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Critical IllnessUPSt_UCINCT07510776

UP STUDY - Decipher Persistent Critical Illness Through in Deep Clinical Phenotyping.

An observational study of Critical Illness and Recovery Outcomes, run by Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa at 7 sites in Portugal.

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

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
7,000 participants
Where
7 sitesPortugal
Study dates
13 Jan 2025to 31 Dec 2027
Phase
Observational
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

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.

Who may be able to join

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

Who cannot join

  • 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).

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

7 sites in 1 country

Portugal7 sites, 7 recruiting
  • Centro Hospitalar de São João / ULS São João

    Lisbon, Lisbon District

    José Artur Paiva, MD PhD, 351 225 512 100, japaiva@ulssjoao.min-saude.pt

    José Artur Paiva, MD PhD

    Recruiting
  • Hospital de Vila Franca de Xira / ULS Estuário do Tejo

    Lisbon, Lisbon District

    João Gonçalves Pereira, MD PhD, 351 263 006 500, joaogpster@gmail.com

    João Gonçalves Pereira, MD PhD

    Recruiting
  • Hospital Garcia de Orta / ULS Almada-Seixal

    Lisbon, Lisbon District

    Antero Fernandes, MD PhD, 351 212 940 294, antevafe@gmail.com

    Antero Fernandes, MD PhD

    Recruiting
  • Hospital Prof. Doutor Fernando Fonseca / ULS Amadora -Sintra

    Lisbon, Lisbon District

    Paulo Teles Freitas, MD PhD, 351 214 348 200, ptf@netcabo.pt

    Paulo Teles Freitas, MD PhD

    Recruiting
  • Hospital Santa Maria / ULS Santa Maria

    Lisbon, Lisbon District

    Susana Fernandes, MD PhD, 351 217 805 000, susanamfernandes@medicina.ulisboa.pt

    Mariana Santos, PhD, marianamsantos@medicina.ulisboa.pt

    Recruiting
  • Hospital São Francisco Xavier / Centro Hospitalar de Lisboa Ocidental

    Lisbon, Lisbon District

    Pedro Póvoa, MD PhD, 351 210 431 000, pedrorpovoa@gmail.com

    Pedro Póvoa, MD PhD

    Recruiting
  • Hospital de VIla Nova de Gaia-Espinho / ULS Gaia e Espinho

    Vila Nova de Gaia, Porto District

    Rute Alves, MD PhD, ruteifalves@gmail.com

    Rute Alves, MD PhD

    Not yet recruiting

Other trials in Portugal

About this study

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.

Read more

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.

Keywords
Persistant Critical Illness, Critical care, Critical Illness
Medical subject headings
Critical Illness

What participants receive

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

Study groups in NCT07510776
Study groupRoleWhat they receive
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.

What is being measured

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

  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.

    Measured: The first 10 days in the ICU

Secondary outcomes (2)
  1. All cause mortality stratified by Persistent Critical Illness (PCI) clusters

    Clinical outcomes will be assessed and reported according to clusters of Persistent Critical Illness (PCI) identified using unsupervised machine learning analysis at Day 10 of ICU stay. Outcome includes:

    • All-cause mortality, reported as the proportion of participants who die during hospitalization and up to 1 year after cluster identification.

    Measured: From cluster identification (Day 10) until hospital discharge or up to 1-year follow-up if available.

  2. Organ dysfunction stratified by Persistent Critical Illness

    Clinical outcomes will be assessed and reported according to clusters of Persistent Critical Illness (PCI) identified using unsupervised machine learning analysis at Day 10 of ICU stay. Outcome includes:

    • Organ dysfunction, assessed using the Sequential Organ Failure Assessment (SOFA) score, reported as mean (± SD) or median (IQR) values after cluster identification.

    Measured: From cluster identification (Day 10) until hospital discharge or up to 1-year follow-up if available.

Timeline

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

  1. First posted3 Apr 2026
  2. Study start13 Jan 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
7,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07510776
Sponsor's protocol ID
UP STUDY
Acronym
UPSt_UCI
Status last verified
Mar 2026
First submitted
3 Dec 2025
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data collected in this study will be made available to other researchers. All data will undergo a thorough anonymization process prior to sharing to prevent direct or indirect identification of participants. Each patient will be assigned an internal numeric code, consisting of two digits representing the center of origin and four sequential digits assigned by order of admission. No personal identifiers (e.g., name, national ID number, full date of birth, address) are collected. The anonymized dataset will be accompanied by a data dictionary, describing each variable and its format, to allow full interpretation and reuse of the data. This approach ensures participant confidentiality and complies with ethical and legal requirements, while enabling secondary analyses, replication studies, or meta-analyses by other researchers.

Publications

  • Fuest KE, Ulm B, Daum N, Lindholz M, Lorenz M, Blobner K, Langer N, Hodgson C, Herridge M, Blobner M, Schaller SJ. Clustering of critically ill patients using an individualized learning approach enables dose optimization of mobilization in the ICU. Crit Care. 2023 Jan 3;27(1):1. doi: 10.1186/s13054-022-04291-8.

    PubMed 36597110
  • Shaw M, Viglianti EM, McPeake J, Bagshaw SM, Pilcher D, Bellomo R, Iwashyna TJ, Quasim T. Timing of Onset, Burden, and Postdischarge Mortality of Persistent Critical Illness in Scotland, 2005-2014: A Retrospective, Population-Based, Observational Study. Crit Care Explor. 2020 Apr 29;2(4):e0102. doi: 10.1097/CCE.0000000000000102. eCollection 2020 Apr.

