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ICU HospitalizationNCT07117396

Chronic Pain After Intensive Care Unit: Clinical Predictors

An observational study of ICU Hospitalization and Chronic Pain, run by Attikon Hospital at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Thanks to medical advances, more patients now survive their stay in the Intensive Care Unit (ICU). However, many people who leave the ICU face long-term health problems, known as Post-Intensive Care Syndrome (PICS). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ICU Hospitalization, Chronic Pain
How many people
92 participants
Where
1 siteGreece
Study dates
11 Oct 2024to 1 Jun 2025
How long will I take part?
3 Months
Phase
Observational
Are there results?
None posted in the registry

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: Both medical and surgical patients. All eligible individuals assessed at three distinct timepoints: upon ICU admission, at ICU discharge, and three months following ICU discharge.

Who may be able to join

  • Age greater than 18 years old and
  • A minimum of one day of intensive care unit (ICU) hospitalization

Who cannot join

  • Age less than 18 years old

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • Attikon University Hospital

    Athens, Attica, 12462

Other trials in Greece

About this study

Official title: Clinical and Laboratory Predictors of Chronic Pain After Critical Illness: A Prospective Analysis of Intensive Care Unit Survivors

Thanks to medical advances, more patients now survive their stay in the Intensive Care Unit (ICU). However, many people who leave the ICU face long-term health problems, known as Post-Intensive Care Syndrome (PICS). This can include physical weakness, memory or thinking problems, anxiety or depression - and chronic pain.

Chronic pain is pain that lasts more than 12 weeks and can interfere with your daily life. Studies show that many ICU survivors still experience moderate to severe pain even a year after they go home, especially in the shoulders. This pain is often linked to conditions like severe infections or older age, but it's not yet fully understood.

Read more

To help improve care, researchers at Attikon University Hospital in Athens are studying ICU survivors to learn:

How common chronic pain is

Where it appears in the body

How severe it is

How it affects everyday activities

They are also looking at health history, treatments received in the ICU, and lab results to see if any of these are linked to pain after discharge.

If you or your loved one has been in the ICU and experiences ongoing pain, know that you're not alone - and that researchers and doctors are working to better understand and manage this problem.

Read the detailed description

Over the past two decades, improved intensive care practices have significantly reduced in-hospital mortality. However, a growing number of survivors experience a range of long-term complications, collectively known as Post-Intensive Care Syndrome (PICS). A key but underexplored component of PICS is chronic pain, defined as persistent pain lasting beyond 12 weeks or beyond the expected healing time following trauma or surgery.

Existing data suggest that up to 73% of ICU survivors report moderate to severe pain one year after discharge, with the shoulder being the most commonly affected anatomical region. Retrospective studies estimate the prevalence of chronic pain among ICU survivors to be as high as 44%. Identified risk factors include advanced age and severe sepsis; however, there is limited evidence regarding the true impact of chronic pain on activities of daily living (ADLs), its intensity, and clinical predictors.

This prospective observational study is conducted at the Intensive Care Unit of Attikon General University Hospital in Athens, Greece, and includes both medical and surgical ICU patients, including cardiothoracic surgery cases. The aim is to assess the prevalence, anatomical distribution, and intensity of chronic pain in ICU survivors, examine its interference with daily functioning, and explore associations between chronic pain and clinical or laboratory data collected during ICU admission, hospitalization, and discharge.

Patients are evaluated at three timepoints: ICU admission, ICU discharge, and three months post-ICU discharge. The inclusion criteria are age ≥18 years and ICU stay of at least 24 hours.

Detailed data collection includes:

Demographics and Lifestyle: Age, sex, educational level, occupation, weight, height, Body Mass Index (BMI), weekly physical activity.

Pain History and Characteristics: Prior history of chronic or acute pain, anatomical localization, intensity with Visual Analogue Scale score (VAS score), and pain qualities assessed using the validated Greek version of the Short-Form McGill Pain Questionnaire.

Medical History: Hypertension, dyslipidemia, arrhythmias, coronary artery disease, Chronic Obstructive Pulmonary Disease (COPD), Asthma, Obstructive Sleep Apnoea (OSA), chronic kidney disease, Gastro Esophageal Reflux Disease (GERD), peptic ulcer, thyroid disorders, diabetes, stroke, migraine, epilepsy, musculoskeletal/rheumatologic conditions, psychiatric disorders, surgical history, and opioid use.

ICU Parameters: Duration of stay, use of vasopressors, sedatives, opioids, presence of sepsis, mechanical ventilation,Acure Respiratory Distress Syndrome (ARDS), surgical procedures, and regional anesthesia.

Laboratory Data at ICU Admission and Discharge: Hematocrit, hemoglobin, White Blood Cell count (WBC), platelets, International Normalized Ratio (INR), C-reactive protein (CRP) ,fibrinogen, procalcitonin, creatinine, urea, potential of hydrogen (pH), Partial pressure of carbon dioxide (pCO₂), Partial pressure of oxygen (pO₂), Bicarbonate (HCO₃-), potassium, sodium, calcium, phosphorus, magnesium, chloride, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Gamma-Glutamyl Transferase (GGT), Alkaline Phosphatase (ALP), total bilirubin, albumin, and Thyroid-Stimulating Hormone (TSH).

The study's overarching goal is to better characterize the burden of chronic pain among ICU survivors and to inform the development of targeted preventive and therapeutic strategies. Ethical approval has been granted by the Institutional Ethics Committee of Attikon University Hospital, and all participants provide written informed consent.

Keywords
ICU Hospitalization, Chronic pain, Predictors
Medical subject headings
Chronic Pain

What is being measured

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

  1. Chronic pain

    Assement of chronic pain via questionnaire (Short-form McGill Pain Questionnaire)

    Measured: three months post discharge

Timeline

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

  1. First posted12 Aug 2025
  2. Study start11 Oct 2024
  3. Primary completion1 Jun 2025
  4. Study completion1 Jun 2025

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
92 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07117396
Sponsor's protocol ID
AttikonH 09.10.2024
Status last verified
Aug 2025
First submitted
5 Aug 2025
Last updated
14 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of ICU Hospitalization and Chronic Pain, run by Attikon Hospital at 1 site in Greece.

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 1 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: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chronic pain (time frame: three months post discharge). 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 14 Aug 2025.

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