Olanzapine for the Prevention of Postdischarge Nausea and Vomiting after Ambulatory Surgery: A Randomized Controlled Trial.

BACKGROUND: Postdischarge nausea and vomiting after ambulatory surgery is a common problem that is not adequately addressed in current practice. This prospective, randomized, double-blind, parallel-group, placebo-controlled study was designed to test the hypothesis that oral olanzapine is superior to placebo at preventing postdischarge nausea and vomiting. METHODS: In a single-center, double-blind, randomized, placebo-controlled trial, the authors compared a single preoperative dose of olanzapine 10 mg to placebo, in adult female patients 50 years old or less, undergoing ambulatory gynecologic or plastic surgery with general anesthesia. All patients received standard antiemetic prophylaxis with dexamethasone and ondansetron. The primary composite outcome was nausea and/or vomiting in the 24 h after discharge. Secondary outcomes included severe nausea, vomiting, and side effects. RESULTS: A total of 140 patients were randomized and evaluable. The primary outcome occurred in 26 of 69 patients (38%) in the placebo group and in 10 of 71 patients (14%) in the olanzapine group (relative risk, 0.37; 95% CI, 0.20 to 0.72; P = 0.003). Severe nausea occurred in 14 patients (20%) in the placebo group and 4 patients (6%) in the olanzapine group (relative risk, 0.28; 95% CI, 0.10 to 0.80). Vomiting occurred in eight patients (12%) in the placebo group and two patients (3%) in the olanzapine group (relative risk, 0.24; 95% CI, 0.05 to 1.10). The median score for sedation (scale 0 to 10, with 10 being highest) in the 24 h after discharge was 4 (interquartile range, 2 to 7) in the placebo group and 6 (interquartile range, 3 to 8) in the olanzapine group (P = 0.023). CONCLUSIONS: When combined with ondansetron and dexamethasone, the addition of olanzapine relative to placebo decreased the risk of nausea and/or vomiting in the 24 hafter discharge from ambulatory surgery by about 60% with a slight increase in reported sedation.

Resident simulation training improves operative time of the retropubic midurethral sling procedure for stress incontinence.

INTRODUCTION AND HYPOTHESIS: Our aim was to assess whether immediate preoperative resident simulation training decreases operative time and improves resident proficiency when performing a retropubic midurethral sling (MUS) procedure. METHODS: This prospective cohort study took place over 8 months at the Icahn School of Medicine, New York, USA. During the first 4 months, all retropubic MUS procedures were performed by residents who underwent immediate preoperative simulation training. The cases completed during the following 4 months were performed by residents who had not received preoperative simulation training. During the 8-month period, residents completed self-assessment questionnaires upon completion of the surgery and attendings evaluated the residents using the Objective Structured Assessment of Technical Skills (OSATS) global rating scale. Operative time between the two periods were compared using two-sample Student's t test. Comparative analysis between groups was performed based on the OSATS scores using the Wilcoxon rank-sum nonparametric test. RESULTS: There were 22 cases in the simulation group (SG) and 20 in the no simulation group (NSG). SG mean operative time was 12.6 min and NSG mean operative time was 14.6 min (p = 0.12). The SG mean OSATS score was 30.4 versus NSG of 27.8 (p < 0.001). CONCLUSIONS: This study demonstrates that preoperative simulation significantly improves operative performance of the retropubic MUS procedure among residents and also improves their confidence in the operating room. There was a decrease in mean operative time of 2 min in the SG, but the difference was not statistically significant. This data is consistent in demonstrating improved surgical performance and resident confidence with simulation training.

Comparison of the Memory Foam Pad Versus the Bean Bag with Shoulder Braces in Preventing Patient Displacement during Gynecologic Laparoscopic Surgery.

