Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunctio View Homepage


Ontology type: schema:MonetaryGrant     


Grant Info

YEARS

2010-2015

FUNDING AMOUNT

964437.0 GBP

ABSTRACT

s are not currently available in GtR for all funded research. This is normally because the abstract was not required at the time of proposal submission, but may be because it included sensitive information such as personal details. Technical Summary Scientific Abstract|The first section details the plan for undertaking a phase 2 randomised trial to test the effectiveness and safety of simvastatin in ALI/ARDS (Objective 1). The second section describes the studies of biological markers of inflammation and lung injury to provide insight into the mechanism of action of simvastatin in ALI/ARDS (Objective 2).|Objective 1:|Design: This will be a prospective, randomised, double-blind, placebo-controlled phase 2 multi-centre, clinical study of simvastatin in patients with ALI/ARDS.|Setting: Fourteen adult general ICUs.|Target population: Mechanically ventilated, intubated adult patients with ALI/ARDS defined according to the American-European Consensus Conference definition. Exclusion criteria will include: age <16 years old; more than 48 hours from the onset ALI; pregnancy; creatine kinase (CK) >10 x upper limit of the normal range; transaminases >5 x upper limit normal; CYP3A4 inhibitors as listed in the detailed project description; severe renal impairment (calculated creatinine clearance less than 30ml/minute) not receiving renal replacement therapy, severe liver disease (Childs Pugh score > 11); domiciliary mechanical ventilation; current or recent treatment (within 2 weeks) with statins; participation in other trials within 30 days; contraindication to enteral drug administration; and consent declined.|Interventions: Patients will be randomised to receive once daily simvastatin 80mg or identical placebo tablet administered enterally via a feeding tube or orally for up to 28 days.|Outcomes and duration of follow-up: The primary clinical efficacy outcome will be ventilator free days (VFDs). VFDs are the number of days after initiating unassisted breathing to day 28 after randomisation, assuming a subject survives for at least 48 hours after initiating unassisted breathing. VFDs represent a validated outcome measure which quantifies the number of days alive and free from mechanical ventilation. It remains the most useful and validated clinical outcome measure in phase 2 clinical trials in ALI/ARDS.|The following secondary outcomes will also be assessed: 1) pulmonary dysfunction; as measured by oxygenation index (OI), which measures both impaired oxygenation and the amount of mechanical ventilation delivered; 2) non-pulmonary organ failure as measured by the SOFA score; 3) 28 day mortality; 4) safety and tolerability as assessed by the frequency of serious adverse events and suspected unexpected serious adverse reactions (SUSARs); 5) Health-related quality of life (QoL) as assessed using the self-administered EuroQol-5D (EQ-5D) postal questionnaire; and 6) cost effectiveness.|Patient data will be recorded in the case record form daily by the research nurse until day 28. Follow-up at 3, 6 and 12 months will use a postal questionnaire containing the EQ-5D and resource use questions for the health economic analysis.|Objective 2:|We will test the hypothesis that simvastatin decreases neutrophil activation, pro-inflammatory cytokines and adhesion molecule expression, and will explore whether this occurs by reduced NFkB activation. Furthermore, we will investigate whether simvastatin reduces plasma levels of cell-specific indices of activation and injury to the alveolar epithelium and the endothelium. We shall also assess simvastatins effect on lung extracellular matrix destruction.|Blood and urine will be taken on days 0, 3, 7, 14 and 28.|Sample size: The mean (standard deviation; SD) VFDs in 432 patients with ALI/ARDS was 12.7 (10.6) days. On the basis of published data, a conservative treatment effect of 20% has been estimated for this study. A 20% treatment effect represents a 2.6 day increase in VFDs. A 2.6 day increase in VFDs either as a result of improved mortality and/or decreased duration of ventilation would be of major importance. A sample size of 524 subjects (262 in each group) will have 80% power at a two-tailed significance level of 0.05 to detect a 20% difference More... »

URL

https://gtr.ukri.org/project/ECBF459D-1E5D-454E-A3CC-11E2C7212B58

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    241 grid-institutes:grid.7445.2 schema:Organization
     




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