Clinical trial NCT03940755: Long-term Outcomes of Critical Illness Survivors
Official title: Long-term Outcomes of Critical Illness Survivors：a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intensive Care Units
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU patients of Jiangyin people's hospital

Brief summary: The goal of this study is to assess the Long-term Outcomes of Critical Illness Survivors,including physical, psychological, and cognitive sequelae.

Detailed description: An increasing number of patients survive critical illness; however, the evidence reveals that over the same period the number of patients being sent to rehabilitation settings have tripled . For those who do survive, the latest data indicate that 50-70% of ICU "survivors" will suffer cognitive impairment and 60-80% of "survivors" will suffer functional impairment or ICU-acquired weakness (ICU-AW).Still,there is a lack valid data on the long-term impact on morbidity from prospective observational studies. Therefore, the investigators designed an observational cohort which cover a broader range of outcomes to quantify long-term physical, psychological, and cognitive impairment after intensive care unit (ICU).Intensive Care Unit patients survive from critical illness will be approached for study recruitment and participation.Survival rate,Quality of life,Cognitive impairments,Depression and anxiety,PTSD,Physical activity,Neuromuscular impairment will be assessed 3 or 6 months after ICU discharge.

Eligibility criteria: Inclusion Criteria:

* Patients aged \>17 years
* Patients in intensive care unit(ICU) with at least one organ or system dysfunction,such as respiratory failure, cardiogenic shock,or septic shock.

Exclusion Criteria:

* Refuse to participate
* Death before ICU discharge
* pre-existing cognitive impairment, malignant tumor

Primary outcomes:
measure: Survival rate of ICU survivors
timeFrame: 3 or 6 months after ICU discharge
Secondary outcomes:
measure: Assessment of life quality
timeFrame: 3 or 6 months after ICU discharge
measure: Assessment in Physical dysfunction
timeFrame: 3 or 6 months after ICU discharge
measure: Assessment in depression and anxiety
timeFrame: 3 or 6 months after ICU discharge
measure: Assessment in PTSD
timeFrame: 3 or 6 months after ICU discharge
measure: Assessment in Cognitive impairments
timeFrame: 3 or 6 months after ICU discharge
measure: Patients' care and support needs;social and economical consequences
timeFrame: 3 or 6 months after ICU discharge
measure: Neuromuscular impairment
timeFrame: 3 or 6 months after ICU discharge
Other outcomes:
Locations:
city: Jiangyin
country: China
facility: Jiangyin People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Jian-jun Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.
citation: Wischmeyer PE, San-Millan I. Winning the war against ICU-acquired weakness: new innovations in nutrition and exercise physiology. Crit Care. 2015;19 Suppl 3(Suppl 3):S6. doi: 10.1186/cc14724. Epub 2015 Dec 18.
citation: McNelly AS, Rawal J, Shrikrishna D, Hopkinson NS, Moxham J, Harridge SD, Hart N, Montgomery HE, Puthucheary ZA. An Exploratory Study of Long-Term Outcome Measures in Critical Illness Survivors: Construct Validity of Physical Activity, Frailty, and Health-Related Quality of Life Measures. Crit Care Med. 2016 Jun;44(6):e362-9. doi: 10.1097/CCM.0000000000001645.