STUDY OBJECTIVE: To compare the amount of patient displacement when a memory foam pad is used versus a bean bag with shoulder braces. The secondary aim was to evaluate for postoperative extremity symptoms including pain, numbness, and weakness. DESIGN: A prospective randomized pilot study (Canadian Task Force classification I). SETTING: A single academic institution. PATIENTS: Women ≥18 years of age undergoing laparoscopic or robotic gynecologic surgery. INTERVENTIONS: Patients were randomized to be positioned on the memory foam pad (group A) or the bean bag with shoulder braces (group B) preoperatively. The patients' positions were measured before and after the procedure, and the displacement was recorded. Patients were followed postoperatively and questioned regarding upper extremity or lower extremity weakness, numbness, and pain. Demographic characteristics were collected using the electronic medical record. MEASUREMENTS AND MAIN RESULTS: Forty-three patients were included in the study (22 in group A and 21 in group B). The demographic and intraoperative characteristics of the patients were similar in both groups. The patients in group A moved a mean distance of 3.80 ± 3.32 cm, whereas those in group B moved a mean distance of 1.07 ± 1.93 cm (p = .002). A Pearson correlation coefficient did not yield a correlation between patient displacement and age, body mass index, length of surgery, or pathology weight. In group A, 2 patients had lower extremity numbness, and 1 patient had upper extremity numbness. In group B, 1 patient had upper extremity pain, and 1 patient had both upper and lower extremity numbness. These patients had complete resolution of their symptoms within the first 2 weeks postoperatively, with the exception of 1 patient in group A whose lower extremity numbness resolved 3 months postoperatively. CONCLUSION: Positioning patients on the bean bag with shoulder braces resulted in significantly less displacement during gynecologic laparoscopic surgery when compared with the memory foam pad. All postoperative extremity numbness, weakness, and pain were temporary and resolved completely in our cohort. A larger study would be necessary to determine the true incidence of peripheral nerve injuries because these are rare complications of laparoscopic surgeries.

Urinary sodium is a potent correlate of proteinuria: lessons from the chronic renal insufficiency cohort study.

BACKGROUND: While higher blood pressure is known to increase proteinuria, whether increased dietary sodium as estimated from 24-hour urinary excretion correlates with increased proteinuria in patients with chronic kidney disease (CKD) is not well studied. METHODS: We measured 24-hour urinary sodium, potassium and protein excretion in 3,680 participants in the Chronic Renal Insufficiency Cohort study, to determine the relationship between urinary sodium and potassium and urinary protein excretion in patients with CKD. We stratified our data based on the presence or absence of diabetes given the absence of any data on this relationship and evidence that diabetics had greater urinary protein excretion at nearly every level of urinary sodium excretion. Multiple linear regressions were used with a stepwise inclusion of covariates such as systolic blood pressure, demographics, hemoglobin A1c and type of antihypertensive medications to evaluate the relationship between urinary electrolyte excretion and proteinuria. RESULTS: Our data demonstrated that urinary sodium (+1 SD above the mean), as a univariate variable, explained 12% of the variation in proteinuria (ß = 0.29, p < 0.0001), with rising urinary sodium excretion associated with increasing proteinuria. The significance of that relationship was only partially attenuated with adjustment for demographic and clinical factors and the addition of 24-hour urinary potassium to the model (ß = 0.13, R(2) = 0.35, p < 0.0001). CONCLUSIONS: An understanding of the relationship between these clinical factors and dietary sodium may allow a more tailored approach for dietary salt restriction in patients with CKD.

Factors associated with depressive symptoms and use of antidepressant medications among participants in the Chronic Renal Insufficiency Cohort (CRIC) and Hispanic-CRIC Studies.

BACKGROUND: Depressive symptoms are correlated with poor health outcomes in adults with chronic kidney disease (CKD). The prevalence, severity, and treatment of depressive symptoms and potential risk factors, including level of kidney function, in diverse populations with CKD have not been well studied. STUDY DESIGN: Cross-sectional analysis. SETTINGS & PARTICIPANTS: Participants at enrollment into the Chronic Renal Insufficiency Cohort (CRIC) and Hispanic-CRIC (H-CRIC) Studies. CRIC enrolled Hispanics and non-Hispanics at 7 centers in 2003-2007, and H-CRIC enrolled Hispanics at the University of Illinois in 2005-2008. MEASUREMENT: Depressive symptoms measured by Beck Depression Inventory (BDI). PREDICTORS: Demographic and clinical factors. OUTCOMES: Elevated depressive symptoms (BDI score ≥11) and antidepressant medication use. RESULTS: Of 3,853 participants, 27.4% had evidence of elevated depressive symptoms and 18.2% were using antidepressant medications; 31.0% of persons with elevated depressive symptoms were using antidepressants. The prevalence of elevated depressive symptoms varied by level of kidney function: 23.6% for participants with estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m(2) and 33.8% of those with eGFR <30 mL/min/1.73 m(2). Lower eGFR (OR per 10-mL/min/1.73 m(2) decrease, 1.10; 95% CI, 1.04-1.17), and non-Hispanic black race (OR, 1.42; 95% CI, 1.16-1.74) were each associated with increased odds of elevated depressive symptoms after controlling for other factors. In regression analyses incorporating BDI score, whereas female sex was associated with greater odds of antidepressant use, Hispanic ethnicity, non-Hispanic black race, and higher urine albumin levels were associated with decreased odds of antidepressant use (P < 0.05 for each). LIMITATIONS: Absence of clinical diagnosis of depression and use of nonpharmacologic treatments. CONCLUSIONS: Although elevated depressive symptoms were common in individuals with CKD, use of antidepressant medications is low. Individuals of racial and ethnic minority background and with more advanced CKD had a greater burden of elevated depressive symptoms and lower use of antidepressant medications.

