REVIVe: Frailty, Rehabilitation, and Outcomes in Critically Ill Adult and Pediatric Survivors of COVID-19 or ARI

NCT ID: NCT05246098

Last Updated: 2024-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-24

Study Completion Date

2025-10-01

Brief Summary

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Background: Many adults and some children with COVID-19 or acute respiratory infection become critically ill and need advanced life support in the Intensive Care Unit (ICU). Frailty is a medical condition of reduced function and health. Adults with frailty have a lower chance of surviving critical illness. The investigators are still learning about critically ill adults with COVID-19 or acute respiratory infection, and do not have much information on how frailty affects outcomes in critically ill children, with or without COVID-19 or acute respiratory infection. Rehabilitation can help survivors of COVID-19 or acute respiratory infection by improving strength and improve quality of life (QOL).

Objectives: The main goal of this research study is to see if patients with frailty have a lower chance of surviving COVID-19 or acute respiratory infection critical illness and more health problems after survival than patients without frailty. The investigators will also study the types of rehabilitation received by patients with COVID-19 or acute respiratory infection.

Methods: The investigators will include adults and children with COVID-19 or acute respiratory infection who are admitted to the ICUs that participate in the study. The investigators will gather data about each patient, including before and during their illness.

Outcomes: The investigators will collect level of frailty, function, and types of therapy, or rehabilitation received by patients. In adults, the investigators are most interested in learning if frailty influences mortality, or death. In children, the investigators are most interested in whether children with COVID-19 or acute respiratory infection critical illness are more likely to develop frailty. The investigators will also study post-hospital discharge location in survivors (e.g., home, rehabilitation).

Relevance: The COVID-19 pandemic is a global public health crisis. It is critical to understand how COVID-19 and other acute respiratory infection critical illness affects groups of people who are at higher risk, and the impact on outcomes that are important to patients, like functioning and QOL. The results will help policy makers plan post-hospital services for survivors, help healthcare workers understand the importance of rehabilitation practice for patients with COVID-19 or acute respiratory infection, and help researchers develop treatments to improve QOL after COVID-19 or acute respiratory infection.

Detailed Description

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Conditions

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Respiratory Disease COVID-19 Viral Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Adults

Adult survivors of COVID-19 or acute respiratory infection admitted to participating ICUs. Adults are defined as greater than or equal to, 18 years old. We will include adults with a confirmed diagnosis of COVID-19 or those with suspected or proven acute respiratory infection with onset within 14 days of ICU admission and requiring invasive mechanical ventilation, non-invasive ventilation, or high-flow oxygen therapy.

No interventions assigned to this group

Pediatrics

Pediatric survivors of COVID-19, MIS-C, or acute respiratory infection admitted to participating pediatric intensive care units (PICUs). The investigators define children as less than 18 years old. We will include pediatric patients with COVID-19, those with multi-system inflammatory syndrome in children (MIS-C), and those with suspected or proven acute respiratory infection with onset within 14 days of ICU admission and requiring invasive mechanical ventilation, non-invasive ventilation, or high-flow oxygen therapy.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult and pediatric survivors of COVID-19 or acute respiratory infection admitted to participating intensive care units (ICUs) and PICUs. The investigators define children as less than, and adults as greater than or equal to, 18 years old, respectively. The investigators will include adults and pediatrics with a confirmed diagnosis of COVID-19, pediatric patients with MIS-C, and adults and pediatrics with suspected or proven acute respiratory infection with onset within 14 days of ICU/PICU admission and requiring invasive mechanical ventilation, non-invasive ventilation, or high flow oxygen therapy.

Exclusion Criteria

* Patients who were admitted to ICU for \<24 hours
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Canadian Critical Care Trials Group

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle E Kho, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status ACTIVE_NOT_RECRUITING

University of Alberta

Edmonton, Alberta, Canada

Site Status RECRUITING

Sturgeon Community Hopsital

St. Albert, Alberta, Canada

Site Status NOT_YET_RECRUITING

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Site Status NOT_YET_RECRUITING

Children's Hospital of Winnipeg

Winnipeg, Manitoba, Canada

Site Status ACTIVE_NOT_RECRUITING

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status RECRUITING

Izaak Walton Killam Hospital for Children

Halifax, Nova Scotia, Canada

Site Status RECRUITING

Brantford General Hospital

Brantford, Ontario, Canada

Site Status RECRUITING

Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status RECRUITING

St. Joseph's Healthcare Intensive Care Unit

Hamilton, Ontario, Canada

Site Status RECRUITING

McMaster Children's Hospital

Hamilton, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Juravinski Hospital

Hamilton, Ontario, Canada

Site Status RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Site Status RECRUITING

London Health Sciences Centre

London, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status RECRUITING

Niagara Health System

St. Catharines, Ontario, Canada

Site Status RECRUITING

Sunnybrook Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Hôpital Hôtel-Dieu de Lévis

Lévis, Quebec, Canada

Site Status RECRUITING

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Site Status RECRUITING

The Centre hospitalier universitaire Sainte-Justine

Montreal, Quebec, Canada

Site Status NOT_YET_RECRUITING

Montreal Children's Hospital

Montreal, Quebec, Canada

Site Status ACTIVE_NOT_RECRUITING

Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, Canada

Site Status RECRUITING

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, Canada

Site Status RECRUITING

Hôpital Fleurimont - Sherbrooke

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Saskatchewan Health Authority

Regina, Saskatchewan, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Geoff Strong, PT, MS

Role: CONTACT

905-522-1155 ext. 33242

Facility Contacts

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Oleksa Rewa, MD, MSc

Role: primary

780.231.3280

Jocelyn Slemko, MD, MSc

Role: primary

xxxxxxxxxx

Steven Reynolds, MD

Role: primary

xxxxxxxxxx

Volker Eichhorn, MD, MBA

Role: primary

9024733486

Jennifer Foster, MD

Role: primary

9024707515

Brenda Reeve

Role: primary

Maureen Meade

Role: primary

Michelle Kho, PT, PhD

Role: primary

Bram Rochwerg

Role: primary

John Muscedere

Role: primary

Andrew Seely

Role: primary

Jennifer Tsang

Role: primary

Rob Fowler

Role: primary

Karen Burns

Role: primary

Patrick Archambault

Role: primary

Han Ting Wang

Role: primary

Laurence Ducharme-Crevier, MD, MSc

Role: primary

5143454931

Karim Serri

Role: primary

Patricia Lizotte

Role: primary

Frederick D'Aragon

Role: primary

Eric Sy

Role: primary

Other Identifiers

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REVIVe

Identifier Type: -

Identifier Source: org_study_id

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