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Post-Intensive Care Syndrome (PICS)NCT07828301

Post-ICU Syndrome and Social Determinants of Healths

An observational study of Post-Intensive Care Syndrome (PICS), run by Pontificia Universidad Catolica de Chile at 5 sites in Chile.

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

Medical intensive care has improved dramatically, and today, 70% to 80% of critically ill patients survive. However, several survivors face long-term psychological, cognitive, and/or physical sequelae after discharge and challenges in resuming their lives. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post-Intensive Care Syndrome (PICS)
How many people
400 participants
Where
5 sitesChile
Study dates
15 Sep 2025to 31 Mar 2029
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: Patients aged 18 years or older with critical illness who have been on a ventilator for at least 48 hours will be invited to participate in the study.

Who may be able to join

  • Patients 18 years of age or older
  • Patients with critical illness who have been on a ventilator for at least 48 hours

Who cannot join

  • Presence of mental or intellectual disability before hospitalization
  • Early limitation of therapeutic effort
  • Primary neurological injury (e.g., anoxic injury, stroke, or traumatic brain injury)
  • Anticipated death within 3 months of discharge (e.g., recommended palliative care)
  • Uncontrolled psychiatric illness at hospital admission
  • Communication limitations (e.g., does not speak Spanish)
  • Unlikely to adhere to follow-up (e.g., no fixed address, difficult to locate at follow-up)

Trial locations and contacts

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

Paula B Repetto, PhD contact

+56223549024

prepetto@uc.cl

Leyla M Alegria, PhD contact

lmalegri@uc.cl

5 sites in 1 country

Chile5 sites, 3 recruiting
  • Hospital Biprovincial de Quillota

    Quillota

    Active, not recruiting
  • Clínica San Carlos de Apoquindo

    Santiago

    Celia Flores, RN, cfloresb@ucchristus.cl

    Recruiting
  • Complejo Asistencial Dr. Sótero del Rio

    Santiago

    Carolina Ruiz, MD, ccruiz@uc.cl

    Recruiting
  • Hospital Clínico UC Christus

    Santiago

    Leyla Alegria, RN, MSc, PhD, lmalegr@uc.cl

    Recruiting
  • Hospital Las Higueras

    Talcahuano

    Active, not recruiting

Other trials in Chile

About this study

Official title: Post-ICU Syndrome: Exploring the Role of Social Determinants on Trajectories and Outcomes

Medical intensive care has improved dramatically, and today, 70% to 80% of critically ill patients survive. However, several survivors face long-term psychological, cognitive, and/or physical sequelae after discharge and challenges in resuming their lives. These conditions are known as Post-Intensive Care Syndrome (PICS). PICS is a multifaceted disorder that affects many patients who survive critical illness and receive treatment in the ICU. 'It can persist for weeks, months, and years after discharge, negatively affecting the quality of life of survivors and their families, generating financial consequences, and increasing the utilization of healthcare services. It can persist for weeks, months, and years after discharge, negatively affecting survivors' and their families' quality of life, creating financial burdens, and increasing healthcare utilization. Researchers have identified several PICS risk factors linked to sociodemographic and psychosocial conditions, including social support, isolation, and survivors' social position. Taken together, these findings highlight the role of social determinants of health (SDH) in explaining PICS and the different outcomes among survivors. We propose that applying an SDH framework can enhance understanding of PICS, its determinants, trajectories, and outcomes. Consequently, this study aims to examine the trajectories of PICS among ICU survivors and the role of SDH, including sociodemographic factors, social support, loneliness, perceived social position, among other factors, as well as the role of biomarkers and ICU treatments.

We will conduct a longitudinal cohort study with 400 patients from 5 different ICUs in Chile who received critical care. Patients will be evaluated based on sociodemographic factors and their treatment in the ICU, SDH measures, psychosocial factors, biomarkers, and PICS symptoms at discharge and at 3, 6, and 12 months. Latent class analysis (LCA) will identify distinct latent profiles based on patterns of PICS symptoms. It will then examine social determinants of health (SDH) as covariates to determine whether they are associated with different profiles. These results will contribute to our understanding of PICS and inform interventions to prevent it and support the recovery process among survivors.

