AzTrials
AzTrials

Intensive Care PatientsPhase 4INCEPTNCT06667999

The Intensive Care Platform Trial

A Phase 4 study testing Albumin, No albumin use and LMWH in weight-adjusted dose in people with Intensive Care Patients and Intensive Care Unit Patients, run by Anders Perner at 40 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Albumin, No albumin use and LMWH in weight-adjusted dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10,000 participants
Where
40 sitesin 7 countries
Study dates
26 Jun 2025to Dec 2035
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Trial locations and contacts

40 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Anders Perner, Professor contact

004535458333

anders.perner@regionh.dk

Morten H Moeller, Professor contact

004535458685

morten.hylander.moeller@regionh.dk

40 sites in 7 countries

Denmark22 sites, 22 recruiting

  • Anaesthesia, Hospital Sønderjylland

    Aabenraa, 6200

    Rajesh P Bhavsar, MD, 004579970000, rajesh.prabhakar.bhavsar@rsyd.dk

    Rajesh P Bhavsar, MD

    Not yet recruiting

  • Department of Anaesthesia and Intensive Care, Aalborg University Hospital

    Aalborg, 9000

    Bodil S Rasmussen, Professor, MD, PhD, 004597661864, bodil.steen.rasmussen@rn.dk

    Olav L Schjørring, MD, PhD, o.schjoerring@rn.dk

    Recruiting

  • Department of Intensive Care Nord , Aarhus University Hospital

    Aarhus, 8200

    Klaus U Koch, MD, Consoultant, 004561686674

    Klaus U Koch, MD, Consultant

    Recruiting

  • Department of Intensive Care Øst, Aarhus University Hospital

    Aarhus, 8200

    Asger Granfeldt, MD, Professor, 004529720155, asgegran@rm.dk

    Asger Granfeldt, MD, Professor

    Recruiting

  • Department of Cardiothoracic Anaesthesia and Intensive care, Copenhagen Universisty Hospital - Rigshospitalet

    Copenhagen, 2100

    Theis S Itenov, MD, PhD, Professor, 004535450533, theis.skovsgaard.itenov@regionh.dk

    Peter B Hjortrup, MD, PhD, 004535451217, peter.buhl.hjortrup@regionh.dk

    Not yet recruiting

  • Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet

    Copenhagen, 2100

    Anders Perner, Professor, 004535458333, anders.perner@regionh.dk

    Morten H Moeller, Professor, 004535458685, morten.hylander.moeller@regionh.dk

    Recruiting

  • Neuroanaesthesiology, Copenhagen University Hospital - Rigshospitalet

    Copenhagen, 2100

    Kirsten Møller, MD, PhD, DMSc, Professor, 004535451616, kirsten.moeller.01@regionh.dk

    kirsten.moeller.01@regionh.dk

    Not yet recruiting

  • Department of anesthesiology and intensive care, Bispebjerg-Frederiksberg Hospital

    Copenhagen, 2400

    Nanna Reitter, MD, 004540146658, nanna.reitter@regionh.dk

    Nanna Reitter, MD

    Recruiting

  • Esbjerg Hospital

    Esbjerg, 6700

    Anders Storgaard, MD, 004579182645, anders.storgaard@rsyd.dk

    Anders Storgaard, MD

    Not yet recruiting

  • Department of Anesthesiology and Intensive Care, Copenhagen University Hospital Herlev

    Herlev, 2730

    Anne S Andreasen, MD, PhD, 004538681875, Anne.sofie.andreasen@regionh.dk

    Anne S Andreasen, MD, PhD

    Not yet recruiting

  • Department of Anaesthesiology and Intensive Care, Gødstrup Hospital

    Herning, 7400

    Iben S Darfelt, MD, 004548310086, ibedar@rm.dk

    Iben S Darfelt, MD

    Recruiting

  • Department of Anaesthesia and Intensive Care Medicine, Copenhagen University Hospital - North Zealand

