Prediction of Functional Outcomes From Chronic Critical Illness

Status:	Recruiting
Conditions:	Hospital
Therapuetic Areas:	Other
Healthy:	No
Age Range:	18 - Any
Updated:	7/13/2018
Start Date:	April 17, 2017
End Date:	December 2022
Contact:	Summer Choudhury, MPH
Email:	summer_choudhury@med.unc.edu
Phone:	919-966-2531

The purpose of the study is to establish clinical determinants of poor cognitive and physical
functional outcome of CCI patients so that the investigators may develop and validate a
multi-dimensional clinical prediction model to more effectively inform decision making
earlier in the course of the ICU care. The investigators hypothesize that multiple premorbid
and acute factors measured early in the course of CCI will have strong independent
associations with functional recovery. The investigators further hypothesize that social and
economic factors are associated with long-term functional outcomes independent of the acute
clinical problems.

A substantial number of critically ill patients experience persistent organ failure leading
to chronic critical illness (CCI). The majority of these patients die within a year, and many
survivors must cope with long-term physical and cognitive limitations that are often severe.
Survival with severe physical and cognitive dysfunction is a significant clinical, emotional,
and economic burden in this population, but little is known about which patients are at
highest risk for physical and cognitive dysfunction. Moreover, although long-term mortality
in CCI can be reliably estimated with a validated mortality prediction model, there is
currently no validated method to predict long-term functional disability for purposes of
shared decision-making and resource planning. In order to address these gaps in knowledge,
the investigators will conduct a multi-center prospective cohort study that measures clinical
and premorbid risk factors for long-term physical and cognitive dysfunction in CCI. Using
these risk factors, the investigators will construct a multi-outcome prognostic model for
survival with severe physical or cognitive dysfunction to facilitate shared decision-making
and resource planning. Additionally, the investigators will identify independent social and
economic variables that are risk factors for long-term survival and functional disability.

Inclusion Criteria

1. Patients in enrolling ICU

2. Expected to require 7 days of mechanical ventilation uninterrupted for 72 hours for
acute illness.

3. Adults >/= 18yo of age.

Exclusion Criteria

1. Patients with respiratory failure due to neuromuscular disease

2. Patients with respiratory failure due to severe burn

3. Patients requiring chronic mechanical ventilation at home

4. Patients receiving mechanical ventilation at an outside hospital >7 days

5. Expected death prior to day 8 of mechanical ventilation therapies in 24 hrs.

6. Prisoners

7. No family member or surrogate available

8. Patient not proficient in English

9. Unwilling or unable to provide written informed consent (patient or when indicated, by
surrogate)

10. Co-enrollment in another study not approved

We found this trial at

sites

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

(919) 962-2211