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ID
Source
Brief title
Health condition
Intensive Care Unit (ICU)-acquired weakness
Sponsors and support
Intervention
Outcome measures
Primary outcome
Predictive performance (discrimination, calibration and classification) of a risk prediction model for ICU-AW.
Secondary outcome
Predictive performance after updating of the prediction model.
Background summary
Intensive Care Unit–acquired weakness (ICU–AW) is a frequent and debilitating complication of critical illness. It is important to identify ICU-AW early after onset of critical illness to provide accurate prognostic information to patients and their families and to enable timely initiation of supportive interventions, like intensive physiotherapy and tracheostomy. Using the current diagnostic reference standard, assessment of muscle strength using the Medical Research Council (MRC) score, an early diagnosis of ICU–AW is frequently precluded due to impaired consciousness or attentiveness.
A prediction model using easily available data might be able to predict the risk of ICU-AW and might enable early interventions. In a previous study, we found that it was possible to predict the risk of ICU-AW using simple and widely available data. However, that risk prediction model was based on single center data which limits the generalizability. Therefore we aim to validate and update the risk prediction model for ICU-AW using prospective data from multiple centers.
Study objective
A risk prediction model, using patient characteristics, early available clinical parameters, laboratory results and use of medication as parameters could reliably predict the risk of ICU-AW two days after ICU admission.
Study design
At 48 hours after ICU admission, after screening of the in-and exclusion criteria, the patient will be included in the study. Thereafter the candidate predictors will be collected from the patient file. As soon as the patient is awake and attentive the attending physiotherapist will assess the muscle strength of the patient.
Intervention
At 48 hours after ICU admission, patient characteristics, early available clinical parameters, laboratory results and use of medication parameters will be collected from the patient file. The candidate predictors are: age, gender, pre-existent polyneuropathy, polyneuropathy risk factor, systemic corticosteroid use prior to ICU admission, unplanned admission, suspected sepsis, presence of shock, RASS score, average urine production, highest glucose, lowest glucose, lowest pO2, FiO2 at lowest pO2, lowest pH, highest lactate, lowest platelets, lowest ionized calcium, highest ionized calcium, lowest phosphate, red blood cell transfusion, treatment with any corticosteroid, repeated treatment with any neuromuscular blocker and treatment with any aminoglycoside.
Muscle strength will be investigated by the attending physiotherapist, using the Medical Research Council (MRC) sumscore to assess the presence of ICU-AW.
Inclusion criteria
-Adult patients newly admitted to the ICU
-Mechanically ventilated at 48h after admission
Exclusion criteria
- Cardiac arrest, any central nervous system (CNS) disorder (stroke, traumatic brain or spinal injury, CNS infection, CNS tumor) or neuromuscular disease as reason for admission
- Pre-existing spinal injury
- Poor pre-hospital functional status (modified Rankin score ≥4)
- Poor prognosis; death likely within 48 hours after inclusion
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL4180 |
NTR-old | NTR4331 |
Other | METC reference number : W13_193#13.17.0239 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |