The Intensive Care Platform Trial (INCEPT)

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Anaesthesia, Hospital Sønderjylland
NOT_YET_RECRUITING
Aabenraa
Department of Anaesthesia and Intensive Care, Aalborg University Hospital
RECRUITING
Aalborg
Department of Intensive Care Nord , Aarhus University Hospital
NOT_YET_RECRUITING
Aarhus
Department of Intensive Care Øst, Aarhus University Hospital
NOT_YET_RECRUITING
Aarhus
Department of anesthesiology and intensive care, Bispebjerg-Frederiksberg Hospital
NOT_YET_RECRUITING
Copenhagen
Department of Cardiothoracic Anaesthesia and Intensive care, Copenhagen Universisty Hospital - Rigshospitalet
NOT_YET_RECRUITING
Copenhagen
Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet
RECRUITING
Copenhagen
Neuroanaesthesiology, Copenhagen University Hospital - Rigshospitalet
NOT_YET_RECRUITING
Copenhagen
Department of Anesthesiology and Intensive Care, Copenhagen University Hospital Herlev
NOT_YET_RECRUITING
Herlev
Department of Anaesthesiology and Intensive Care, Gødstrup Hospital
NOT_YET_RECRUITING
Herning
Department of Anaesthesia and Intensive Care Medicine, Copenhagen University Hospital - North Zealand
NOT_YET_RECRUITING
Hillerød
Anaesthesiology and Intensive Care, Amager and Hvidovre Hospital
NOT_YET_RECRUITING
Hvidovre
Department of Anesthesia, Zealand University Hospital
RECRUITING
Køge
Department of Anesthesia and intensive care medicine, Kolding Hospital
RECRUITING
Kolding
Anesthesiology (ICU), Zealand University Hospital, Nykøbing Falster
NOT_YET_RECRUITING
Nykøbing Falster
Department of Anesthesiology and Intensive Care, Odense University Hospital
RECRUITING
Odense
Operation og Intensiv, Regional Hospital Randers
NOT_YET_RECRUITING
Randers
Insive care, Slagelse Hospital
NOT_YET_RECRUITING
Slagelse
Department of Anaesthesiology and Intensive Care, Regional Hospital Viborg
NOT_YET_RECRUITING
Viborg
Contact Information
Primary
Anders Perner, Professor
anders.perner@regionh.dk
004535458333
Backup
Morten H Moeller, Professor
morten.hylander.moeller@regionh.dk
004535458685
Time Frame
Start Date: 2025-06-26
Estimated Completion Date: 2035-12
Participants
Target number of participants: 10000
Treatments
Experimental: 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
Other: No albumin use
No albumin is to be used in ICU unless specific events occur
Sponsors
Collaborators: Bispebjerg Hospital, Karolinska Institutet, Slagelse Hospital, Viborg Regional Hospital, Kolding Sygehus, Section of Biostatistics University of Copenhagen, Copenhagen, Danish Intensive Care Database, The National University Hospital of Iceland, Aarhus University Hospital, Region Capital Denmark, Region Zealand, Aalborg University Hospital, Copenhagen University Hospital, Hvidovre, Rigshospitalet, Denmark, University Medical Center Groningen, North Denmark Region, Zealand University Hospital, Steno Diabetes Center Copenhagen, Odense University Hospital, Randers Regional Hospital, Tampere University, Collaboration of Research in Intensive Care, University Hospital, Basel, Switzerland, Herlev Hospital, Gødstrup Hospital, Oslo University Hospital, Hillerod Hospital, Denmark
Leads: Anders Perner

This content was sourced from clinicaltrials.gov