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Patients With Long-stay at ICU: Factors and Evaluation - Feasibility Study

Key facts

Who runs it
Uppsala University
Where
Sweden4 sites in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
People taking part
300 people, planned
Started
Oct 2026
Expected to end
Oct 2028
Type of study
Observational, 3 groups
Record updated
1 October 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • ICU stay of more than 4 days (96 hours) in a participating general intensive care unit (ICU)
  • Age 18 years or older
  • The first full 4 days of the current episode of intensive care were delivered at one or more participating ICUs. Patients transferred in from a non-study ICU during the first 4 days are not eligible
  • No formal decision to withdraw life sustaining treatment taken before 4 days of ICU care
  • Consent according to the two step procedure of the study, that is written informed consent from the patient, or, when the patient lacks decision making capacity at inclusion, consultation with the next of kin followed by written informed consent from the patient once decision making capacity is regained
  • The next of kin, identified as primary contact in the medical record or by the patient's choice, does not object to the patient's inclusion
  • When no next of kin or legal representative can be identified despite documented attempts before 6 days of ICU care have elapsed, the patient may be included without prior consultation, and written informed consent is sought once decision making capacity is regained
  • Age 18 years or older
  • Designated next of kin of an included patient, preferably the next of kin most involved in the patient's care in the ICU, or another person in line with the wishes of the patient and next of kin
  • Written informed consent, obtained during the ICU stay or, when needed, at the six month follow-up

Who cannot take part

  • 6 days (144 hours) or more since ICU admission at the time of inclusion
  • The patient in any form expresses unwillingness to take part
  • The patient died before the designated next of kin was included
  • Unable to complete the questionnaires in Swedish

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Every year, many critically ill patients are admitted to an intensive care unit (ICU). Most stay only a few days, but a smaller group stays much longer. In Sweden, patients treated in the ICU for more than 10 days account for about 35 percent of all ICU days. Little is known about why some patients need prolonged intensive care, or how their lives are affected afterwards.

Read full original descriptionShow less

LIFE-ICU is a planned national observational cohort study of adult patients in general intensive care. This record covers the feasibility study that precedes the main study, including its pilot part.

The feasibility study does not change the care patients receive. About 200 adult patients who have been treated in a general ICU for more than four days will be included consecutively at the participating ICUs. For each patient, a designated next of kin, usually the family member or friend most involved during the ICU stay, is invited to take part. Information is collected from the medical record about health before admission and about the ICU stay, for example organ support, delirium, nutrition and mobilisation. At ICU discharge, patients answer four questions about distressing memories from the ICU.

Six months after final discharge from intensive care, patients are contacted by letter and then by telephone. They answer questions about health status, quality of life, anxiety and depression, post-traumatic stress, fatigue, life satisfaction, frailty, overall function and occupational status. Designated next of kin answer questions about their own life satisfaction, post-traumatic stress and caregiver burden, provided that the patient is alive at the time of follow-up. A selection of patients and next of kin are also invited to an interview about their experiences of intensive care and of recovery. Staff who collect the data answer an anonymous questionnaire about how the data collection worked.

The study compares patients whose total ICU stay is more than 10 days with patients whose stay is more than 4 days and at most 10 days.

The main purpose of the feasibility study is to find out whether the planned data collection works in practice. This is assessed against criteria set in advance: how many of the eligible patients can actually be included, how complete the collected data are, and how many patients and next of kin respond at six months. The pilot part also provides the estimates needed to plan the main study, such as the proportion of patients who stay in the ICU for more than 10 days and how the measured factors are distributed.

Hypothesis: the feasibility study tests the hypothesis that the planned data collection is feasible within routine intensive care and yields data of sufficient completeness and quality to inform the design of the main study. The main study is designed to test the hypothesis that factors present before ICU admission and during the first days of intensive care contribute to a prolonged ICU stay, that some of these factors can be modified, and that they are also associated with worse long-term outcome. The feasibility study is not powered to test this hypothesis.

The long-term goal is better knowledge about prolonged intensive care, so that prognostic information can become more accurate, care can be planned more individually, and patients and next of kin can receive better support during and after the ICU stay.

The 3 groups in the trial

  • Intermediate ICU stay (more than 4 to 10 days)

    Adult patients included after more than 4 days (96 hours) of care in a participating general ICU whose total ICU length of stay is more than 4 days (\>96 hours) and at most 10 days (≤240 hours). Total ICU length of stay comprises all consecutive ICU care within the same continuous episode of critical illness, including care at non-study ICUs after transfer. Group assignment is made at final ICU discharge within the episode, irrespective of vital status at discharge.

  • Prolonged ICU stay (more than 10 days)

    Adult patients included after more than 4 days (96 hours) of care in a participating general ICU whose total ICU length of stay is more than 10 days (\>240 hours). Total ICU length of stay comprises all consecutive ICU care within the same continuous episode of critical illness, including care at non-study ICUs after transfer. Group assignment is made at final ICU discharge within the episode, irrespective of vital status at discharge.

  • Designated next of kin

    Adults taking part in their own right as designated next of kin of patients included in either patient cohort, preferably the next of kin most involved in the patient's care in the ICU. The designated next of kin is identified and approached during the ICU stay, and written informed consent is obtained during the ICU stay or, when needed, at the six month follow-up. Participation requires ability to complete the questionnaires in Swedish. Six months after the patient's final ICU discharge, designated next of kin complete questionnaires on life satisfaction, post-traumatic stress and caregiver burden, provided that the patient is alive at the time of follow-up. A strategic selection is invited to a semi structured interview. When the patient has died, no questionnaires are sent.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Patients With Long-stay at ICU: Factors and Evaluation (LIFE-ICU) - A Feasibility Study for a National Prospective Cohort Study
Record updated
1 October 2026