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Long-term Outcomes of Critical Illness Survivors

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03940755
Enrollment
200
Registered
2019-05-07
Start date
2019-06-01
Completion date
2021-06-30
Last updated
2020-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Units

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.

Interventions

None listed

Sponsors

Jian-jun Yang
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Survival rate of ICU survivors3 or 6 months after ICU dischargeCritically ill patients discharged from ICU are defined as survivors

Secondary

MeasureTime frameDescription
Assessment in Physical dysfunction3 or 6 months after ICU dischargeFunctional 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.
Assessment in depression and anxiety3 or 6 months after ICU dischargeDepression 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.
Assessment in PTSD3 or 6 months after ICU dischargePost-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.
Assessment of life quality3 or 6 months after ICU dischargeQuality 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.
Patients' care and support needs;social and economical consequences3 or 6 months after ICU dischargePatients' information of specific needs and supports and social or economical impact post ICU.
Neuromuscular impairment3 or 6 months after ICU dischargeNeuromuscular impairment will be assessed by electromyography/nerve conduction study
Assessment in Cognitive impairments3 or 6 months after ICU dischargeCognitive 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.

Countries

China

Contacts

Primary ContactJian-jun Yang, PhD
yjyangjj@126.com13357739238
Backup ContactYing Li, MD
shushao@yeah.net15852655431

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026