Medication Intervention for Chronic Kidney Disease Patients Transitioning from Hospital to Home: Study Design and Baseline Characteristics.

BACKGROUND: The hospital readmission rate in the population with chronic kidney disease (CKD) is high and strategies to reduce this risk are urgently needed. METHODS: The CKD-Medication Intervention Trial (CKD-MIT; www.clinicaltrials.gov; NCTO1459770) is a single-blind (investigators), randomized, clinical trial conducted at Providence Health Care in Spokane, Washington. Study participants are hospitalized patients with CKD stages 3-5 (not treated with kidney replacement therapy) and acute illness. The study intervention is a pharmacist-led, home-based, medication management intervention delivered within 7 days after hospital discharge. The primary outcome is a composite of hospital readmissions and visits to emergency departments and urgent care centers for 90 days following hospital discharge. Secondary outcomes are achievements of guideline-based targets for CKD risk factors and complications. RESULTS: Enrollment began in February 2012 and ended in May 2015. At baseline, the age of participants was 69 ± 11 years (mean ± SD), 50% (77 of 155) were women, 83% (117 of 141) had hypertension and 56% (79 of 141) had diabetes. At baseline, the estimated glomerular filtration rate was 41 ± 14 ml/min/1.73 m2 and urine albumin-to-creatinine ratio was 43 mg/g (interquartile range 8-528 mg/g). The most frequent diagnosis category for the index hospital admission was cardiovascular diseases at 34% (53 of 155), but the most common single diagnosis for admission was community-acquired acute kidney injury at 10% (16 of 155). CONCLUSION: Participants in CKD-MIT are typical of acutely ill hospitalized patients with CKD. A medication management intervention after hospital discharge is under study to reduce post-hospitalization acute care utilization and to improve CKD management.

Dietary amino acids and blood pressure: a cohort study of patients with cardiovascular disease.

BACKGROUND: Dietary protein has been variably reported to either lower or raise blood pressure. The purpose of this study was to determine whether intakes of specific amino acids differentially associate with blood pressure. STUDY DESIGN: Observational cohort study by secondary analysis of clinical trial data. SETTING & PARTICIPANTS: Study of low-fat versus Mediterranean-style diets in patients with prevalent cardiovascular disease. PREDICTOR: Dietary amino acids. OUTCOMES: Systolic and diastolic blood pressure. MEASUREMENTS: Dietary nutrients and cardiovascular risk factors were assessed at baseline, 3 and 6 months, and then every 6 months for 2 years. RESULTS: Baseline blood pressure was 119 ± 16 (SD)/72 ± 10 (SD) mm Hg (n = 92) and dietary protein intake was 80 ± 31 g/d. Independent amino acid variables (quartiles of intake) were analyzed by generalized estimating equation models with prespecified covariates for time-varying systolic and diastolic blood pressure. The odds of each 1-SD higher systolic or diastolic blood pressure (ie, 16 and 10 mm Hg, respectively) were increased per quartile of intake for methionine (ORs of 1.29 [95% CI, 1.14-1.46] and 1.21 [95% CI, 1.05-1.39], respectively) and alanine (ORs of 1.17 [95% CI, 1.05-1.30] and 1.22 [95% CI, 1.07-1.38], respectively). Quartiles of intake for threonine (ORs of 0.84 [95% CI, 0.74-0.96] and 0.87 [95% CI, 0.75-1.01], respectively) and histidine (ORs of 0.92 [95% CI, 0.86-1.00] and 0.89 [95% CI, 0.82-0.97], respectively) had inverse associations with the same degree of difference in blood pressure. LIMITATIONS: Modest sample-size biases toward the chance of false-negative results; potential for residual confounding; colinearity between amino acids may obscure relevant relationships to blood pressure; associational findings do not establish causality. CONCLUSIONS: Intakes of methionine and alanine were associated positively with higher blood pressure, whereas intakes of threonine and histidine had inverse associations. These amino acids merit further study for advancing dietary approaches to blood pressure reduction.

Modulation of advanced glycation end products by candesartan in patients with diabetic kidney disease--a dose-response relationship study.

