Acute Kidney Injury Clinical Trial
Official title:
Preconditioning Against Renal Damage Under Contrast Examination: a Single Centre, Randomized, Sham -Controlled Clinical Feasibility Trial
This study aims to assess if applying an ischaemic insult to an arm before giving
intravenous contrast will help decrease the incidence of developing contrast induced acute
renal injury in patients undergoing contrast-enhanced CT Scans.
The main research question is 'In adult in-patients undergoing contrast-enhanced CT scans,
does remote ischaemic pre-conditioning (RIPC) induced by brief arm ischaemia and
reperfusion, when compared to control, reduce the proportion of patients developing
contrast-induced acute kidney injury in the first 3 post-scan days? '.
Intravenous contrast for diagnostic and therapeutic interventions is a leading cause of
hospital-acquired acute renal failure (1). Contrast-induced acute kidney injury (CI-AKI)
occurs through a complex mechanism including toxic and hypoxic renal tubular injury,
diminished renal parenchymal circulation and renal endothelial dysfunction with the
production of oxygen free radicals due to post-ischaemia oxidative stress (2). With
increasing numbers of diagnostic and therapeutic interventions, the incidence of CI-AKI will
rise over the next few decades. Already, 40% of general surgical in-patients undergo
cross-sectional imaging with computed tomography (CT), largely using contrast (3). Optimal
clinical care in many specialties such as oncology, emergency medicine and surgery relies
upon information derived from contrast-enhanced cross-sectional imaging. In consequence,
large numbers of patients are exposed to the risk of CI-AKI. Current CI-AKI preventive
measures comprise identification of at-risk patients, minimisation of contrast dose and the
use of intravenous volume expansion (4). Simple, cost-effective methods to reduce CI-AKI are
required.
Risk factors for CI-AKI include advanced age, diabetes mellitus, pre-existing renal
insufficiency and congestive cardiac failure. Dehydration also increases the risk (5). While
patients over the age of 65 years currently account for 11% of the Irish population, they
account for 30% of surgical admissions (6). In a recent cohort study of 1800 surgical
in-patients in a major Irish teaching hospital, acute renal failure was a common major
complication, occurring in 2.4% of patients (6). Multivariate analysis of this cohort
demonstrated that increasing age and emergency admission were both independent risk factors
for complications (6). Emergency surgical patients constitute a high-risk group in whom
simple methods to minimise complications are required.
Remote ischaemic preconditioning (RIPC) is a simple technique whereby brief periods of
skeletal muscle ischaemia and reperfusion triggers a period of resistance to
ischaemia-reperfusion injury in distant tissues e.g. heart or kidney (7). It reduces renal
damage following endovascular aneurysm repair, a procedure requiring considerable
contrast-volumes (8). A recent meta-analysis demonstrated that RIPC significantly reduced
post-procedure creatinine levels following cardiovascular procedures, though there was
considerable clinical heterogeneity between the included trials (9). We hypothesise that
RIPC induced using brief periods of upper limb ischaemia-reperfusion will reduce AKI in
patients undergoing contrast enhanced CT scans.
The hypothesis that RIPC will reduce CI-AKI was first explored by Whittaker and Pryzklenk
(10). They utilised available data from a patient cohort undergoing emergency coronary
angioplasty. Patients with 1 to 3 balloon inflations in the coronary artery served as the
control group whilst those with >3 balloon inflations served as the RIPC group.Both groups
displayed an immediate improvement in estimated glomerular filtration rate (eGFR). However,
the control group then displayed a statistically significant decrease in eGFR by day 3
post-procedure (77 +14 ml/min/1.73m2 versus 70 +12 ml/min/1.73m2). The RIPC group displayed
no such difference by day 3 (81 +21 ml/min/1.73m2 versus 80 +14 ml/min/1.73m2) despite
having received a larger contrast volume. This observation implied a potential protective
effect for RIPC.
Greater availability of CT technology has led to a dramatic increase in the number of
patients undergoing ce-CTAP in recent years. Between 1996 and 2010, the number of patients
undergoing CT scans in the United States tripled, increasing by 8% per annum (11).
Simultaneously, an increasingly elderly and sick population means that many patients now
have multiple co-morbidities, increasing their risk of contrast-induced acute kidney injury.
Approximately 6.5% of patients undergoing ce-CT develop acute kidney injury defined as a
>25% increase in serum creatinine from baseline (12). Simple methods to reduce CI-AKI are
required. We propose that the use of remote ischaemic preconditioning could be a simple,
cost-effective measure that could decrease the incidence of CI-AKI in high risk patients
undergoing contrast enhanced CT scans.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
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