Hemodynamic correlates of proteinuria in chronic kidney disease.

BACKGROUND AND OBJECTIVES: Brachial artery measures of BP are associated with increasing degrees of proteinuria. Whether central measures of BP or vascular stiffness are associated with increased risk of proteinuria in patients with chronic kidney disease (CKD) is unknown. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Measurements of central and brachial artery BP, and aortic pulse wave velocity (PWV) were performed in a cross-sectional cohort of patients with CKD (n = 2144) from the Chronic Renal Insufficiency Cohort (CRIC) study to determine factors which predict increased risk of proteinuria. Multivariate analysis stratified by diabetes included age, ethnicity, gender, estimated glomerular filtration rate (GFR), waistline, smoking, heart rate, and medications to evaluate the relationship of hemodynamic factors and proteinuria. RESULTS: Brachial artery systolic BP (SBP) was important as an explanatory factor for variations in proteinuria among both diabetics (R(2) = 0.40, P < 0.0001) and non diabetics (R(2) = 0.38, P < 0.001). Measures of peripheral pulse pressure (PP), central SBP, and central pulse pressure added little to the explained variation in proteinuria beyond brachial artery SBP, whereas PWV as a measure of vascular stiffness incrementally accounted for a significant portion of variation in proteinuria beyond that explained by brachial artery SBP in diabetics (R(2) = 0.42, P < 0.001) but not non diabetics. CONCLUSIONS: Brachial artery SBP and PWV are both associated with variations in proteinuria in patients with CKD.

Relationship of estimated GFR and coronary artery calcification in the CRIC (Chronic Renal Insufficiency Cohort) Study.

BACKGROUND: Coronary artery calcification (CAC) is associated with increased mortality risk in the general population. Although individuals with chronic kidney disease (CKD) are at markedly increased mortality risk, the incidence, prevalence, and prognosis of CAC in CKD are not well understood. STUDY DESIGN: Cross-sectional observational study. SETTING & PARTICIPANTS: Analysis of 1,908 participants who underwent coronary calcium scanning as part of the multiethnic CRIC (Chronic Renal Insufficiency Cohort) Study. PREDICTOR: Estimated glomerular filtration rate (eGFR) computed using the Modification of Diet in Renal Disease (MDRD) Study equation, stratified by race, sex, and diabetic status. eGFR was treated as a continuous and a categorical variable compared with the reference value of >60 mL/min/1.73 m(2). MEASUREMENTS: CAC detected using computed tomography (CT) using either an Imatron C-300 electron beam computed tomography (CT) scanner or multidetector CT scanner. CAC was computed using Agatston score as a categorical variable. Analyses were performed using ordinal logistic regression. RESULTS: We found a strong and graded relationship between lower eGFR and increasing CAC. In unadjusted models, ORs increased from 1.68 (95% CI, 1.23-2.31) for eGFR of 50-59 mL/min/1.73 m(2) to 2.82 (95% CI, 2.06-3.85) for eGFR <30 mL/min/1.73 m(2). Multivariable adjustment only partially attenuated the results (OR, 1.53; 95% CI, 1.07-2.20) for eGFR <30 mL/min/1.73 m(2). LIMITATIONS: Use of eGFR rather than measured GFR. CONCLUSIONS: We showed a graded relationship between severity of CKD and CAC independent of traditional risk factors. These findings support recent guidelines that state that if vascular calcification is present, it should be considered as a complementary component to be included in the decision making required for individualizing CKD treatment.

CKD in Hispanics: Baseline characteristics from the CRIC (Chronic Renal Insufficiency Cohort) and Hispanic-CRIC Studies.

