The Intensive Care Platform 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). 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.

Conditions

• Intensive Care Patients
• Intensive Care Unit Patients
• Critical Illness

Interventions

DRUG

Albumin

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.

OTHER

No 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.

DRUG

LMWH 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.

DRUG

LMWH 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.

DRUG

LMWH 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark

  collaborator OTHER

• Bispebjerg Hospital

  collaborator OTHER

• Herlev Hospital

  collaborator OTHER

• Hillerod Hospital, Denmark

  collaborator OTHER

• Kolding Sygehus

  collaborator OTHER

• Zealand University Hospital

  collaborator OTHER

• Slagelse Hospital

  collaborator OTHER

• Viborg Regional Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Gødstrup Hospital

  collaborator OTHER

• Copenhagen University Hospital, Hvidovre

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Randers Regional Hospital

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• North Denmark Region

  collaborator OTHER_GOV

• Region Capital Denmark

  collaborator OTHER

• Region Zealand

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• Steno Diabetes Center Copenhagen

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• University Hospital, Basel, Switzerland

  collaborator OTHER

• Tampere University

  collaborator OTHER

• Collaboration of Research in Intensive Care

  collaborator UNKNOWN

• Danish Intensive Care Database

  collaborator UNKNOWN

• The National University Hospital of Iceland

  collaborator UNKNOWN

• Anders Perner

  lead OTHER

Principal Investigators

• Anders Perner, Professor · Copenhagen University Hospital - Rigshospitalet, Department of Intensive Care

• Anders Granholm, MD · Copenhagen University Hospital - Rigshospitalet, Department of Intensive Care

• Morten H Moeller, Professor · Copenhagen University Hospital - Rigshospitalet, Department of Intensive Care

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-26

Primary Completion

2035-12-31

Completion

2035-12-31

Countries

• Denmark

Study Locations