Long-term Outcomes of Critical Illness Survivors

Overview

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

Full Title of Study: “Long-term Outcomes of Critical Illness Survivors:a Prospective Cohort Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 1, 2020

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.

Arms, Groups and Cohorts

  • Critical Illness Survivors
    • Those intensive care unit(ICU) patients who survive from critical illness.

Clinical Trial Outcome Measures

Primary Measures

  • Survival rate of ICU survivors
    • Time Frame: 3 or 6 months after ICU discharge
    • Critically ill patients discharged from ICU are defined as survivors

Secondary Measures

  • Assessment of life quality
    • Time Frame: 3 or 6 months after ICU discharge
    • 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.
  • Assessment in Physical dysfunction
    • Time Frame: 3 or 6 months after ICU discharge
    • 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.
  • Assessment in depression and anxiety
    • Time Frame: 3 or 6 months after ICU discharge
    • 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.
  • Assessment in PTSD
    • Time Frame: 3 or 6 months after ICU discharge
    • 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.
  • Assessment in Cognitive impairments
    • Time Frame: 3 or 6 months after ICU discharge
    • 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.
  • Patients’ care and support needs;social and economical consequences
    • Time Frame: 3 or 6 months after ICU discharge
    • Patients’ information of specific needs and supports and social or economical impact post ICU.
  • Neuromuscular impairment
    • Time Frame: 3 or 6 months after ICU discharge
    • Neuromuscular impairment will be assessed by electromyography/nerve conduction study

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jian-jun Yang
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jian-jun Yang, Director,Department of Anesthesiology – Zhongda Hospital
  • Overall Official(s)
    • Jian-jun Yang, PhD, Principal Investigator, Zhongda Hospital
  • Overall Contact(s)
    • Jian-jun Yang, PhD, 13357739238, yjyangjj@126.com

References

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.

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.

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.