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

NCT07851974 | Not Yet Recruiting

• 2 other identifiers: LIFE-ICU feasibility2026-02904-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

Brief Summary

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. 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.

Conditions

Frailty; Delirium Confusional State; Persistent Critical Illness; Post-Intensive Care Syndrome; Health-related Quality of Life

Keywords

Prolonged ICU stay; Long-stay ICU patients; Prospective cohort study; Patient reported outcome measures; Fatigue; ICU length of stay; Critical care; Next of kin; Family caregivers; Post intensive care syndrome, family; Health-related quality of life; Post-traumatic stress; Feasibility study

Outcome Measures

Primary Outcomes (3)

• Inclusion rate: proportion of eligible screened patients who are included

  Denominator is all patients screened during the inclusion period who fulfil the eligibility criteria other than consent and no objection, that is age, timing, ICU episode and treatment limitation. Numerator is those included. Screening is documented in a log at each site with one row per screened patient. Reasons for non-inclusion are categorised as consent requirements not met, patient objects, next of kin objects, decision to withdraw life sustaining treatment taken before eligibility, logistic reasons, and other. The proportion is reported overall and per site with a 95 percent confidence interval. Progression criteria: at least 80 percent, proceed without change. 60 to 79 percent, proceed after revision of screening and consent routines. Below 60 percent, redesign before the main study.

  From eligibility at more than 4 days of ICU care until inclusion, through the inclusion period of 12 months

• Data completeness: proportion of applicable required fields completed in the electronic case report form

  Denominator is all required fields, and conditional fields rendered applicable by branching logic, for included patients across the baseline form, the retrospective forms for ICU days 0 to 3, the daily and per shift forms from day 4 until ICU discharge, and the discharge form. Numerator is fields containing a valid value. Completeness is reported overall, per form, per data domain and by inclusion route with a 95 percent confidence interval, together with patterns of missing data and the proportion of patients with a complete record. Progression criteria: at least 95 percent, proceed without change. 85 to 94 percent, proceed after revision of the form and the data collection manual. Below 85 percent, redesign before the main study.

  From ICU admission through final ICU discharge within the episode, an estimated average of 14 days

• Six month follow-up response rate in patients and designated next of kin

  Numerator is participants who complete or return at least one follow-up instrument. Denominator for patients is all included patients alive at follow-up, including those unable to complete the questionnaires in Swedish. Denominator for designated next of kin is all identified designated next of kin who have consented and whose patient is alive at follow-up. Contact follows the predefined letter, telephone and reminder routine for each group. Rates are reported separately with 95 percent confidence intervals, together with the proportion completing all instruments, the number of contact attempts, reasons for non-response, and the number of designated next of kin who declined consent at follow-up. Progression criteria for patients: at least 75 percent, proceed. 60 to 74 percent, revise routines. Below 60 percent, redesign. Levels for designated next of kin are 10 percentage points lower.

  Six months after final ICU discharge within the episode, through the reminder period of 4 weeks

Secondary Outcomes (14)

• Timeliness of data entry into the electronic case report form

  From ICU admission through final ICU discharge within the episode, an estimated average of 14 days

• Proportion of patients with a total ICU length of stay of more than 10 days

  From ICU admission through final ICU discharge within the episode, an estimated average of 14 days

• Record linkage to the Swedish Intensive Care Registry

  At completion of follow-up, approximately 20 months after the first inclusion

• Distribution of inclusion routes

  At inclusion, within 6 days of ICU admission

• Consent outcome in patients not able to give written informed consent at inclusion

  From inclusion through six months after final ICU discharge within the episode

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients cared for in general intensive care units at participating university, county and district hospitals in Sweden, delivering mixed medical, surgical and trauma intensive care. All patients whose ICU stay exceeds 4 days are screened consecutively during the inclusion period, irrespective of admission diagnosis, so that the cohort reflects the case mix of routine Swedish general intensive care rather than a selected diagnostic group. Specialised units, that is cardiothoracic, neurointensive, burn and paediatric intensive care units, do not include patients. Designated next of kin of included patients take part in their own right, preferably the next of kin most involved in the patient's care in the ICU.

You may qualify if:

• 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
• 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

You may not qualify if:

• The patient in any form expresses unwillingness to take part
• 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
• The patient died before the designated next of kin was included
• Unable to complete the questionnaires in Swedish

Sponsors & Collaborators

• Uppsala University: lead
• Region Gävleborg: collaborator
• Region Uppsala Public Health and Care: collaborator
• Dalarna County Council, Sweden: collaborator

Study Sites (4)

Falu lasarett, Intensivvårdsavdelningen

Falun, 79182, Sweden

Location

Hudiksvalls sjukhus, Intensivvårdsavdelningen

Hudiksvall, 824 81, Sweden

Location

Mora lasarett, Intensivvårdsavdelningen

Mora, 792 85, Sweden

Location

Akademiska sjukhuset, Centrala intensivvårdsavdelningen

Uppsala, 751 85, Sweden

Location

Related Links

• Swedish Intensive Care Registry

MeSH Terms

Conditions

Frailty; Confusion; postintensive care syndrome; Fatigue

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Ing-Marie Larsson, RN, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

• Björn Ahlström, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ing-Marie Larsson, RN, PhD

CONTACT

+46 72 210 1833; ing-marie.larsson@uu.se

Björn Ahlström, MD, PhD

CONTACT

+46 23 490 131; bjorn.ahlstrom@uu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: October 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 12 months after publication of the results of the feasibility study and ending 10 years after study completion.
• Access Criteria: Data are shared with researchers upon reasonable request, after approval by the Swedish Ethical Review Authority and in accordance with the General Data Protection Regulation and Swedish legislation on public access and secrecy. A written study protocol is reviewed by the Central Steering Committee, and a data sharing agreement is established with the sponsor.

Locations

SE (4)