], CAM-ICU-7 or Intensive Care Delirium Screening Checklist \[ICDSC\]) b) new treatment with antipsychotics (any administration of haloperidol, olanzapine, or quetiapine in participants not receiving either of these at the time of index hospital admission) c) delirium status not evaluable due to mortality or registered coma. Integer (0-30 overall; 0-29 in domains with delirium at baseline as an eligibility criterion).
Time frame: From randomisation to 30 days after randomisation.
EQ-5D-5L index values (Health-Related Quality of Life) at day 180
EQ-5D-5L instrument with responses across five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with five response levels each. Used with a value set to calculate index values anchored at 1 (perfect health) and 0 (a health state considered as bad as being dead) with index values below 0 representing health states worse than death. Preferably completed by participants, but completed by proxies if participants are unable to answer (using the proxy-participant perspective, i.e., the proxy will answer from the participant's perspective as the limited, indirect data available indicates that this perspective may better correspond to the participant's own response, if available). Decimal number (minimum values depend on value sets used, e.g., -0.758 with the Danish value set; maximum value: 1.000).
Time frame: 180 days after randomisation (+/- 14 days).
EQ VAS (Health-Related Quality of Life) at day 180
A visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state), part of the EQ-5D-5L instrument
Time frame: 180 days after randomisation (+/- 14 days).
Cognitive function at day 180
Montreal Cognitive Assessment test 5-minute version, v2.1 ("Mini MoCA"), ranging from 0 points (worst) to 15 points (best).
Time frame: 180 days after randomisation (+/- 14 days).
Thromboprophylaxis domain specific secondary outcomes
The number of participants with one or more domain-specific secondary outcomes, i.e., venous thromboembolism or major bleeding as specified in the domain-specific appendix.
Time frame: 30 days (matching the primary and guiding outcome) and 90 days (matching the maximum intervention period).
Albumin domain-specific safety outcomes
Albumin domain: The number of participants with one or more safety outcomes, i.e. severe anaphylatic reaction or major bleedings as specified in the domain specific appendix.
Time frame: 30 days (matching the primary and guiding outcome) and 90 days (matching the maximum intervention period.
Thromboprophylaxis domain-specific safety outcomes
The number of participants with one or more safety outcomes, i.e. severe anaphylactic reaction to LMWH or heparin-induced thrombocytopenia as specified in the domain specific appendix.
Time frame: 30 days (matching the primary and guiding outcome) and 90 days (matching the maximum intervention period).
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
Data sharing details ↗ · incept.dk
Started Jun 2025 (actual). Primary completion is estimated for Dec 2035, 126 months after the start.
Of 36 non-industry phase 4 interventional studies under Critical Illness, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 41. This study's planned 126 months is above that.
Counting every sponsor, half of 36 studies reached it within 30 months; a quarter within 16 and three quarters within 41.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
Austria, Estonia, Finland, Iceland, Netherlands, Sweden
Austria, Estonia, Finland, Iceland, Netherlands, Sweden
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Albumins
Anders Perner