    Hillerød, 3400

    Morten H Bestle, MD, 004541951195, morten.bestle@regionh.dk

    Morten H Bestle, MD

    Recruiting

  • Regional Hospital Horsens, Department of Anaesthesia, Surgery, and Intensive Care

    Horsens, 8700

    Henriette M Bach, MD, 004578425366, henrbc@rm.dk

    Henriette Michelsen Bach, MD

    Not yet recruiting

  • Anaesthesiology and Intensive Care, Amager and Hvidovre Hospital

    Hvidovre, 2650

    Ronni TR Plovsing, MD, PhD, 004538620721, ronni.thermann.reitz.plovsing.01@regionh.dk

    Ronni TR Plovsing, MD, PhD

    Recruiting

  • Department of Anesthesia, Zealand University Hospital

    Køge, 4600

    Lars Peter K Andersen, MD, Ph.D, +45 31518908, lpka@regionsjaelland.dk

    Louise S Herløv, Project nurse, +45 47 32 63 11, lherl@regionsjaelland.dk

    Recruiting

  • Department of Anesthesia and intensive care medicine, Kolding Hospital

    Kolding, 6000

    Anne C Brøchner, MD, Consultant, 004529464468, Anne.craveiro.broechner@rsyd.dk

    Anne C Brøchner, MD, Consultant

    Recruiting

  • Anesthesiology (ICU), Zealand University Hospital, Nykøbing Falster

    Nykøbing Falster, 4800

    Kim Z Rokamp, MD, 004520759779, kizr@regionsjaelland.dk

    Hans Fjeldsøe-Nielsen, MD, 004556515607, hafj@regionsjaelland.dk

    Not yet recruiting

  • Department of Anesthesiology and Intensive Care, Odense University Hospital

    Odense, 5000

    Jens Michelsen, MD, 004565413365, Jens.michelsen3@rsyd.dk

    Jens Michelsen, MD

    Recruiting

  • Operation og Intensiv, Regional Hospital Randers

    Randers, 8930

    Marianne L Vang, MD, 004578420505, marivang@rm.dk

    Marianne L Vang, MD

    Recruiting

  • Intensive care, Slagelse Hospital

    Slagelse, 4200

    Anne G Vedel, MD, Senior Registrar, 004560660882, agse@regionsjaelland.dk

    Susanne A Iversen, Leading Physician, 004524951801, saiv@regionsjaelland.dk

    Recruiting

  • Department. of Anesthesiology and Intensive Care Medicine

    Svendborg, 5700

    Peter M Hansen, MD, Consultant, +4520629319, peter.martin.hansen@rsyd.dk

    Peter Martin Hansen, MD, Consultant

    Recruiting

  • Department of Anaesthesiology and Intensive Care, Regional Hospital Viborg

    Viborg, 8800

    Christoffer G Sølling, MD, PhD, 004561787862, chrisl@rm.dk

    Christoffer Grant Sølling, MD, PhD

    Recruiting

Other trials in Denmark

Sweden5 sites, 5 recruiting

  • Intensive and Perioperative Care, Skane University Hospital

    Malmö, 20501

    Fredrik Sjövall, MD, Senior Consultant, +46 40 337664, Fredrik.sjovall@med.lu.se

    Fredrik Sjövall, MD, Senior Consultant

    Not yet recruiting

  • Perioperativ Medicin och Intensivvård, Karolinska Universitetssjukhuset

    Stockholm, Solna, 17177

    Johan Mårtensson, MD, Docent, 0709745476, johan.martensson@regionstockholm.se

    Johan Mårtensson, MD, Docent

    Not yet recruiting

  • Södersjukhuset Sachsska Barnsjukhuset, Department of Anesthesia and Intensive care