Advanced glycation end products (AGEs) are proinflammatory mediators implicated in the pathogenesis of diabetic kidney disease (DKD). In this study, dose-dependent effects of angiotensin receptor blockade on urinary AGEs were evaluated in patients with DKD. Patients with type 2 diabetes and proteinuria ≥500 mg/d (n = 11) were compared with diabetic controls without DKD (n = 10) and normal controls (n = 11). After a 2-week washout period, DKD participants were treated with candesartan doses progressively increasing from 8, 16, 32, to 64 mg/d every 3 weeks for a total of 12 weeks. Other antihypertensive agents were adjusted to maintain stable blood pressure. At baseline and after each dosing period, blood pressure measurements and 24-hour urine collections were obtained. Urinary carboxymethyl lysine, an AGE biomarker, was reduced over the 12-week dose escalation protocol (r = 0.38, P = 0.01) in DKD participants. Creatinine clearance increased slightly, but albuminuria was unaffected by candesartan administration. Baseline urinary transforming growth factor-ß1 excretion was lower in DKD participants than in controls and did not change during the study period. Reducing kidney exposure to AGEs may be a mechanism of protection by angiotensin receptor blockade in DKD. AGEs may also impact the diabetic kidney through mechanisms independent of transforming growth factor-ß1.

Medication use, renin-angiotensin system inhibitors, and acute care utilization after hospitalization in patients with chronic kidney disease.

OBJECTIVES: The aims of this secondary analysis were to: (a) characterize medication use following hospital discharge for patients with chronic kidney disease (CKD), and (b) investigate relationships of medication use with the primary composite outcome of acute care utilization 90 days after hospitalization. METHODS: The CKD-Medication Intervention Trial (CKD-MIT) enrolled acutely ill hospitalized patients with CKD stages 3-5 not dialyzed (CKD 3-5 ND). In this post hoc analysis, data for medication use were characterized, and the relationship of medication use with the primary outcome was evaluated using Cox proportional hazards models. RESULTS: Participants were taking a mean of 12.6 (standard deviation=5.1) medications, including medications from a wide variety of medication classes. Nearly half of study participants were taking angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARB). ACE inhibitor/ARB use was associated with decreased risk of the primary outcome (hazard ratio=0.51; 95% confidence interval 0.28-0.95; p=0.03) after adjustment for baseline estimated glomerular filtration rate, age, sex, race, blood pressure, albuminuria, and potential nephrotoxin use. CONCLUSIONS: A large number, variety, and complexity of medications were used by hospitalized patients with CKD 3-5 ND. ACE inhibitor or ARB use at hospital discharge was associated with a decreased risk of 90-day acute care utilization.

Should albuminuria be a focus of antihypertensive therapy goals?

Albuminuria has been recognized as a risk marker for both chronic kidney disease and cardiovascular disease in large observational cohorts. In addition, post hoc analyses of many large randomized trials have found a positive relationship between albu-minuria and adverse renal and cardiovascular outcomes, leading some to suggest that albuminuria may be a potential therapeutic target for antihypertensive treatment. However, direct clinical evidence linking albuminuria reduction to reduction in adverse renal and cardiovascular events is scarce. This paper reviews the evidence in the current literature to address whether albuminuria can be used as a credible predictor of risk for chronic kidney disease and cardiovascular disease and also reviews the clinical trial evidence to appraise the prospect of using albuminuria as a therapeutic target to prevent adverse renal and cardiovascular events.

Comparison of low-fat versus Mediterranean-style dietary intervention after first myocardial infarction (from The Heart Institute of Spokane Diet Intervention and Evaluation Trial).