BACKGROUND: Little is known regarding chronic kidney disease (CKD) in Hispanics. We compared baseline characteristics of Hispanic participants in the Chronic Renal Insufficiency Cohort (CRIC) and Hispanic-CRIC (H-CRIC) Studies with non-Hispanic CRIC participants. STUDY DESIGN: Cross-sectional analysis. SETTING & PARTICIPANTS: Participants were aged 21-74 years with CKD using age-based estimated glomerular filtration rate (eGFR) at enrollment into the CRIC/H-CRIC Studies. H-CRIC included Hispanics recruited at the University of Illinois in 2005-2008, whereas CRIC included Hispanics and non-Hispanics recruited at 7 clinical centers in 2003-2007. FACTOR: Race/ethnicity. OUTCOMES: Blood pressure, angiotensin-converting enzyme (ACE)-inhibitor/angiotensin receptor blocker (ARB) use, and CKD-associated complications. MEASUREMENTS: Demographic characteristics, laboratory data, blood pressure, and medications were assessed using standard techniques and protocols. RESULTS: Of H-CRIC/CRIC participants, 497 were Hispanic, 1,650 were non-Hispanic black, and 1,638 were non-Hispanic white. Low income and educational attainment were nearly twice as prevalent in Hispanics compared with non-Hispanics (P < 0.01). Hispanics had self-reported diabetes (67%) more frequently than non-Hispanic blacks (51%) and whites (40%; P < 0.01). Blood pressure >130/80 mm Hg was more common in Hispanics (62%) than blacks (57%) and whites (35%; P < 0.05), and abnormalities in hematologic, metabolic, and bone metabolism parameters were more prevalent in Hispanics (P < 0.05), even after stratifying by entry eGFR. Hispanics had the lowest use of ACE inhibitors/ARBs among the high-risk subgroups, including participants with diabetes, proteinuria, and blood pressure >130/80 mm Hg. Mean eGFR was lower in Hispanics (39.6 mL/min/1.73 m(2)) than in blacks (43.7 mL/min/1.73 m(2)) and whites (46.2 mL/min/1.73 m(2)), whereas median proteinuria was higher in Hispanics (protein excretion, 0.72 g/d) than in blacks (0.24 g/d) and whites (0.12 g/d; P < 0.01). LIMITATIONS: Generalizability; observed associations limited by residual bias and confounding. CONCLUSIONS: Hispanics with CKD in the CRIC/H-CRIC Studies are disproportionately burdened with lower socioeconomic status, more frequent diabetes mellitus, less ACE-inhibitor/ARB use, worse blood pressure control, and more severe CKD and associated complications than their non-Hispanic counterparts.

Diuretics, calciuria and secondary hyperparathyroidism in the Chronic Renal Insufficiency Cohort.

BACKGROUND: Secondary hyperparathyroidism is a common complication of chronic kidney disease (CKD) that is associated with bone disease, cardiovascular disease and death. Pathophysiological factors that maintain secondary hyperparathyroidism in advanced CKD are well-known, but early mechanisms of the disease that can be targeted for its primary prevention are poorly understood. Diuretics are widely used to control volume status and blood pressure in CKD patients but are also known to have important effects on renal calcium handling, which we hypothesized could alter the risk of secondary hyperparathyroidism. METHODS: We examined the relationship of diuretic treatment with urinary calcium excretion, parathyroid hormone (PTH) levels and prevalence of secondary hyperparathyroidism (PTH ≥ 65 pg/mL) in a cross-sectional study of 3616 CKD patients in the Chronic Renal Insufficiency Cohort. RESULTS: Compared with no diuretics, treatment with loop diuretics was independently associated with higher adjusted urinary calcium (55.0 versus 39.6 mg/day; P < 0.001), higher adjusted PTH [67.9, 95% confidence interval (CI) 65.2-70.7 pg/mL, versus 52.8, 95% CI 51.1-54.6 pg/mL, P < 0.001] and greater odds of secondary hyperparathyroidism (odds ratio 2.1; 95% CI 1.7-2.6). Thiazide monotherapy was associated with lower calciuria (25.5 versus 39.6 mg/day; P < 0.001) but only modestly lower PTH levels (50.0, 95% CI 47.8-52.3, versus 520.8, 95% CI 51.1-54.6 pg/mL, P = 0.04) compared with no diuretics. However, coadministration of thiazide and loop diuretics was associated with blunted urinary calcium (30.3 versus 55.0 mg/day; P <0.001) and odds of hyperparathyroidism (odds ratio 1.3 versus 2.1; P for interaction = 0.05) compared with loop diuretics alone. CONCLUSIONS: Loop diuretic use was associated with greater calciuria, PTH levels and odds of secondary hyperparathyroidism compared to no treatment. These associations were attenuated in patients who were coadministered thiazides. Diuretic choice is a potentially modifiable determinant of secondary hyperparathyroidism in CKD.