    Stockholm, 11883

    Anca C Balintescu, MD, 0046861692208, a.balintescu@regionstockholm.se

    Anca Cristina Balintescu, MD

    Not yet recruiting

  • Department of Anaesthesia and Intensive Care, Danderyd Hospital

    Stockholm, 18288

    Maria Cronhjort, MD, PhD, Ass. professor, Maria.cronhjort@regionstockholm.se

    Maria Cronhjort, MD, PhD, Ass. professor

    Not yet recruiting

  • Region Vaesternorrland, Department of Anesthesia and Intensive Care

    Sundsvall, 85643

    Erik Svensk, MD, 0046702515765, svensk.erik@gmail.com

    Erik Svensk, MD

    Not yet recruiting

Other trials in Sweden

Finland4 sites, 4 recruiting

  • Perioperative and Intensive Care,, Helsinki University Hospital

    Helsinki, 00029

    Erika Wilkman, MD, PhD, Ass. professor, 0504279155, Erika.wilkman@hus.fi

    Erika Wilkman, MD, PhD, Ass. professor

    Not yet recruiting

  • Department of Anesthesiology and Intensive Care, Hospital Nova of Central Finland

    Jyväskylä, 40620

    Nina Inkinen, MD, 0035358142695375, nina.inkinen@hyvaks.fi

    Nina Inkinen, MD

    Not yet recruiting

  • Department of Anaesthesiology and Intensive Care, Kuopio University Hospital

    Kuopio

    Matti Reinikainen, Professor, MD, PhD, 00358447176681, matti.reinikainen@pshyvinvointialue.fi

    Matti Reinikainen, Professor, MD, PhD

    Not yet recruiting

  • Anaesthesiology and Intensive Care Medicine, Tampere University Hospital

    Tampere, 33520

    Johanna Hästbacka, MD, Ass. professor, 00358 50 403 8373, Johanna.hastbacka@pirha.fi

    Johanna Hästbacka, MD, PhD, Ass. professor

    Not yet recruiting

Other trials in Finland

Netherlands4 sites, 4 recruiting

  • Critical Care, University Medical Center Groningen

    Groningen, 9713

    Frederik Keus, MD, PhD., 0503615617, f.keus@umcg.nl

    Frederik Keus, MD, PhD

    Recruiting

  • Intensive Care, Martini Hospital Groningen

    Groningen, 9728

    Marijn J Boer, MD, 0031505246540, boermj@MZH.nl

    Marijn Johannes Boer, MD

    Not yet recruiting

  • tensive Care Medicine, Maastricht UMC+

    Maastricht, 6229

    Bas C.T. van Bussel, MD, PhD., 0031(0)43-3876009, bas.van.bussel@mumc.nl

    Bas C.T van Bussel, MD, PhD

    Not yet recruiting

  • Anesthesiology and Intensive Care, Antonius Ziekenhuis Sneek

    Sneek, 8601

    A C Sauer, MD, PhD., 0031641488161, a.sauer@mijnantonius.nl

    A C Sauër, MD, PhD

    Not yet recruiting

Other trials in Netherlands

Estonia3 sites, 3 recruiting

  • East Tallinn Central Hospital, Centre of Anaesthesiology and Intensive Care

    Tallinn, 10138

    Maarja Hallik, MD, 003725055369, maarja.hallik@itk.ee

    Maarja Hallik, MD

    Not yet recruiting

  • North Estonia Medical Centre Foundation, Intensive Care Centre

    Tallinn, 13419

    Hans-Erik Ehrlich, MD, 003726171250, hans-erik.ehrlich@regionaalhaigla.ee

    Hans-Erik Ehrlich, MD

    Not yet recruiting

  • Tartu University Hospital, Anesthesiology and Intensive Care Clinic

    Tartu, 50406

    Pille Rennit, MD, 003727318412, Pille.Rennit@kliinikum.ee

    Pille Rennit, MD

    Not yet recruiting

Other trials in Estonia

Austria1 site, 1 recruiting

  • Medical University Of Vienna, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine

    Vienna, 1090

    Stefan J Schaller, MD, Professor, 0043014040041020, stefan.schaller@meduniwien.ac.at

    Stefan J Schaller, MD, Professor

    Not yet recruiting

Other trials in Austria

Iceland1 site, 1 recruiting

  • Department of Anaesthesiology and Critical Care Medicine, Landspitali - The National University Hospital of Iceland

    Reykjavik, 108

    Martin I Sigurðsson, Professor, Chief Physician, 003545431000, Martin@landspitali.is

    Martin Ingi Sigurðsson, Professor, Chief Physician

    Recruiting

Other trials in Iceland

About this study

Official title: The Intensive Care Platform Trial (INCEPT)

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:

Read more
  • 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.
Read the 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.

