Early Physical Therapy in Patients With Sepsis

NCT01787045 | Terminated

• 1 other identifier: EarlyPTProtocol1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

It is clearly shown that patients in the Intensive care Unit (ICU) with severe sepsis or multi organic failure are very susceptible to develop neuromuscular complications. That can be attributed to a hyper catabolic state, general inflammation and immobilization. This can leads a significant muscle wasting, polyneuropathy and/or myopathy. These alterations have been defined with the term Intensive Care Acquired Weakness (ICUAW) and can leads important functional squeals and impaired quality of life for months, years and in some cases irreversibly. To overcome these complications, early activation by physiotherapy becomes an important tool. This type of treatment has been show to be feasible, safe and improves the functional capacity of patients. In addition to a reduction in the duration of ICU and hospital stay and improved quality of life for patients. The objective of this study is to demonstrate that the early and active physical activity in patients with severe sepsis can limit the loss of muscle mass and complications related to this type of damage. Procedures: Patients or relatives will be asked to participate in the study. If a positive response is done, patients will be randomized in an intervention or control group. A baseline evaluation will be performed during the first day of study admission. That includes a physical exploration, electrophysiological studies, skeletal muscle histological/biochemical evaluations and monitoring of blood biomarkers and others clinical outcomes will be registered. Intervention will be divided in a morning and afternoon times, patient will be positioned in chair or bed and mobilized by physiotherapist. As usual, all patients will be attaining manual mobilization for 20 minutes twice a day. Only for intervention group, additional cycle-ergometer exercise will be performed for 30 minutes at better performance achieved and tolerated for patient. All vitals parameters will be strictly controlled before, during and after intervention. The same baseline evaluation will be repeated after day 7 and clinical outcomes will be registered until ICU discharge.

Conditions

SEPTIC SHOCK; SEPSIS SYNDROME; Multiple Organ Dysfunction Syndrome

Keywords

SEPSIS

Outcome Measures

Primary Outcomes (1)

• Change in activation of skeletal muscle synthetic and catabolic pathways.

  Within the first 7 days (plus or minus 1 days)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Early and Active Physical Therapy will be performed by physiotherapist twice a day. During first week patients will be positioned in chair or bed and performed cycle-ergometer exercise during 30 min. Our physiotherapy protocol will be continued until Intensive Care Unit (ICU) discharge.

Other: Early and Active Physical Therapy; Other: Passive Range of Motion

Control Group

OTHER

Routinary Passive Range of Motion will be performed by physiotherapist 20 min and twice a day until ICU discharge.

Other: Passive Range of Motion

Interventions

Early and Active Physical Therapy OTHER

Cycle-ergometer exercise will be performed in the more active manner tolerated by patient. Potency attained will be registered during 30 min of exercise. Our physiotherapy protocol includes also others exercises like ambulation with assistance, cycle-ergometer for arms and legs, etc.

Also known as: Early Physical Rehabilitation, Early Physical Training, Early Physiotherapy, Early Mobilization, Very Early Mobilisation, Early Exercise, Early Activity, Early Mobility Therapy

Intervention Group

Passive Range of Motion OTHER

Passive mobilization will be performed in all limbs as 10 repetitions of every range of motions. Extension position will be maintained for some seconds to attaint muscular elongation in every muscular group.

Also known as: Passive Range of Motion (PROM), Passive Mobilization, Articular mobilization, Routinary Passive Range of Motion, Usual manual mobilization

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemodynamically stable patients.
• Admitted to ICU for sepsis or MOF (multiple organ failure) or who developing during their ICU stay within the first 24 hours of the ICU admission.
• With an expected ICU stay of at least 7 days.

You may not qualify if:

• Patients without approved consent.
• Patients with a known neuromuscular disorder before ICU admission.
• Moribund patients.
• Severe metabolic/hemodynamic instability despite pharmacological support.
• Having conditions that impair evaluation techniques or intervention methods.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)

Brussels, Brussels Capital, 1200, Belgium

Location

Related Publications (1)

• Hickmann CE, Castanares-Zapatero D, Deldicque L, Van den Bergh P, Caty G, Robert A, Roeseler J, Francaux M, Laterre PF. Impact of Very Early Physical Therapy During Septic Shock on Skeletal Muscle: A Randomized Controlled Trial. Crit Care Med. 2018 Sep;46(9):1436-1443. doi: 10.1097/CCM.0000000000003263.

  PMID: 29957714 DERIVED

MeSH Terms

Conditions

Shock, Septic; Systemic Inflammatory Response Syndrome; Multiple Organ Failure; Sepsis

Interventions

Early Ambulation; Range of Motion, Articular

Condition Hierarchy (Ancestors)

Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Pierre-François Laterre, Professor

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain (StLuc)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 8, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

BE (1)