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Targeted Exercise Intervention to Reduce Morbidity and Mortality in Sepsis

NCT04938531 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-06-24

No results posted yet for this study

Summary

This is a single arm, pilot study. Patients in the LHSC adult ICU (Critical Care Trauma Centre) (1200 patients/annum) are screened daily for severe sepsis by the Clinical Research Assistants. Severe sepsis is defined as infection, systemic inflammation and sepsis-induced dysfunction of at least one organ system. Study consent is obtained from the patient or substitute decision maker.

Our objective in this pilot study is to determine the feasibility of delivering a regular passive exercise intervention, and collecting relevant outcome data early in the course of severe sepsis in critically ill patients.

We hypothesize that early passive exercise in septic patients will reduce inflammation, endothelial cell injury, microvascular hypoperfusion and mortality. Our goal is to provide the evidence from comprehensive analysis of biochemical, physiologic and patient outcomes to develop a definitive multi-centre clinical trial.

Conditions

  • Severe Sepsis

Interventions

OTHER

Exercise

Participants will perform an entry passive exercise test within 48 hours of onset of severe sepsis. Patients then will perform 30-60 min supine passive cycle ergometry exercise 5 days/week.

Sponsors & Collaborators

  • Schulich School of Medicine and Dentistry

    collaborator UNKNOWN

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Ian Ball, MD, FRCPC · London Health Sciences Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-25
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04938531 on ClinicalTrials.gov