Read the detailed description

In recent decades, advances in intensive care have substantially reduced mortality, with survival rates now ranging from 70 to 80% among critically ill patients. However, a considerable number of these survivors experience persistent sequelae after discharge from the intensive care unit (ICU), affecting their functionality, well-being, and ability to resume their everyday life. This set of sequelae has been conceptualized as Post-Intensive Care Syndrome (PICS), defined as the onset or worsening of physical, cognitive, and/or mental health impairments that develop after ICU hospitalization and persist beyond hospital discharge. PICS is a complex, multifactorial condition that can last for months or even years, significantly impacting the quality of life of survivors and their families. PICS encompasses a wide range of clinical manifestations. Physically, patients may experience muscle weakness, joint stiffness, decreased mobility, persistent fatigue, and difficulty performing activities of daily living. Cognitively, memory impairment, difficulty concentrating, deterioration of executive functions, and reduced attention span have been reported. Some patients also develop ICU-associated delirium, characterized by confusion, disorientation, and mental status changes. Symptoms of anxiety, depression, post-traumatic stress disorder (PTSD), and sleep disturbances are commonly reported psychological symptoms. These sequelae can reduce overall functional capacity, make it harder to return to work, and lead to loss of independence and impaired social participation, directly affecting the quality of life of patients and their caregivers. Prospective studies have shown that the consequences of PICS extend beyond the clinical setting, affecting occupational, social, and economic dimensions. In a UK cohort, one-third of survivors lost their jobs or retired within six months of discharge, and this proportion remained high at 12 months. In addition, a significant proportion required assistance with self-care, usually provided by family members, which negatively affected caregivers' employment and income. Persistent pain and fatigue were associated with a lower probability of returning to work.

Although PICS is highly prevalent, estimates vary considerably by population, definitions used, and timing of assessment after ICU discharge. Nevertheless, available evidence suggests that between 50% and 70% of intensive care survivors present one or more symptoms consistent with PICS; approximately six out of ten patients continue to experience at least one sequela a year after discharge. Physical impairments affect between 30% and 80% of patients, while cognitive impairment has been reported in ranges from 25% to 75%. In terms of mental health, the prevalence of anxiety and depression varies between 20% and 50%, and PTSD symptoms affect up to 20-30% of survivors. In addition, 30% to 60% have limitations in performing activities of daily living and reduced functional capacity, highlighting the magnitude of PICS's impact on long-term recovery.

Several risk factors for developing PICS have been identified, including advanced age, female gender, the presence of previous comorbidities, and lower educational or socioeconomic status. More broadly, these risk factors point to the relevance of social determinants of health (SDH), defined as the conditions in which people are born, grow, live, work, and age, as well as the social, economic, and political systems that shape these conditions, which are closely linked to health inequalities. Within this framework, perceived social position, an individual's subjective standing relative to others in society, distinct from objective indicators such as income or education, has emerged as a key determinant: survivors in lower social positions tend to present worse outcomes than those in higher positions. This is explained because social position translates into psychosocial factors such as social support, loneliness, and chronic stress, which are associated with the worst health outcomes.

Consistent with this perspective, research findings suggest that psychological and social factors play a central role in the development and persistence of PICS. The ICU experience can be traumatic, and post-discharge stressors-such as loss of independence, financial difficulties, and caregiving overload-can perpetuate symptoms. The negative impact on the health outcomes of survivors may be intensified due to the psychosocial conditions associated with the SDH, already present before hospitalization in the ICU; anxiety, depression, or PTSD during hospitalization, as well as a history of mental illness, increases the risk of persistent psychological sequelae.

In summary, despite the growing body of research on post-intensive care syndrome (PICS), it remains defined as a set of symptoms, despite the heterogeneity of the disorders patients present with. This approach limits our understanding of the condition and the design of interventions, as PICS encompasses multiple combinations of symptoms and trajectories of evolution. Identifying patient groups with different symptom profiles, along with associated factors and their evolution over time, can provide researchers and clinicians with the input needed to advance our understanding. Recognizing the influence of psychosocial factors described in the SDH model on post-ICU outcomes represents a promising avenue to advance this knowledge, building on available evidence, although mostly descriptive, that psychosocial factors contribute to PICS outcomes. Understanding how social determinants relate to different symptom patterns and trajectories would help identify intervention points to reduce the impact of social conditions on recovery. Consequently, this study seeks to deepen understanding of PICS, provide evidence for intervention design, and contribute to improving long-term outcomes and quality of life for ICU survivors, while also reinforcing efforts to optimize post-ICU care and attention to the sequelae of critical illness.

Chile is a particularly relevant setting for studying SDH and PICS, as marked disparities in health outcomes between social groups persist despite reforms aimed at reducing inequalities. Fragmentation of the healthcare system between the public and private sectors, together with high levels of socioeconomic inequality, could significantly influence recovery after ICU hospitalization. Inequalities translate into psychosocial factors, such as chronic stress and social support, that reflect individuals' social position within society.

This study examines the role of social determinants of health in post-ICU syndrome (PICS) symptoms, symptom profiles, and health outcomes among critically ill survivors. It also aims to (1) determine the prevalence of overall PICS, physical, cognitive, and mental health symptoms at all four data collection times, and associated risk factors; and (2) identify latent profiles of PICS symptoms and whether psychosocial determinants are associated with membership in these profiles.

To address the study aim, it will conduct a multicenter, prospective observational cohort study of 400 survivors, followed up to 12 months post-discharge from the ICU. It will recruit eligible patients from five hospitals in Chile.

