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Background Whether screening for chronic kidney disease (CKD) can improve the care of persons at high risk for complications remains uncertain. We describe the design and early implementation experience of a pilot, cluster-randomized pragmatic trial to evaluate the feasibility, implementation, and effectiveness of a “triple marker” CKD screening program (creatinine, cystatin C and albumin to creatinine ratio) for improving care among hypertensive veterans seen in primary care at one Veterans Administration Hospital. Methods/design Non-diabetic hypertensive veterans age 18–80 without known CKD were randomized in clusters determined by primary care provider (unit of randomization) into three arms. Usual care will be compared with two incrementally intensified treatment strategies: (1) screen for CKD followed by patient and provider education or (2) screen-educate plus a clinical pharmacist-led CKD and BP management program. The primary clinical outcome is systolic blood pressure (BP) change from baseline. Secondary clinical outcome is BP control. The primary process outcomes is triple marker screening (across three arms), and secondary process outcomes include use of inhibitors of the renin-angiotensin system (ACE/ARB) overall and in persons with albuminuria, CKD recognition by PCP, use of non-steroidal anti-inflammatory drugs (NSAIDs) and NSAID education by PCP. The design uses the Veterans Health Administration electronic health record (EHR) to identify participants, deliver the interventions and ascertain study outcomes. Assessment of the program implementation will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Study duration is 12 months. Results A total of 1,819 patients have been randomized within 41 provider clusters. The median age (interquartile range) is 68 years (61–72), and 99% of participants are male. Approximately 16% are Black, and 5% Hispanic. In the first 6 months of the trial, 434 triple marker screening tests have been ordered, and 217(50%) have been tested. A total of 48 new CKD cases have been identified among those tested, for a preliminary yield of 22%. Conclusion We have successfully implemented a pragmatic protocol that uses the EHR to identify and characterize eligible participants, deliver the intervention, and ascertain study outcomes with high rates of participation by providers and patients. Results from this study can guide design of pragmatic trials in the field of CKD. Trial registration NCT02059408 ; Date or Registration: 1/17/2014.

Intravenous albumin is recommended for hepatorenal disorders (HRD), but individuals who do not recover renal function may be at a high risk for pulmonary edema. We reviewed outcomes by the amount of albumin infused in 93 patients not receiving dialysis at admission but being treated with intravenous albumin for acute HRD at our institution. Absence of renal recovery was defined as no decrease in serum creatinine and requirement of dialysis during hospitalization, and partial renal recovery was defined as a decrease in serum creatinine but not to prehospitalization levels. Associations of clinical factors including total albumin infused, presence of renal recovery, and oliguria with the development of pulmonary edema during hospitalization were determined using logistic regression. Of the 93 patients, 20 patients had complete renal recovery, 17 patients had partial renal recovery, and 56 patients showed no renal recovery. Most patients received 300–600 g of albumin. Overall, 47.3% of patients developed pulmonary edema (n=44), but the risk was 75% in patients with oliguria on presentation and no renal recovery versus 17% in those with no oliguria and complete renal recovery (P<0.001). In the logistic regression model, oliguria (3.32; 95% confidence interval [CI]: 1.12, 9.81) and no renal recovery (3.38; 95% CI:1.24, 9.16) were each associated with higher odds of pulmonary edema after adjustment for covariates. No association was noted between total albumin infused and pulmonary edema. In summary, absence of renal recovery and oliguria in patients with HRD receiving intravenous albumin is associated with a higher risk of pulmonary edema.