Long-term Outcomes of Critical Illness Survivors

Intensive Care Units Clinical Trial

Official title:

Long-term Outcomes of Critical Illness Survivors：a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03940755
• Other study ID #: 20190501
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: January 2020
• Source: Zhongda Hospital
• Contact: Jian-jun Yang, PhD
• Phone: 13357739238
• Email: yjyangjj[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Intensive Care Units

Locations

Country	Name	City	State
China	Jiangyin People's Hospital	Jiangyin	Jiangsu
China	Zhongda Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jian-jun Yang

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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:S6. doi: 10.1186/cc14724. Epub 2015 Dec 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate of ICU survivors	Critically ill patients discharged from ICU are defined as survivors	3 or 6 months after ICU discharge
Secondary	Assessment of life quality	Quality of Life assessed with help of The 36-item short from health survey(SF-36)questionnaire.The SF-36 has 8 scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100. Lower scores = more disability, higher scores = less disability.The 8 sections are listed below:PF:Physical Functioning,RP:Role-Physical,BP:Bodily Pain,GH:General Health,VT:Vitality,SF:Social Functioning,RE:Role-Emotional,MH:Mental Health.	3 or 6 months after ICU discharge
Secondary	Assessment in Physical dysfunction	Functional disabilities assessed with help of Barthel index of ADL(activities of daily living).10 variables are addressed. Range of summed total score: 0-100. higher values represent better outcome.	3 or 6 months after ICU discharge
Secondary	Assessment in depression and anxiety	Depression and anxiety assessed with help of The Hospital Anxiety and Depression Scale(HADS).For Depression(D), 7 questions in total. Range of score for each question: 0-3. Total score summed: 0-21 ;For Anxiety(A): 7 questions in total. Range of score for each question: 0-3. Total score summed: 0-21 .For both D and A scales, higher scores represent worse outcome.	3 or 6 months after ICU discharge
Secondary	Assessment in PTSD	Post-traumatic stress syndrome assessed with help of trauma screening questionnaire(TSQ).There are 10 questions in the TSQ. For each question, the answer is either YES or NO. More YES = worse outcome. At least 6 YES represents PTSD diagnosis.	3 or 6 months after ICU discharge
Secondary	Assessment in Cognitive impairments	Cognitive impairments assessed with help of mini-mental state examination(MMSE).The MMSE has 5 scaled scores; the scores are weighted sums of the questions in each section. The 5 sections and their range of score are listed below:Orientation 0-10;Registration 0-3;Attention and calculation 0-5;Recall 0-3;Language 0-9.Total score range from 0-30. Lower scores = more disability, higher scores = less disability.	3 or 6 months after ICU discharge
Secondary	Patients' care and support needs;social and economical consequences	Patients' information of specific needs and supports and social or economical impact post ICU.	3 or 6 months after ICU discharge
Secondary	Neuromuscular impairment	Neuromuscular impairment will be assessed by electromyography/nerve conduction study	3 or 6 months after ICU discharge