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.
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.
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.
- Conditions
- ICU Hospitalization, Chronic Pain
- 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.
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.
- First posted12 Aug 2025
- Study start11 Oct 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU HospitalizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milionis Orestis, Attikon Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Laboratory Predictors of Chronic Pain After Critical Illness: A Prospective Analysis of Intensive Care Unit Survivors
- ClinicalTrials.gov ID
- NCT07117396
- Acronym / sponsor ID
- AttikonH 09.10.2024
- Conditions
- ICU Hospitalization, Chronic Pain
- Keywords
- ICU Hospitalization, Chronic pain, Predictors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Age greater than 18 years old and
- A minimum of one day of intensive care unit (ICU) hospitalization
Key exclusion criteria (1 listed)
- Age less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chronic pain
Time frame: three months post discharge
Assement of chronic pain via questionnaire (Short-form McGill Pain Questionnaire)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.