Targeted Exercise Intervention to Reduce Morbidity and Mortality in Sepsis

NCT04938531 | Completed

• 1 other identifier: 105319
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sepsis; Exercise; Intervention

Outcome Measures

Primary Outcomes (2)

• The proportion of prescribed exercise sessions completed by each participant

  proportion of prescribed exercise sessions completed by each participant

  28 days

• The proportion of successfully completed measurements for each patient.

  Proportion of measurements completed

  28 days

Secondary Outcomes (3)

• Inflammatory mediator levels

  28 days

• MCAv

  60 minutes

• Cardiac function

  60 minutes

Study Arms (1)

Exercise

EXPERIMENTAL

Exercise, passive

Other: Exercise

Interventions

Exercise OTHER

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.

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe sepsis defined as:
• of 4 Systemic Inflammatory Response Syndrome criteria,
• a confirmed or clinically suspected source of infection and,
• two or more organ dysfunction (using standard definitions).

You may not qualify if:

• Greater than 48h since severe sepsis criteria were met
• inability to perform passive exercise using bedside leg cycle,
• major limitation in neurologic or physical function prior to onset of severe sepsis (e.g. wheelchair or nursing home dependent),
• patients receiving neuromuscular blocking drugs or sedation targeted to a MAAS score less than 3,
• allergies to sulfonamide drugs or iodides due to possibility of an allergic reaction to ICG.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Schulich School of Medicine and Dentistry: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Related Publications (5)

• Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Aug 29;369(9):840-51. doi: 10.1056/NEJMra1208623. No abstract available.

  PMID: 23984731 BACKGROUND

• Denehy L, Skinner EH, Edbrooke L, Haines K, Warrillow S, Hawthorne G, Gough K, Hoorn SV, Morris ME, Berney S. Exercise rehabilitation for patients with critical illness: a randomized controlled trial with 12 months of follow-up. Crit Care. 2013 Jul 24;17(4):R156. doi: 10.1186/cc12835.

  PMID: 23883525 BACKGROUND

• Adler J, Malone D. Early mobilization in the intensive care unit: a systematic review. Cardiopulm Phys Ther J. 2012 Mar;23(1):5-13.

  PMID: 22807649 BACKGROUND

• Parker A, Sricharoenchai T, Needham DM. Early Rehabilitation in the Intensive Care Unit: Preventing Physical and Mental Health Impairments. Curr Phys Med Rehabil Rep. 2013 Dec;1(4):307-314. doi: 10.1007/s40141-013-0027-9.

  PMID: 24436844 BACKGROUND

• Sricharoenchai T, Parker AM, Zanni JM, Nelliot A, Dinglas VD, Needham DM. Safety of physical therapy interventions in critically ill patients: a single-center prospective evaluation of 1110 intensive care unit admissions. J Crit Care. 2014 Jun;29(3):395-400. doi: 10.1016/j.jcrc.2013.12.012. Epub 2013 Dec 30.

  PMID: 24508202 BACKGROUND

MeSH Terms

Conditions

Sepsis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ian Ball, MD, FRCPC

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: June 24, 2021
• Study Start: February 25, 2015
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: June 24, 2021

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)