It will evaluate physical, cognitive, and mental health impairment. It will also evaluate quality of life related to health, frailty, fatigue, chronic pain, and sleep impairment. Social Determinants of Health will be evaluated using different measures: social position, household socioeconomic status, chronic stress, perceived stress, social support, loneliness, and sociodemographic and previous health conditions.

It is expected to recruit 400 patients over the 4-year study period.

Keywords
Post-Intensive Care syndrome, Intensive Care unit, Critical illness, Survivorship, Social determinants of health, Health equity, Health disparity
Medical subject headings
postintensive care syndrome, Critical Illness

What is being measured

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

  1. Cognition status post-ICU

    The MOCA instrument will be administered to patients. The total possible score is 22 points; a score of 18 or above is considered normal

    Measured: From enrolment to the third, sixth, and twelfth months post-discharge from ICU

  2. Anxiety post ICU

    This mental health condition will be evaluated in patients with the HADS total scores for anxiety ranging from 0 to 21, categorized as: normal (0-7), mild (8-10), moderate (11-14), or severe (15-21).

    Measured: From enrollment to the third, sixth, and twelfth months post-discharge from ICU

  3. Depressive symptoms post-ICU

    This mental health condition will be evaluated in patients with HADS total depression scores ranging from 0 to 21, categorized as: normal (0-7), mild (8-10), moderate (11-14), or severe (15-21).

    Measured: From enrollment to the third, sixth, and twelfth months post-discharge from ICU

  4. Functional independence post-ICU

    Barthel will be used in patients; scores are ordered as follows: 0-20 total dependence, 21-60 severe dependence, 61-90 moderate dependence, 91-99 slight dependence, and 100 independence.

    Measured: From enrollment to the third, sixth, and twelfth months post-discharge from ICU

Secondary outcomes (5)
  1. Health-related quality of life, measured with the EuroQol 5-Dimension 3-Level questionnaire (EQ-5D-3L) index value

    EQ-5D is one of the most widely used health state descriptive systems and is used for valuation in Chile. EQ-5D questionnaires have 5 dimensions: "Mobility", "Human Autonomy", "Current Activities", "Pain / Discomfort", and "Anxiety / Depression," and all dimensions are described by 3 problem levels corresponding to patient response choices. A quality-of-life score is calculated based on the questionnaire responses.

    Measured: From the enrolment to 3, 6, and 12 months post-discharge from the ICU

  2. Visual Analog Scale

    The EuroQol Visual Analog Scale, part of the EQ-5D instrument, records the participant's self-rated overall health on the day of assessment, as a measure of health-related quality of life. Participants mark their health on a vertical scale ranging from 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"); higher scores indicate better self-rated health (better outcome).

    Measured: From the enrolment to 3, 6, and 12 months post-discharge from the ICU

  3. Clinical Frailty Scale (CFS)

    The Clinical Frailty Scale is a clinical judgment-based frailty tool that evaluates specific domains, including comorbidity, function, and cognition. Scores range from 1 (very fit) to 9 (terminally ill); higher scores indicate greater frailty (worse outcomes). The CFS is recommended in Chile to assess frailty in older adults admitted to the ICU.

    Measured: 3, 6, and 12 months after the ICU discharge.

  4. Pittsburgh Sleep Quality Index (PSQI).

    The Pittsburgh Sleep Quality Index is a self-report questionnaire that assesses sleep quality over the past month. Its 19 items generate seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction), each ranging from 0 to 3. The sum of the seven components yields a global score ranging from 0 to 21; higher scores indicate worse sleep quality (worse outcome). A global score greater than 5 indicates poor sleep quality.

    Measured: 3, 6, and 12 months after ICU discharge.

  5. The fatigue assessment scale

    The Fatigue Assessment Scale is a 10-item self-report questionnaire that assesses physical and mental fatigue. Each item is rated on a 5-point scale from 1 ("never") to 5 ("always"), and the total score ranges from 10 to 50; higher scores indicate greater fatigue (worse outcome). Scores of 10-21 indicate no fatigue, and scores of 22-50 indicate substantial fatigue.

    Measured: 3, 6, and 12 months after ICU discharge.

Timeline

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

  1. First posted18 Sep 2026
  2. Study start15 Sep 2025
  3. Primary completion31 Mar 2029 (estimated)
  4. Study completion31 Mar 2029 (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
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07828301
Sponsor's protocol ID
230616016
Other IDs
1241769
Status last verified
Sep 2026
First submitted
14 Sep 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Post-Intensive Care Syndrome (PICS), run by Pontificia Universidad Catolica de Chile at 5 sites in Chile.

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 7 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 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Chile. 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 Paula B Repetto, PhD (+56223549024, prepetto@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognition status post-ICU (time frame: From enrolment to the third, sixth, and twelfth months post-discharge from ICU). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 1 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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