RecruitingPhase 4NCT06667999

The Intensive Care Platform Trial

The Intensive Care Platform Trial (INCEPT)


Sponsor

Anders Perner

Enrollment

10,000 participants

Start Date

Jun 26, 2025

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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.
  • 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.

Exclusion Criteria5

  • 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).

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Interventions

DRUGAlbumin

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.

OTHERNo albumin use

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.

DRUGLMWH in weight-adjusted dose

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.

DRUGLMWH in fixed low dose

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.

DRUGLMWH in fixed intermediate dose

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.


Locations(21)

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

Esbjerg Hospital

Esbjerg, Denmark

Department of Anesthesiology and Intensive Care, Copenhagen University Hospital Herlev

Herlev, Denmark

Department of Anaesthesiology and Intensive Care, Gødstrup Hospital

Herning, Denmark

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

Hillerød, Denmark

Anaesthesiology and Intensive Care, Amager and Hvidovre Hospital

Hvidovre, Denmark

Department of Anesthesia and intensive care medicine, Kolding Hospital

Kolding, Denmark

Department of Anesthesia, Zealand University Hospital

Køge, Denmark

Anesthesiology (ICU), Zealand University Hospital, Nykøbing Falster

Nykøbing Falster, Denmark

Department of Anesthesiology and Intensive Care, Odense University Hospital

Odense, Denmark

Operation og Intensiv, Regional Hospital Randers

Randers, Denmark

Intensive care, Slagelse Hospital

Slagelse, Denmark

Department. of Anesthesiology and Intensive Care Medicine

Svendborg, Denmark

Department of Anaesthesiology and Intensive Care, Regional Hospital Viborg

Viborg, Denmark

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NCT06667999