Whether a Mediterranean-style diet reduces cardiovascular events and mortality more than a low-fat diet is uncertain. The objectives of this study were to actively compare low-fat and Mediterranean-style diets after first myocardial infarction (MI) in a randomized, controlled clinical trial and to compare dietary intervention per se with usual care in a case-control analysis. First MI survivors were randomized to a low-fat (n = 50) or Mediterranean-style (n = 51) diet. The 2 diets were low in saturated fat (< or =7% kcal) and cholesterol (< or =200 mg/day); the Mediterranean-style diet was distinguished by greater omega-3 fat intake (>0.75% kcal). Participants received individual dietary counseling sessions, 2 within the first month and again at 3, 6, 12, 18, and 24 months, along with 6 group sessions. Combined dietary intervention groups (cases, n = 101) were compared with a usual-care group (controls, n = 101) matched for age, gender, MI type and treatment, and status of diabetes mellitus and hypertension. Primary-outcome-free survival (a composite of all-cause and cardiac deaths, MI, hospital admissions for heart failure, unstable angina pectoris, or stroke) did not differ between low-fat (42 of 50) and Mediterranean-style (43 of 51) diet groups over a median follow-up period of 46 months (range 18 to 72; log-rank p = 0.81). Patients receiving dietary intervention had better primary-outcome-free survival (85 of 101) than usual-care controls (61 of 101) (log-rank p <0.001), with unadjusted and adjusted odds ratios of 0.33 (95% confidence interval 0.18 to 0.60, p <0.001) and 0.28 (95% confidence interval 0.13 to 0.63, p = 0.002), respectively. In conclusion, active intervention with either a low-fat or a Mediterranean-style diet similarly and significantly benefits overall and cardiovascular-event-free survival after MI.

Medication Therapy Management after Hospitalization in CKD: A Randomized Clinical Trial.

BACKGROUND AND OBJECTIVES: CKD is characterized by remarkably high hospitalization and readmission rates. Our study aim was to test a medication therapy management intervention to reduce subsequent acute care utilization. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: The CKD Medication Intervention Trial was a single-blind (investigators), randomized clinical trial conducted at Providence Health Care in Spokane, Washington. Patients with CKD stages 3-5 not treated by dialysis who were hospitalized for acute illness were recruited. The intervention was designed to improve posthospitalization care by medication therapy management. A pharmacist delivered the intervention as a single home visit within 7 days of discharge. The intervention included these fundamental elements: comprehensive medication review, medication action plan, and a personal medication list. The primary outcome was a composite of acute care utilization (hospital readmissions and emergency department and urgent care visits) for 90 days after hospitalization. RESULTS: Baseline characteristics of participants (n=141) included the following: age, 69±11 (mean±SD) years old; women, 48% (67 of 141); diabetes, 56% (79 of 141); hypertension, 83% (117 of 141); eGFR, 41±14 ml/min per 1.73 m2 (serum creatinine-based Chronic Kidney Disease Epidemiology Collaboration equation); and urine albumin-to-creatinine ratio median, 43 mg/g (interquartile range, 8-528) creatinine. The most common primary diagnoses for hospitalization were the following: cardiovascular events, 36% (51 of 141); infections, 18% (26 of 141); and kidney diseases, 12% (17 of 141). The primary outcome occurred in 32 of 72 (44%) of the medication intervention group and 28 of 69 (41%) of those in usual care (log rank P=0.72). For only hospital readmission, the rate was 19 of 72 (26%) in the medication intervention group and 18 of 69 (26%) in the usual care group (log rank P=0.95). There was no between-group difference in achievement of guideline-based goals for use of renin-angiotensin system inhibition or for BP, hemoglobin, phosphorus, or parathyroid hormone. CONCLUSIONS: Acute care utilization after hospitalization was not reduced by a pharmacist-led medication therapy management intervention at the transition from hospital to home.

Implications of chronic kidney disease for dietary treatment in cardiovascular disease.

Chronic kidney disease (CKD) often accompanies cardiovascular disease (CVD). Trends foretelling a greater burden of CKD and CVD are largely a result of increasing frequencies of obesity, hypertension, and diabetes. Nutritional therapy occupies a critical role in reducing risk factors and preventing progressive damage to the kidneys and heart. Nutritional assessment and treatment should take into account both health concerns. This review examines several diet components and eating styles for efficacy in the treatment of these conditions. A variety of dietary regimens claim to provide health benefits, but rigorous scientific validation of long-term efficacy is frequently lacking. An urgent need exists for eating styles that reduce risk of chronic diseases and that are acceptable and achievable in free-living populations. We describe our ongoing study, a randomized controlled trial comparing the American Heart Association Step II diet and a Mediterranean diet, in survivors of a first myocardial infarction. The primary end point is a composite of mortality and major CVD events. Because many in this population have CKD, indicators of kidney damage and function are prespecified secondary end points. Results of this trial should provide insight into optimal dietary interventions for persons with both CVD and CKD.

