NCT03940755

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

May 1, 2019

Last Update Submit

January 5, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Survival rate of ICU survivors

    Critically ill patients discharged from ICU are defined as survivors

    3 or 6 months after ICU discharge

Secondary Outcomes (7)

  • Assessment of life quality

    3 or 6 months after ICU discharge

  • Assessment in Physical dysfunction

    3 or 6 months after ICU discharge

  • Assessment in depression and anxiety

    3 or 6 months after ICU discharge

  • Assessment in PTSD

    3 or 6 months after ICU discharge

  • Assessment in Cognitive impairments

    3 or 6 months after ICU discharge

  • +2 more secondary outcomes

Study Arms (1)

Critical Illness Survivors

Those intensive care unit(ICU) patients who survive from critical illness.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ICU patients of Jiangyin people's hospital

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jiangyin People's Hospital

Jiangyin, Jiangsu, 210009, China

RECRUITING

Zhongda Hospital

Nanjing, Jiangsu, 210009, China

NOT YET RECRUITING

Related Publications (3)

  • 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.

    PMID: 24088092BACKGROUND
  • 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.

    PMID: 26728966BACKGROUND
  • 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.

    PMID: 26974547BACKGROUND

Study Officials

  • Jian-jun Yang, PhD

    Zhongda Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-jun Yang, PhD

CONTACT

Ying Li, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director,Department of Anesthesiology

Study Record Dates

First Submitted

May 1, 2019

First Posted

May 7, 2019

Study Start

June 1, 2019

Primary Completion

October 1, 2020

Study Completion

June 30, 2021

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations