EPIdemiology of Surgery-Associated Acute Kidney Injury (EPIS-AKI) : Study protocol for a multicentre, observational trial

More than 300 million surgical procedures are performed each year. Acute kidney injury (AKI) is a common complication after major surgery and is associated with adverse short-term and long-term outcomes. However, there is a large variation in the incidence of reported AKI rates. The establishment of an accurate epidemiology of surgery-associated AKI is important for healthcare policy, quality initiatives, clinical trials, as well as for improving guidelines. The objective of the Epidemiology of Surgery-associated Acute Kidney Injury (EPIS-AKI) trial is to prospectively evaluate the epidemiology of AKI after major surgery using the latest Kidney Disease: Improving Global Outcomes (KDIGO) consensus definition of AKI. EPIS-AKI is an international prospective, observational, multicentre cohort study including 10 000 patients undergoing major surgery who are subsequently admitted to the ICU or a similar high dependency unit. The primary endpoint is the incidence of AKI within 72 hours after surgery according to the KDIGO criteria. Secondary endpoints include use of renal replacement therapy (RRT), mortality during ICU and hospital stay, length of ICU and hospital stay and major adverse kidney events (combined endpoint consisting of persistent renal dysfunction, RRT and mortality) at day 90. Further, we will evaluate preoperative and intraoperative risk factors affecting the incidence of postoperative AKI. In an add-on analysis, we will assess urinary biomarkers for early detection of AKI. EPIS-AKI has been approved by the leading Ethics Committee of the Medical Council North Rhine-Westphalia, of the Westphalian Wilhelms-University Münster and the corresponding Ethics Committee at each participating site. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and used to design further AKI-related trials. Trial registration number NCT04165369

All-cause mortality among diabetic foot patients and related risk factors in Saudi Arabia.

Although Diabetes mellitus is a major public health problem in the Middle East and North Africa (MENA) region with high rates of diabetic foot complications, there are only limited data concerning mortality among such a high risk group. Therefore, the main aim of the current study was to assess all-cause mortality and its related predictors among diabetic patients with and without diabetic foot complications.Using data from the Saudi National Diabetes Registry (SNDR), a total of 840 patients with type 1 or type 2 diabetes aged ≥25 years with current or past history of diabetic foot ulcer (DFU) or diabetes related lower extremity amputation (LEA) were recruited in 2007 from active patients' files and followed up to 2013. These patients were compared with an equal number of age and gender matched diabetic patients without foot complication recruited at the same period. All patients were subjected to living status verification at 31st December 2013.The all-cause mortality rate among patients with DFU was 42.54 per 1000 person-years and among LEA patients was 86.80 per 1000 person-years among LEA patients for a total of 2280 and 1129 person-years of follow up respectively. The standardized mortality ratio (SMR) (95% CI) was 4.39 (3.55-5.23) and 7.21 (5.70-8.72) for cases with foot ulcer and LEA respectively. The percentage of deceased patients increased by almost twofold (18.5%) among patients with diabetic foot ulcer and more than threefold (32.2%) among patients with LEA compared with patients without diabetic foot complications (10.7%). The worst survival was among patients with LEA at 0.679 and the presence of diabetic nephropathy was the only significant independent risk factor for all-cause mortality among patients with diabetic foot complications. On the other hand, obese patients have demonstrated significantly reduced all-cause mortality rate.Diabetic patients with diabetic foot complications have an excess mortality rate when compared with diabetic counterparts without foot complications and the general population. Early interventions to prevent foot ulceration and consequent LEA as well as all the measurements for reducing the prevalence of microvascular and macrovascular complications should be considered

Cumulative Kaplan–Meier survival curves for diabetic patients with or without foot complications.

<p>Footnote: P value between patients with diabetic foot ulcer (DFU) and diabetic patients without foot complications is < 0.001. P value between patients with lower extremities amputation (LEA) and diabetic patients without foot complications is < 0.001.</p

Flow chart of the mortality among diabetic foot patients from Saudi National Diabetes Registry (SNDR) aged ≥25.

<p>Flow chart of the mortality among diabetic foot patients from Saudi National Diabetes Registry (SNDR) aged ≥25.</p

Mean (SD) for clinical and biochemical characteristics of the selected patients aged ≥ 25 years by diabetic foot state.

<p>Mean (SD) for clinical and biochemical characteristics of the selected patients aged ≥ 25 years by diabetic foot state.</p

Unadjusted and adjusted^* Cox proportional hazards regression for all-cause mortality for diabetic foot non-diabetic foot in the registered diabetic patients.

<p>Unadjusted and adjusted^{<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0188097#t004fn001" target="_blank">*</a>} Cox proportional hazards regression for all-cause mortality for diabetic foot non-diabetic foot in the registered diabetic patients.</p