Clinical evidence for the influence of uric acid on hypertension, cardiovascular disease, and kidney disease: a statistical modeling perspective.

This article critically evaluates the clinical evidence regarding the influence of uric acid on hypertension, cardiovascular disease, and kidney disease. Data on these relationships are largely observational and exceedingly complex. The complexity is owing to indirect and direct relations, and bidirectional influences, simultaneously operating on multiple outcomes. Limitations of previous analyses include inadequate statistical methods using only bivariate correlations or poorly specified multiple regression models. As a result, great controversy developed as to whether uric acid is an independent predictor of important outcomes. An example of such analytic limitations is including hypertension as an independent variable, together with uric acid, in a multivariate model for predicting cardiovascular disease. Hypertension may predict significant variance in cardiovascular disease, but the contribution of uric acid may not be recognized if uric acid exerts its influence indirectly through hypertension. Path analysis, which can model direct and indirect influences on outcomes simultaneously, would address this substantive question. Studies of uric acid in relation to hypertension, cardiovascular disease, and kidney disease using a path-analytic approach would help specify such conditions as well as optimize design of clinical trials to determine if decreasing uric acid levels improves outcomes.

Service use among patients with schizophrenia in psychoeducational multiple-family group treatment.

OBJECTIVES: Outpatient and inpatient mental health service outcomes for outpatients with schizophrenia or schizoaffective disorder who received psychoeducational multiple-family group treatment were compared with outcomes for similar patients who received standard care. METHODS: A total of 106 outpatients with schizophrenia or schizoaffective disorder who were receiving services from a large community mental health center were randomly assigned to receive standard care or standard care plus multiple-family group treatment. The two-year multiple-family intervention consisted of weekly group sessions designed to educate patients and their family members about the biological basis of mental illness and treatment, to improve illness management and coping skills, and to provide social support. The group sessions were conducted by two clinicians using a standardized protocol. Each multiple-family group included five to eight families and consumers. Service records for the year before and after random assignment to the study groups were examined in an intent-to-treat analysis. RESULTS: During the year after random assignment to study groups, multiple-family group treatment was associated with a lower rate of psychiatric hospitalization than standard care. It was only marginally associated with lower use of crisis services, and it was not associated with the amount of outpatient service time. CONCLUSIONS: The findings suggest that implementation of multiple-family group treatment in a capitated community mental health setting improves hospitalization outcomes without increasing the overall volume of outpatient mental health services.

Impact of multiple-family groups for outpatients with schizophrenia on caregivers' distress and resources.

OBJECTIVE: The objective of this study was to evaluate the effects of multiple-family group treatment on distress and psychosocial resources among family caregivers of persons with schizophrenia. METHODS: A total of 97 consumers with schizophrenia or another psychotic disorder and their caregivers were randomly assigned to receive multiple-family group treatment (N=53) or standard psychiatric outpatient care (N=44). Reliable and valid measures were used to assess caregivers' distress, caregivers' resources, and consumers' clinical status. RESULTS: After consumers' clinical status and baseline rates of caregivers' distress and caregivers' resources were controlled for, the caregivers of consumers who received multiple-family group treatment experienced greater reductions in distress but no increases in resources compared with caregivers of consumers who received standard psychiatric care. CONCLUSIONS: Multiple-family group treatment reduced caregivers' distress but did not increase caregivers' resources relative to standard psychiatric care.

Relations among whole blood serotonin and sex, age, diet, and social status in Macaca nemestrina.

Whole blood serotonin (WBS) determinations were made in 56 pigtailed macaques (Macaca nemestrina) with approximately equal numbers in three age groups: young-adult (4-5 years), middle-aged (13-14 years), and old (over 18 years). The animals were housed in ten living groups with one female and male of each age group in each living group. Half of the groups were fed a diet high in lipid, cholesterol, simple sugars, and sodium; the other half received a restricted diet. Three determinations per animal showed WBS levels to be stable at two times of day and at a 1-week interval, and individual differences were stable over several months' time. The mean WBS concentrations in M. nemestrina were found to be considerably higher than those reported for other species. The mean levels in females were almost 25% higher than in males. No significant effects of age, diet, or dominance status were detected.