Being tested
Albumin, No albumin use, LMWH in weight-adjusted dose, LMWH in fixed low dose, LMWH in fixed intermediate dose
Keywords
Platform trial, Intensive care, Intensive care unit, Critical illness, Clinical platform trial
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlbuminDrug

    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.

  • No albumin useOther

    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.

  • LMWH in weight-adjusted doseDrug

    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.

  • LMWH in fixed low doseDrug

    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.

  • LMWH in fixed intermediate doseDrug

    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.

Study groups in NCT06667999
Study groupRoleWhat they receive
AlbuminExperimentalUse 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
Receives: Drug: Albumin
No albumin useOtherNo albumin is to be used in ICU unless specific events occur
Receives: Other: No albumin use
Low-molecular-weight heparin for thromboprophylaxis in weight-adjusted doseExperimentalUse of low-molecular-weight heparin for thromboprophylaxis in weight-adjusted dose during ICU stay
Receives: Drug: LMWH in weight-adjusted dose
Low-molecular-weight heparin for thromboprophylaxis in fixed low doseActive comparatorUse of low-molecular-weight heparin for thromboprophylaxis in fixed low dose during ICU stay
Receives: Drug: LMWH in fixed low dose
Low-molecular-weight heparin for thromboprophylaxis in fixed intermediate doseActive comparatorUse of low-molecular-weight heparin for thromboprophylaxis in fixed intermediate dose during ICU stay
Receives: Drug: LMWH in fixed intermediate dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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").

    Measured: From randomisation to 30-180 days after randomisation.

  2. 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).

    Measured: From randomisation to 30 days after randomisation.

  3. 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.

    Measured: From randomisation to 30 days after randomisation.

Secondary outcomes (12)

  1. All-cause 30-day mortality

    All-cause, fixed-time mortality. Binary.

    Measured: 30 days after randomisation.

  2. All-cause 90-day mortality

    All-cause, fixed-time mortality. Binary.

    Measured: 90 days after randomisation.

  3. All-cause 180-day mortality

    All-cause, fixed-time mortality. Binary.

    Measured: 180 days after randomisation.

  4. 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).

    Measured: From randomisation to 30 days after randomisation.

  5. 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).

    Measured: From randomisation to 90 days after randomisation.

  6. 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.

    Measured: From randomisation to 30 days after randomisation.

  7. 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.

    Measured: From randomisation to 90 days after randomisation.

  8. 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).

    Measured: From randomisation to 30 days after randomisation.

  9. 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).

    Measured: 180 days after randomisation (+/- 14 days).

  10. 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

    Measured: 180 days after randomisation (+/- 14 days).

  11. 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).

    Measured: 180 days after randomisation (+/- 14 days).

  12. 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.

    Measured: 30 days (matching the primary and guiding outcome) and 90 days (matching the maximum intervention period).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2024
  2. Study start26 Jun 2025
  3. Primary completionDec 2035 (estimated)
  4. Study completionDec 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised, embedded, multifactorial, adaptive, primarily Bayesian, domain-based platform trial.
Masking
None (open label)
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06667999
Sponsor's protocol ID
RH-ITA-2024-516208-41-00
Other IDs
2024-516208-41-00, U1111-1313-8171
Acronym
INCEPT
Status last verified
Oct 2026
First submitted
25 Oct 2024
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Albumin, No albumin use and LMWH in weight-adjusted dose in people with Intensive Care Patients and Intensive Care Unit Patients, run by Anders Perner at 40 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Denmark, Sweden, Finland, Netherlands, Estonia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anders Perner, Professor (004535458333, anders.perner@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

One of the INCEPT core outcomes (varying between domains) (time frame: From randomisation to 30-180 days after randomisation.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06667999.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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