    PubMed 32426744
  • Voiriot G, Oualha M, Pierre A, Salmon-Gandonniere C, Gaudet A, Jouan Y, Kallel H, Radermacher P, Vodovar D, Sarton B, Stiel L, Brechot N, Preau S, Joffre J; la CRT de la SRLF. Chronic critical illness and post-intensive care syndrome: from pathophysiology to clinical challenges. Ann Intensive Care. 2022 Jul 2;12(1):58. doi: 10.1186/s13613-022-01038-0.

    PubMed 35779142
  • Inoue S, Hatakeyama J, Kondo Y, Hifumi T, Sakuramoto H, Kawasaki T, Taito S, Nakamura K, Unoki T, Kawai Y, Kenmotsu Y, Saito M, Yamakawa K, Nishida O. Post-intensive care syndrome: its pathophysiology, prevention, and future directions. Acute Med Surg. 2019 Apr 25;6(3):233-246. doi: 10.1002/ams2.415. eCollection 2019 Jul.

    PubMed 31304024
  • Pereira RA, Sousa M, Cidade JP, Melo L, Lopes D, Ventura S, Aragao I, Lima Neto RMF, Molinos E, Marques A, Cardoso N, Marino F, Monteiro FB, Oliveira AP, Silva RC, Real AMN, Banheiro BS, Reis R, Adao-Serrano M, Cracium A, Valadas A, Ribeiro JM, Povoa P, Tapadinhas C, Mendes V, Coelho L, Maia R, Freitas PT, Ferreira IA, Ramires T, Val-Flores LS, Cascao M, Alves R, Rodeia SC, Barrigoto C, Cardiga R, Silva MJFD, Vale B, Fonseca T, Rios AL, Camoes J, Perez D, Cabral S, Ribeiro MI, Mendes JJ, Gouveia J, Fernandes SM. What changed between the peak and plateau periods of the first COVID-19 pandemic wave? A multicentric Portuguese cohort study in intensive care. Rev Bras Ter Intensiva. 2022 Oct-Dec;34(4):433-442. doi: 10.5935/0103-507X.20210037-pt. Epub 2023 Mar 3.

    PubMed 36888823
  • Livingston E, Bucher K. Coronavirus Disease 2019 (COVID-19) in Italy. JAMA. 2020 Apr 14;323(14):1335. doi: 10.1001/jama.2020.4344. No abstract available.

    PubMed 32181795
  • Cadd M, Nunn M. An A-E assessment of post-ICU COVID-19 recovery. J Intensive Care. 2021 Mar 20;9(1):29. doi: 10.1186/s40560-021-00544-w.

    PubMed 33743819
  • Gupta E, Jacobs MD, George G, Roman J. Beyond the ICU: Frailty and Post-ICU Disability. Healthcare Use after Acute Respiratory Distress Syndrome and Severe Sepsis. Am J Respir Crit Care Med. 2019 Apr 15;199(8):1028-1030. doi: 10.1164/rccm.201805-0928RR. No abstract available.

    PubMed 30849230
  • COVID-ICU Group on behalf of the REVA Network and the COVID-ICU Investigators. Clinical characteristics and day-90 outcomes of 4244 critically ill adults with COVID-19: a prospective cohort study. Intensive Care Med. 2021 Jan;47(1):60-73. doi: 10.1007/s00134-020-06294-x. Epub 2020 Oct 29.

    PubMed 33211135
  • Yildirim S, Durmaz Y, San Y, Taskiran I, Cinleti BA, Kirakli C. Cost of Chronic Critically Ill Patients to the Healthcare System: A Single-center Experience from a Developing Country. Indian J Crit Care Med. 2021 May;25(5):519-523. doi: 10.5005/jp-journals-10071-23804.

    PubMed 34177170
  • Span LF, Hermus AR, Bartelink AK, Hoitsma AJ, Gimbrere JS, Smals AG, Kloppenborg PW. Adrenocortical function: an indicator of severity of disease and survival in chronic critically ill patients. Intensive Care Med. 1992;18(2):93-6. doi: 10.1007/BF01705039.

    PubMed 1613205
  • Harrison DA, Creagh-Brown BC, Rowan KM. Timing and burden of persistent critical illnessin UK intensive care units: An observational cohort study. J Intensive Care Soc. 2023 May;24(2):139-146. doi: 10.1177/17511437211047180. Epub 2021 Nov 5.

    PubMed 37260430
  • Zhou Q, Qian H, Yang A, Lu J, Liu J. CLINICAL AND PROGNOSTIC FEATURES OF CHRONIC CRITICAL ILLNESS/PERSISTENT INFLAMMATION IMMUNOSUPPRESSION AND CATABOLISM PATIENTS: A PROSPECTIVE OBSERVATIONAL CLINICAL STUDY. Shock. 2023 Jan 1;59(1):5-11. doi: 10.1097/SHK.0000000000002035. Epub 2022 Nov 17.

    PubMed 36383370

Questions about this trial

What is this clinical trial studying?

An observational study of Critical Illness and Recovery Outcomes, run by Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa at 7 sites in Portugal.

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

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. 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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Portugal. 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.

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 Susana Fernandes, MD PhD. (351 21 798 5100, susanamfernandes@medicina.ulisboa.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Need for one or more continuous organ support treatment at Day 10 (time frame: The first 10 days in the ICU). 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 NCT07510776, which also lists 13 linked publications.

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 13 Apr 2026.

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