The minimum data set: predicting malnutrition in newly admitted nursing home residents.

The purpose of this study was to describe the prevalence of protein-calorie malnutrition (PCM) among newly admitted elderly nursing home residents and identify the most significant predictors of PCM using Minimum Data Set (MDS) variables. Using a cross-sectional design, the authors studied 306 nursing home residents. Malnutrition risk factors found on the MDS were measured for each resident. Overall, 118 (38.6%) residents met the Nutrition Screening Initiative Guidelines for PCM. MDS variables found to be significant predictors were weight loss, leaves 25% or more offood uneaten at most meals, psychiatric/mood diagnoses, deteriorated ability to participate in activities of daily living. and older age. Three additional variables (antidepressant use, diuretic use, therapeutic diet) were found to be protective-residents with these variables were more likely to have a normal body mass index. MDS data provide an opportunity for early identification of residents who are at riskfor PCM and accompanying morbidity.

Efficient driver drowsiness detection at moderate levels of drowsiness.

Previous research on driver drowsiness detection has focused primarily on lane deviation metrics and high levels of fatigue. The present research sought to develop a method for detecting driver drowsiness at more moderate levels of fatigue, well before accident risk is imminent. Eighty-seven different driver drowsiness detection metrics proposed in the literature were evaluated in two simulated shift work studies with high-fidelity simulator driving in a controlled laboratory environment. Twenty-nine participants were subjected to a night shift condition, which resulted in moderate levels of fatigue; 12 participants were in a day shift condition, which served as control. Ten simulated work days in the study design each included four 30-min driving sessions, during which participants drove a standardized scenario of rural highways. Ten straight and uneventful road segments in each driving session were designated to extract the 87 different driving metrics being evaluated. The dimensionality of the overall data set across all participants, all driving sessions and all road segments was reduced with principal component analysis, which revealed that there were two dominant dimensions: measures of steering wheel variability and measures of lateral lane position variability. The latter correlated most with an independent measure of fatigue, namely performance on a psychomotor vigilance test administered prior to each drive. We replicated our findings across eight curved road segments used for validation in each driving session. Furthermore, we showed that lateral lane position variability could be derived from measured changes in steering wheel angle through a transfer function, reflecting how steering wheel movements change vehicle heading in accordance with the forces acting on the vehicle and the road. This is important given that traditional video-based lane tracking technology is prone to data loss when lane markers are missing, when weather conditions are bad, or in darkness. Our research findings indicated that steering wheel variability provides a basis for developing a cost-effective and easy-to-install alternative technology for in-vehicle driver drowsiness detection at moderate levels of fatigue.

Randomized controlled trial of contingency management for stimulant use in community mental health patients with serious mental illness.

OBJECTIVE: The primary objective of this study was to determine whether contingency management was associated with increased abstinence from stimulant drug use in stimulant-dependent patients with serious mental illness treated in a community mental health center. Secondary objectives were to determine whether contingency management was associated with reductions in use of other substances, psychiatric symptoms, HIV risk behavior, and inpatient service utilization. METHOD: A randomized controlled design was used to compare outcomes of 176 outpatients with serious mental illness and stimulant dependence. Participants were randomly assigned to receive 3 months of contingency management for stimulant abstinence plus treatment as usual or treatment as usual with reinforcement for study participation only. Urine drug tests and self report, clinician-report, and service utilization outcomes were assessed during the 3-month treatment period and the 3-month follow-up period. RESULTS: Although participants in the contingency management condition were significantly less likely to complete the treatment period than those assigned to the control condition (42% compared with 65%), they were 2.4 times (95% CI=1.9­3.0)more likely to submit a stimulant-negative urine test during treatment. Compared with participants in the control condition,they had significantly lower levels of alcohol use, injection drug use, and psychiatric symptoms and were one-fifth as likely as those assigned to the control condition to be admitted for psychiatric hospitalization during treatment. They also reported significantly fewer days of stimulant drug use during the 3-month follow-up. CONCLUSIONS: When added to treatment as usual, contingency management is associated with large reductions in stimulant,injection drug, and alcohol use.Reductions in psychiatric symptoms and hospitalizations are important secondary benefits.

