Prediction of Functional Outcomes From Chronic Critical Illness

University of North Carolina (UNC)

Status: Completed

Conditions: Chronic Critical Illness; Prolonged Mechanical Ventilation

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03159208

16-0998

R01NR016459 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 589 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 (or Spanish at select sites)
9. Unwilling or unable to provide written informed consent (patient or when indicated, by surrogate)
10. Co-enrollment in another study not approved