Status:
COMPLETED
Muscle Wasting in the Critically Ill
Lead Sponsor:
University of Liverpool
Conditions:
Muscle Weakness
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Muscle wasting is a common consequence of critical illness, and has a profound impact upon the rehabilitation of those who survive admission to critical to care. The investigators intend to assess if ...
Detailed Description
Patients are mechanically ventilated and sedated with a diagnosis of sepsis (from any source) will be eligible for this study. Provided they meet the inclusion criteria, they will be randomised within...
Eligibility Criteria
Inclusion
- Patients will be recruited in the Intensive Care Unit of the Royal Liverpool University Hospital. All patients will be over 18, and have a critical illness that requires mechanical ventilation with an initial period of sedation. This study will focus on patients with a definite or suspected case of sepsis from any source.
- Sepsis has been recently redefined as: "Life threatening organ-dysfunction caused by dysregulated host response to infection" whilst septic shock has become a subset of sepsis, defined as: "circulatory and cellular/metabolic dysfunction associated with a higher risk of mortality(44).
- For the purposes of this study, a patient will be regarded as septic if they have evidence of infection-related organ failure (e.g. sepsis-associated coagulopathy, altered mental state, cardiovascular dysfunction, acute kidney injury, and altered liver function) and require invasive mechanical ventilation with either definite or suspected evidence of infection. This is to allow prompt treatment with FES rather than waiting for a positive microbiological result to be obtained.
- Within the definition of sepsis "from any source" a list of following is illustrative but not exhaustive:
- Urogenital sepsis (including urosepsis, pyelonephritis, endometritis and chorioamnionitis)
- Pneumonia (including community acquired, hospital acquired, and aspiration pneumonia. Ventilator associated pneumonia would be excluded.)
- Neurological infections such as encephalitis and meningitis.
- Cellulitis, osteomyelitis and infections of soft tissue NOT affecting the lower limb.
- Surgical infections, including post-operative laparotomy with evidence of peritoneal soiling, and evidence of infection prior to the operation, in patients who require 2 or more organ system support after the operation.
- Intra-abdominal sepsis, including biliary sepsis, hepatitis, and acute pancreatitis. In the case of acute pancreatitis, evidence of infection is required to fulfil the criteria. Acute pancreatitis with sterile tissue/fluid samples would not be suitable.
Exclusion
- Patients under 18
- Patients who decline consent
- Pregnancy
- Neuromuscular disease
- Rhabdomyolysis
- Lower limb trauma
- Patients unlikely to survive to 96 hours post admission
- Consent unobtainable within 48 hours of admission
- Morbid obesity (BMI\>40).
- Presence of a pacemaker or Implantable Cardiac Defibrillator (ICD).
- Unlikely to be mechanically ventilated for more than 48 hours.
Key Trial Info
Start Date :
January 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03770442
Start Date
January 14 2019
End Date
November 1 2020
Last Update
November 4 2020
Active Locations (1)
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1
Intensive Care Unit, Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8XP