Intensive Care UnitsNCT03940755
Long-term Outcomes of Critical Illness Survivors
An observational study of Intensive Care Units, run by Jian-jun Yang at 2 sites in China.
Trial summary
The goal of this study is to assess the Long-term Outcomes of Critical Illness Survivors,including physical, psychological, and cognitive sequelae. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Units
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2019to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients of Jiangyin people's hospital
Who may be able to join
- 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.
Who cannot join
- Refuse to participate
- Death before ICU discharge
- pre-existing cognitive impairment, malignant tumor
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Jiangyin People's Hospital
Jiangyin, Jiangsu, 210009
Zhen Wu, Master, 18921233191
- Not yet recruiting
Zhongda Hospital
Nanjing, Jiangsu, 210009
Jian-jun Yang, 13357739238, yjyangjj@126.com
Mu-huo Ji, 13912975380, jimuhuo2009@sina.com
About this study
Official title: Long-term Outcomes of Critical Illness Survivors：a Prospective Cohort Study
The goal of this study is to assess the Long-term Outcomes of Critical Illness Survivors,including physical, psychological, and cognitive sequelae.
Read the 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.
- Conditions
- Intensive Care Units
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critical Illness Survivors | Those intensive care unit(ICU) patients who survive from critical illness. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate of ICU survivors
Critically ill patients discharged from ICU are defined as survivors
Measured: 3 or 6 months after ICU discharge
Secondary outcomes (7)
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.
Measured: 3 or 6 months after ICU discharge
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.
Measured: 3 or 6 months after ICU discharge
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.
Measured: 3 or 6 months after ICU discharge
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.
Measured: 3 or 6 months after ICU discharge
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.
Measured: 3 or 6 months after ICU discharge
Patients' care and support needs;social and economical consequences
Patients' information of specific needs and supports and social or economical impact post ICU.
Measured: 3 or 6 months after ICU discharge
Neuromuscular impairment
Neuromuscular impairment will be assessed by electromyography/nerve conduction study
Measured: 3 or 6 months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Jun 2019
- Primary completion1 Oct 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intensive Care UnitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jian-jun Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian-jun Yang, Zhongda Hospital
- Investigators
- Jian-jun Yang, PhD, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940755
- Sponsor's protocol ID
- 20190501
- Status last verified
- Jan 2020
- First submitted
- 1 May 2019
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24088092Wischmeyer 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.
PubMed 26728966McNelly 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.
PubMed 26974547
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Critical Illness Survivors：a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03940755
- Acronym / sponsor ID
- 20190501
- Conditions
- Intensive Care Units
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jian-jun YangUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critical Illness Survivors | – | –Those intensive care unit(ICU) patients who survive from critical illness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients of Jiangyin people's hospital
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Refuse to participate
- Death before ICU discharge
- pre-existing cognitive impairment, malignant tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival rate of ICU survivors
Time frame: 3 or 6 months after ICU discharge
Critically ill patients discharged from ICU are defined as survivors
7 secondary outcomes
Assessment of life quality
Time frame: 3 or 6 months after ICU discharge
Assessment in Physical dysfunction
Time frame: 3 or 6 months after ICU discharge
Assessment in depression and anxiety
Time frame: 3 or 6 months after ICU discharge
Assessment in PTSD
Time frame: 3 or 6 months after ICU discharge
Assessment in Cognitive impairments
Time frame: 3 or 6 months after ICU discharge
Patients' care and support needs;social and economical consequences
Time frame: 3 or 6 months after ICU discharge
Neuromuscular impairment
Time frame: 3 or 6 months after ICU discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Background: PubMed 24088092Pandharipande 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.
- Background: PubMed 26728966Wischmeyer 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.
- Background: PubMed 26974547McNelly 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian-jun Yang, PhD principal investigator
Zhongda Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Units, run by Jian-jun Yang at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian-jun Yang, PhD (13357739238, yjyangjj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate of ICU survivors (time frame: 3 or 6 months after ICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03940755, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.