Intensive Care Unit Recovery

NCT04154995 | Completed DMC

• 1 other identifier: RTPO 1055
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Survival rates of patients with critical illness have increased due to improved facilities and treatment methods in the intensive care unit (ICU). Despite surviving critical illness, patients often face a difficult road of rehabilitation after discharge from the ICU or the hospital ward. A large body of evidence indicates that critical illness survivors suffer from physical and mental health problems, reflected in a reduced health related quality of life. However, detailed studies on longer-term outcomes and physical and mental recovery are lacking. In order to develop a tailored aftercare intervention program for critical care survivors a detailed description of the specific health problems is necessary. The aim of this study is to evaluate the change in health-related quality of life (HRQoL) and physical and mental health of critical illness survivors.

Conditions

Post Intensive Care Unit Syndrome; Intensive Care Unit Acquired Weakness; Critical Illness

Keywords

Long-term recovery; Critical Illness

Outcome Measures

Primary Outcomes (1)

• Health-related Quality of Life

  Change in HRQoL using the Dutch translation of the Research and Development-36 item Health Survey (RAND-36). This survey consists of nine subscales (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health perception and health change). Total subscale scores are reported with a range of 0 to 100 percent. Higher values represent a better outcome.

  Baseline, 3, 6 and 12 months

Secondary Outcomes (19)

• Quadriceps muscle layer thickness

  Baseline, 3, 6 and 12 months

• Bioimpedance measurement in BIVA

  Baseline, 3, 6 and 12 months

• Hand grip strength

  Baseline, 3, 6 and 12 months

• Walking distance

  3, 6 and 12 months

• physical activity

  Baseline, 3, 6 and 12 months

Other Outcomes (2)

• Baseline demographic data

  Baseline, 3, 6 and 12 months

• Clinical data during ICU stay from standard care

  Retrieved at 12 months from electronic patient data file

Study Arms (1)

Long-term ICU patients

Patients with a ICU length of stay of at least 48 hours.

Diagnostic Test: Venipuncture; Diagnostic Test: Ultrasound Quadriceps Muscles

Interventions

Venipuncture DIAGNOSTIC_TEST

Blood testing at 3, 6 and 12 months

Long-term ICU patients

Ultrasound Quadriceps Muscles DIAGNOSTIC_TEST

Ultrasound measurement of quadriceps muscle mass and health

Long-term ICU patients

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

All patients admitted to the ICU with an expected stay of 48 hours or longer will be asked for consent to participation of this study. The average number of patients admitted per year to the ICU of Medical Centre Leeuwarden with a length of stay (LOS) \> 48 hours is 230. Due to practical limitations, we aim to include a maximum number of 80 patients within a six-month period. After six months, the inclusion will be stopped irrespective of the number of included patients.

You may qualify if:

• Expected length of stay ICU ≥ 48 hours

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Frisius Medisch Centrum: lead

Study Sites (1)

Medical Center Leeuwarden

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: November 7, 2019
• Study Start: May 20, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 14, 2021

Record last verified: 2021-01

Locations

NL (1)