Acute Respiratory Distress Syndrome Clinical Trial
— CLEVEREROfficial title:
Prospective Observational Study Regarding the Determinants of Functional Disability and Quality of Life in Patients Recovering From Severe Acute Cardiac or Respiratory Failure Considered for Mechanical Cardiorespiratory Support (CLEVERER)
To observe and identify determinants of recovery from intensive care unit-acquired weakness (ICUAW) following a severe cardiorespiratory failure requiring extra-corporeal membrane oxygenation (ECMO). Additionally, to discover the effects of ICUAW on physical function and health-related quality of life (HRQoL) after critical illness. CLEVERER is a clinical observational pilot study.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 26, 2024 |
Est. primary completion date | September 26, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Above the age of 18 - Adults with severe cardio-respiratory failure requiring ECMO. - Adults who have had personal and professional consultees agree to enrol them in the trial. Exclusion criteria: - Previous Stroke - Neuromuscular disease - Malignancy - Underlying neuromuscular disease - paediatrics |
Country | Name | City | State |
---|---|---|---|
United Kingdom | St Bartholomew's hospital (Barts NHS trust) | London |
Lead Sponsor | Collaborator |
---|---|
Barts & The London NHS Trust | Queen Mary University of London |
United Kingdom,
Bloch SA, Donaldson AV, Lewis A, Banya WA, Polkey MI, Griffiths MJ, Kemp PR. MiR-181a: a potential biomarker of acute muscle wasting following elective high-risk cardiothoracic surgery. Crit Care. 2015 Apr 7;19(1):147. doi: 10.1186/s13054-015-0853-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To observe the change in cross sectional area of the Rectus Femoris (RFcsa, measured in cm2) during critical illness and recovery. | RFcsa will be calculated using B-mode ultrasound (US) at pre-determined time points. Additionally, the images acquired will have histogram analysis in adobe photoshop software. The RFcsa will be correlated with indices of muscle strength and HRQoL. A larger RFcsa with reduced pixel density suggests greater muscle quality and function. | Up to approximately 1 year. | |
Primary | To Observe a change in Hand Held Dynamometry strength and correlate this with RFcsa, function and HRQoL during critical illness and recovery. | Hand-held dynamometry will be calculated using the JAMAR hand-held hydraulic dynamometer. We will assess both hands and take the mean of 3 trials, producing a maximal grip result. A higher score indicates better global strength and function. | Up to approximately 1 year. | |
Primary | To observe a change in Knee straightening dynamometry, strength and joint moment (torque) and correlate this with RFcsa, function and HRQoL during critical illness and recovery. | The test will be conducted using a Lafayette Manual Muscle Tester. Joint knee moment (torque) and strength will be measured. A higher result from joint knee moment and strength indicates a greater global strength and function. | Up to approximately 1 year | |
Primary | To test the Medical Research Council Sum Score (MRC-SS). MRC-SS measures global strength and ambulation | This test will be conducted once to reaffirm whether patients' have ICUAW. A score can range from 0 (paralysis) to 60 (normal strength). A score of less than 48 indicates the patient has ICUAW. Therefore, a lower score is associated with worse outcomes. | Up to approximately 1 year. | |
Primary | To observe a change in Short Physical Performance Battery (SPPB) and correlate this with RFcsa, function and HRQoL during critical illness and recovery | SPPB will be used as a further marker of functional status. The patient can score between 0 (poor functional status) and 12 (good functional status). | Up to approximately 1 year. | |
Primary | Lying and Standing Vital Capacity (FVC - forced vital capacity) and correlate this with RFcsa, function and HRQoL during critical illness and recovery. | Lying and standing vital capacity will be measured using a hand held spirometer. The test score will be compared to the predicted normal value based on age, height, race and gender. A result is considered normal if it is 80 percent or more of the predicted value. | Up to approximately 1 year | |
Primary | To measure a change in Free Fat Mass Index (FFMI) and correlate this with RFcsa, function and HRQoL during critical illness and recovery. | Free fat mass index (FFMI) and free fat mass (FFM) will be measured using the bodystat 1500 device. Other values will also be recorded from the test including body fat percentage and lean mass percentage. The body stat 1500 is an electrical device that uses electrical impedance to obtain results (objective data). Results will be compared to predicted values based on age, sex, height and weight. | Up to approximately 1 year | |
Primary | To measure the EQ-5D-5L (Euroscore) to assess general health and correlate this with the primary objective (RFcsa). | EQ5D-5L is a standardised tool that provides a simple generic measure of health. A summation of all the levels will be converted to a single index value using the EQ5D-5L crosswalk index value calculator. The general health score can range from 0 (worst health imaginable) to 100 (best health imaginable). Additionally, a health state ranging from level 1 (indicating no problem) to level 5 (indicating extreme problems) can be calculated using the descriptive system and its five dimensions. | Up to approximately 1 year | |
Primary | Hospital anxiety and depression score (HADS) to assess HRQoL and correlate this with the overall primary objective (RFcsa). | The HADS is an assessment that measures whether a patient is suffering from anxiety or depression. HADS is a self assessment consisting of 16 items. A result between 0 and 7 indicates a normal case, between 8 and 10 indicates borderline abnormal and between 11 and 21 indicates abnormal levels of anxiety and depression. | Up to approximately 1 year | |
Primary | Reintegration to normal living index (RNLI) to assess HRQoL and correlate this with the overall primary objective (RFcsa). | The RNLI is a 5 domain 11-tool item aimed at assessing the degree to which patients' who have experienced traumatic and incapacitating illness achieve reintegration into society. The RNLI score is based out of 110, which will be proportionally converted to create a score of 100. Zero indicates no integration whereas 100 implies full integration. | Up to approximately 1 year | |
Primary | 10-item questionnaire to assess HRQoL (pre-morbid functional status) and correlate this with the overall primary objective. | This is a locally devised questionnaire that is answered by the patients' next of kin due to them being incapacitated. We will correlate these results with the other HRQoL questionnaires. | Day 0 (on admission) | |
Secondary | The secondary aim is to understand the molecular profile (bloods). | Blood analysis will contain and analyse but not limited to markers of oxidative stress injury, inflammation, MiRNA and injury to multiple organs will be quantified. We will collect, store and analyse buffy coat and plasma to understand these profiles. | Up to approximately 1 year | |
Secondary | Urine Analysis | Urine analysis measures albumin-creatinine ratio (ACR). | Up to approximately 1 year | |
Secondary | Muscle Biopsy | A muscle biopsy will be taken from patients whilst under anaesthesia. The biopsy observes pathways relevant to muscle homeostasis using biochemical and molecular techniques. | Intra operatively | |
Secondary | Vascular endothelial cell sampling | Cell samples will be acquired from insertion of the central line. | Day 0. | |
Secondary | Cardiac post operative morbidity score (C-POMS) will be used to calculate total morbidity risk. | C-POMS is additional data that will be collected and analysed. C-POMS is a validated tool assessing in-hospital morbidity burden (score 0-13) derived by noting the presence of 13 morbidity domains (pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, haematological, wounds, pain, endocrine, electrolytes, review and assisted ambulation) on days 3, 5, 8 and 15 after cardiac surgery. A higher score indicates a greater morbidity burden. Although ECMO is not considered cardiac surgery we can still utilise C-POMS as a descriptive measure. | Time Frame: Day 3, day 5, day 8 and day 15 post ECMO initiation. |
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