Brief Summary

Persistent Critical Illness (PCI) is a condition that affects some patients who remain in the Intensive Care Unit (ICU) for a long time, usually more than 10-14 days. It is estimated to occur in 5-20% of critically ill patients. A recent Portuguese study found that more than 14% of ICU patients stayed longer than 14 days. PCI is often associated with ongoing need for life support, such as mechanical ventilation or medications to maintain blood pressure. However, patients may also experience severe muscle weakness, repeated infections, or other complications, which makes this group very diverse. One of the main risk factors for prolonged ICU stay is sepsis, a severe infection that affects the whole body. Other factors-such as prior health conditions, use of corticosteroids, sedation practices, early versus late mobilization, fluid and antibiotic management, and delirium treatment-may also influence the development and course of PCI. This study aims to identify different clinical patterns ("clusters") among critically ill patients who remain in the ICU for more than 10 days. Patients will be followed until hospital discharge, and up to one year if data are available. Understanding these different patterns will help develop more personalized and effective care strategies for each patient profile. The study is a multicenter retrospective cohort including adult patients (≥18 years) admitted to participating ICUs for more than 5 days between 2021 and 2023. Data collected will include demographic, clinical, and laboratory information, details of organ support (such as mechanical ventilation or vasopressors), medications, nutrition, and rehabilitation practices. Statistical and machine learning methods will be used to identify groups of patients with similar clinical trajectories and to assess how these groups are related to outcomes such as survival, recovery of organ function, or long-term disability. Expected results are the identification of distinct clinical clusters of PCI that combine clinical and laboratory data, and the development of tailored management strategies to improve recovery and outcomes for patients with PCI.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

7,000

participants targeted

Target at P75+ for all trials

Timeline

19mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach

1 country

7 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3 years study duration

Study Progress48%

Jan 2025Dec 2027

Study Start

First participant enrolled

January 13, 2025

Completed

11 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2025

Completed

4 months until next milestone

First Posted

Study publicly available on registry

April 3, 2026

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

December 3, 2025

Last Update Submit

April 8, 2026

Conditions

Recovery Outcomes Critical Care, Intensive Care Critical Care Critical Care Medicine Critical Illness

Keywords

Persistant Critical IllnessCritical careCritical Illness

Outcome Measures

Primary Outcomes (1)

Need for one or more continuous organ support treatment at Day 10
Data from patients who remain in the ICU for more than 10 days requiring ongoing organ support, such as invasive mechanical ventilation, renal replacement therapy or vasopressors, will be used to identify those who develop Persistent Critical Illness and to enable subsequent cluster analysis of their clinical trajectories.
The first 10 days in the ICU

Secondary Outcomes (2)

All cause mortality stratified by Persistent Critical Illness (PCI) clusters
From cluster identification (Day 10) until hospital discharge or up to 1-year follow-up if available.
Organ dysfunction stratified by Persistent Critical Illness
From cluster identification (Day 10) until hospital discharge or up to 1-year follow-up if available.

Other Outcomes (9)

ICU mortality
Through ICU stay (up to 1 year).
Hospital mortality
Through hospital stay (up to 2 years).
ICU length of stay
Through ICU stay (up to 1 year).
+6 more other outcomes

Study Arms (1)

Adult patients (≥18 years) admitted to participating ICUs for more than 5 days.

Adult patients (≥18 years) admitted to participating intensive care units (ICUs) who remained in the ICU for more than 5 days.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

This study will include adult patients (≥18 years old) who are consecutively admitted to participating intensive care units (ICUs) and remain in the ICU for 5 or more days. The focus will be on patients who survive the early phase of critical illness, allowing the formation of a relatively homogeneous cohort of early ICU survivors. The population will comprise patients with a wide range of critical illnesses, including sepsis, respiratory failure, cardiovascular instability, and multi-organ dysfunction, who require ongoing organ support such as invasive mechanical ventilation or vasopressors. Patients with prolonged ICU stays exceeding 10 days who continue to require organ support will be further characterized as having Persistent Critical Illness.

You may qualify if:

Adult patients aged 18 years or older;
ICU length of stay equal to or greater than 5 days.

You may not qualify if:

Patients with an ICU stay \< 5 days;
Patients discharged from the ICU early due to lack of ward availability, rather than clinical recovery;
Patients who do not survive the early phase of critical illness (i.e., early ICU deaths).

Contact the study team to confirm eligibility.