Efficacy and Safety of a Multicomponent Physical Therapy Program in Mechanically Ventilated Patient With Sepsis

NCT03406494 | Unknown DMC

• 1 other identifier: LC2016PY036
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

Despite of a remarkable decrease in overall mortality has been achieved following the International Guidelines for Management of Sepsis and Septic Shock since 2004,the short-and long-term outcomes remain poor in critically ill sepsis patients who had experienced prolonged ventilation in the Intensive Care Unit (ICU). The reason could be due to some subsequent complications developed in the ICU rather than original disease, e.g., ICU-acquired weakness (ICUAW), delirium, diaphragmatic dysfunction (DD) and acute gastrointestinal (GI) injury, which are still not fully recognized or dealt with in a majority of ICU settings across China. This study is aimed to examine whether a multi-component physical therapy (PT) program against these lethal ICU-related complications could reduce ICU 28-day mortality, improve independent functional status and 1-year survival in this subset of patients.

Conditions

Sepsis

Keywords

sepsis; critical illness; intensive care unit; mechanical ventilation; rehabilitation; mortality; physical function; health-related quality of life

Outcome Measures

Primary Outcomes (1)

• ICU 28-day mortality

  Sepsis or non-sepsis related death, undetermined cause of death.

  Through 28-day study period in the ICU.

Secondary Outcomes (10)

• Incidence of ICU-required weakness

  Assessed on the day of recruitment, repeated on the days of first try to wean from ventilator, ICU discharge and hospital discharge, with an average of 1 month.

• Incidence of delirium

  Assessed on the day of recruitment, repeated on the days of first try to wean from ventilator, ICU discharge and hospital discharge, with an average of 1 month.

• Incidence of diaphragmatic dysfunction

  Assessed on the day of first try to wean from ventilator, repeated on the days of ICU discharge and hospital discharge, with an average of 1 month.

• Incidence of acute gastrointestinal injury

  Assessed on the day of recruitment, repeated on the days of first try to wean from ventilator, ICU discharge and hospital discharge, with an average of 1 month.

• Ventilator dependence

  Number of days required to weaning after the first try, number of days on ventilator, assessed within an average of 3 weeks.

Study Arms (2)

intervention group

EXPERIMENTAL

Early multicomponent physical therapy program plus sepsis standard therapy

Other: Early multicomponent physical therapy program

control group

NO INTERVENTION

Sepsis standard therapy, including early initiation of intravenous antibiotics, infection source debriding, appropriate fluid therapy, minimum sedation, protocolized weaning procedure, blood glucose control and early enteral feeding, etc.

Interventions

Early multicomponent physical therapy program OTHER

1. Positioning (upright bed standing; turning, moving on bed). 2. Peripheral muscle strength training (active or passive full range of motion, lower extremities ergometer cycling). 3. Respiratory muscle training (supine abdominal breathing training). 4. Neuromuscular electrical stimulation (NMES) on target muscles (bilateral bicipital muscles, quadriceps femoris muscles and rectus femoris). 5. Gut rehabilitation (midfrequency NMES; abdominal manual or vibration massage).

intervention group

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with sepsis in accordance with the Sepsis-3 Criteria.
• ≤ age ≤ 75 years.
• Mechanically ventilated for less than 72 hours at recruitment and expected to continue for at least 3 days.
• Ability to obtain informed consent from patient or proxy.

You may not qualify if:

• acute central nervous system disease (e.g. severe cerebral injury, acute cerebral hemorrhage, brain infarction).
• active neuromuscular diseases that limiting patient to physical training (e.g. amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis, polymyositis, muscular dystrophy).
• severe thoracic or abdominal trauma.
• acute myocardial infarction, severe arrhythmia, acute heart failure, hemo-dynamic instability or shock.
• drug abuse, alcohol addiction, opiates or other drug dependence and psychiatric disorder history.
• known pregnancy.
• malignant tumor, cachexia, end stage of chronic illness.
• contraindications to rehabilitation therapy.
• inability to obtain an informed consent from patient or a proxy.
• any other factors such as fractures or limb malformation, that would prevent response to physical exercise or cause injury to the patient.

Sponsors & Collaborators

• Zhujiang Hospital: lead
• Southern Medical University, China: collaborator

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MeSH Terms

Conditions

Sepsis; Critical Illness

Condition Hierarchy (Ancestors)

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

Study Officials

• Yan Zhang

  Zhujiang Hospital

  STUDY DIRECTOR

Central Study Contacts

Hua Wang

CONTACT

+86 18665000903; icuwanghua@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be independent from the study and blinded from patient allocations.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of Critical Care Department, Zhujiang Hospital

Model Details: prospective, multicenter, assessor-blinded, randomized controlled trial

Study Record Dates

• First Submitted: December 25, 2017
• First Posted: January 23, 2018
• Study Start: March 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: April 30, 2021
• Last Updated: January 23, 2018

Record last verified: 2018-01