|- candidate number||21162|
|- NTR Number||NTR4921|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-dec-2014|
|- Secondary IDs|| |
|- Public Title||Acute kidney injury in patients treated for symptomatic peripheral arterial disease |
|- Scientific Title||Contrast-induced nephropathy in patients undergoing percutaneous transluminal angioplasty in symptomatic peripheral artery disease – A prospective cohort study. |
|- ACRONYM||CIN in patients treated with PTA|
|- hypothesis||The authors hypothesized that patient experiencing CIN would have greater annual mean renal decline following endovascular interventions, compared to patients that not develop CIN. |
|- Healt Condition(s) or Problem(s) studied||Limb ischemia, Peripheral Arterial Disease, Chronic kidney disease, Intermittent claudication, Percutaneous Coronary Intervention (PCI), Kidney disease|
|- Inclusion criteria||All patients presenting at the department of vascular surgery between May 1st 2013 and February 15th 2014 |
|- Exclusion criteria||Exclusion criteria were end-stage renal disease (ESRD), no renal function test, any CT-angiography or percutaneous coronary intervention in the first year of follow-up|
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||Single arm|
|- planned startdate ||1-mei-2013|
|- planned closingdate||1-feb-2015|
|- Target number of participants||350|
|- Interventions||Endovascular procedures for symptomatic peripheral artery disease|
|- Primary outcome||Acute kidney injury (contrast-induced nephropathy) CIN was determined as a >25% increase of baseline creatinine level day 5 post-procedural|
|- Secondary outcome||Renal decline 1 year after endovascular interventions|
|- Timepoints||1 Creatinine pre-procedural: (maximum 6 months prior to intervention (PTA), 2 Creatinine Post-procedural: (5 days post intervention), 3 Creatinine 30 days. (According to local post-contrast administration protocol). |
2: Pre-procedural estimated glomerular filtration rate (eGFR) and one year post-procedural eGFR difference were analysed. The estimated GFR was calculated from serum creatinine using the Modification of Diet in Renal Disease (MDRD) Study equation: MDRD GFR (mL/min/1.73 m2) = 30849 × [standardised serum creatinine (micromole/L)]-1.154 × [age (years)]-0.203 × 1.212 (if African American) × 0.742 (if female)6. Vital sign data closest in time and before (but within 12 months of) the index date were used for analyses.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Drs. T.A. Sigterman|
|- CONTACT for SCIENTIFIC QUERIES||Drs. T.A. Sigterman|
|- Sponsor/Initiator ||Atrium Medical Center, Heerlen|
(Source(s) of Monetary or Material Support)
|- Brief summary||Comprehensive literature has been published regarding contrast-induced nephropathy (CIN) following percutaneous coronary intervention (PCI). However, limited data is known regarding CIN after percutaneous transluminal angioplasty (PTA) in patients with symptomatic peripheral arterial disease (PAD). CIN is defined as an increase in serum creatinine by more than 25% or 44umol/L during 3 days post-operative. Contrast-induced nephropathy characteristically manifests 3 days after administration of the contrast medium, with a peak in kidney function decline 3 to 5 days after contrast administration.
Acute kidney injury can occur frequently in vascular surgery patients. Though, the wide range of definitions available for acute renal injury makes comparisons of different studies difficult. Although, the overall incidence of CIN following PCI was recently reported 14.5% in a large epidemiologic study (defined as > 25% increase in serum creatinine levels over baseline in the first 5 days). Moreover, incidence of CIN varies from 0% to 90%, depending on the presence of risk factors, most notably chronic kidney disease (CKD), diabetes mellitus and administration of high contrast volume.
Contrast-induced nephropathy is after surgery and hypotension, the third most common cause of hospital-acquired acute kidney injury. Many studies have shown that patients developing CIN have a greater risk for prolonged hospitalization, cardiovascular events and death. Furthermore, when patients with acute kidney injury require dialysis, mortality is even higher compared to those not requiring dialysis. For example, McCullough et al. show a hospital mortality of 7.1% in CIN and 35.7% in patients who required dialysis referentie.
To the best of the authors knowledge limited literature is available on CIN in symptomatic PAD patients treated with PTA. The aim of this study was to analyze the incidence of contrast-induced nephropathy in symptomatic PAD patients undergoing PTA. Secondly, identifying risk factors associated with the development of CIN. The authors hypothesized that patient experiencing CIN would have greater annual mean renal decline following endovascular interventions, compared to patients that not develop CIN.
|- Main changes (audit trail)|
|- RECORD||16-dec-2014 - 1-feb-2015|