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

NCT ID: NCT03406494

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-31
• Study Completion Date: 2021-04-30

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.

Detailed Description

The study is a prospective, multi-center, assessor-blinded, randomized controlled trial and will be conducted in 9 medical ICUs at 7 tertiary hospitals in Southern China. Mechanically ventilated septic patient admitted into ICU will be screened for eligibility into the study. When medically stable, patients randomize into the intervention group will receive a multi-component PT. The PT program is designed to counteract ICUAW, delirium, DD and acute GI injury, and consists of 5 consecutive sessions including positioning, extremities muscle strength training, respiratory muscle strength training, neuromuscular electrical stimulation (NMES) and gut rehabilitation. Each PT session will last for 30 minutes and be provided once daily, 5 days per week, and tailored for each individual subject. PT intervention will continue throughout patient's ICU stay or the primary endpoint is reached. The primary outcome will be the ICU 28-day all-cause mortality, and the secondary outcome measures, e.g., incidences or duration of ICUAW, delirium, DD and acute GI injury, mechanical ventilation outcomes (ventilator dependence, ventilator-free days), adverse events, restoration to independent functional status and long-term survival, will be assessed at preset time points of interviews during periods of treatment and 1-year follow-up after discharge from hospital. The total in-hospital and re-hospitalization costs in the intervention group will be also analyzed and compared to control group to assess the cost-effectiveness of the rehabilitation program.To our knowledge, this study is the first randomized controlled trial examining the efficacy and safety of a multi-component PT program in critically ill sepsis patients on ventilator. Given that rehabilitation is not a routine therapy across most ICUs in China, If this PT program is found to be of mortality benefit, it will provide an alternative non-pharmaceutical approach to deal with these lethal ICU-related complications and reduce the subsequent death. It will also provide useful information for clinical decision and local medical policies making, as well as identifying sepsis patient population who might best benefit from early rehabilitation program.

Conditions

Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

intervention group

Early multicomponent physical therapy program plus sepsis standard therapy

Group Type: EXPERIMENTAL

Early multicomponent physical therapy program

Intervention Type: 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).

control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early multicomponent physical therapy program

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 Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Diagnosed with sepsis in accordance with the Sepsis-3 Criteria.

2. 16 ≤ age ≤ 75 years.

3. Mechanically ventilated for less than 72 hours at recruitment and expected to continue for at least 3 days.

4. Ability to obtain informed consent from patient or proxy.

Exclusion Criteria

1. acute central nervous system disease (e.g. severe cerebral injury, acute cerebral hemorrhage, brain infarction).

2. active neuromuscular diseases that limiting patient to physical training (e.g. amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis, polymyositis, muscular dystrophy).

3. severe thoracic or abdominal trauma.

4. acute myocardial infarction, severe arrhythmia, acute heart failure, hemo-dynamic instability or shock.

5. drug abuse, alcohol addiction, opiates or other drug dependence and psychiatric disorder history.

6. known pregnancy.

7. malignant tumor, cachexia, end stage of chronic illness.

8. contraindications to rehabilitation therapy.

9. inability to obtain an informed consent from patient or a proxy.

10. any other factors such as fractures or limb malformation, that would prevent response to physical exercise or cause injury to the patient.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southern Medical University, China

OTHER

Sponsor Role: collaborator

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wang Hua

Vice Director of Critical Care Department, Zhujiang Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yan Zhang

Role: STUDY_DIRECTOR

Zhujiang Hospital

Central Contacts

Hua Wang

Role: CONTACT

icuwanghua@163.com

+86 18665000903

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Other Identifiers

LC2016PY036

Identifier Type: -

Identifier Source: org_study_id