Predicting drug court outcome among amphetamine-using participants.

Amphetamine use and abuse carry with it substantial social costs. Although there is a perception that amphetamine users are more difficult to treat than other substance users, drug courts have been used to effectively address drug-related crimes and hold the potential to lessen the impact of amphetamine abuse through efficacious treatment and rehabilitation. The objective of this study was to identify predictors of drug court outcome among amphetamine-using participants. A drug court database was obtained (N = 540) and amphetamine-using participants (n= 341) identified. Multivariate binary regression models run for the amphetamine-using participants identified being employed and being a parent as predictive of successful completion of the program, whereas being sanctioned to jail during the program was inversely related to program completion.

Risks of subsequent hospitalization and death in patients with kidney disease.

BACKGROUND AND OBJECTIVES: Rates of hospitalization are known to be high in patients with kidney disease. However, ongoing risks of subsequent hospitalization and mortality are uncertain. The primary objective was to evaluate patients with kidney disease for long-term risks of subsequent hospitalization, including admissions resulting in death. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Patients hospitalized in Washington State between April of 2006 and December of 2008 who survived to discharge (n=676,343) were classified by International Classification of Disease codes into CKD (n=27,870), dialysis (n=6131), kidney transplant (n=1100), and reference (n=641,242) cohorts. Cox proportional hazard models controlling for age, sex, payer, comorbidity, previous hospitalization, primary diagnosis category, and length of stay were conducted for time to event analyses. RESULTS: Compared with the reference cohort, risks for subsequent hospitalization were increased in the CKD (hazard ratio=1.20, 99% confidence interval=1.18-1.23, P<0.001), dialysis (hazard ratio=1.76, 99% confidence interval=1.69-1.83, P<0.001), and kidney transplant (hazard ratio=1.85, 99% confidence interval=1.68-2.03, P<0.001) cohorts, with a mean follow-up time of 29 months. Similarly, risks for fatal hospitalization were increased for patients in the CKD (hazard ratio=1.41, 99% confidence interval=1.34-1.49, P<0.001), dialysis (hazard ratio=3.04, 99% confidence interval=2.78-3.31, P<0.001), and kidney transplant (hazard ratio=2.25, 99% confidence interval=1.67-3.03, P<0.001) cohorts. Risks for hospitalization and fatal hospitalization increased in a graded manner by CKD stage. CONCLUSIONS: Risks of subsequent hospitalization, including admission resulting in death, among patients with kidney disease were substantially increased in a large statewide population. Patients with kidney disease should be a focus of efforts to reduce hospitalizations and mortality.

Longitudinal relationships among coronary artery calcification, serum phosphorus, and kidney function.

BACKGROUND AND OBJECTIVES: Coronary artery calcification (CAC) is common in advanced chronic kidney disease (CKD), yet its onset and time course are uncertain. The study objective was to assess longitudinal relationships among CAC, kidney function, and traditional and putative cardiovascular disease (CVD) risk factors. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This is a prospective cohort analysis from the Spokane Heart Study, a long-term observational study of community-dwelling adults who were assessed every 2 yr for CAC (electron-beam computed tomography), CVD risk factors, and laboratory testing. Estimated GFR (eGFR) was determined by the reexpressed Modification of Diet in Renal Disease equation. RESULTS: CAC was present in 28% (245 of 883) at baseline. After 6 yr, new-onset CAC developed in 33% (122 of 371); severity increased from a median CAC score of 38 to 152 in those with baseline CAC. Neither eGFR (101 +/- 34 versus 104 +/- 31 ml/min per 1.73 m(2), respectively) nor serum phosphorus (3.25 +/- 0.49 versus 3.29 +/- 0.48 mg/dl, respectively) differed by CAC presence or absence at baseline; however, multivariate models (generalized estimating equations for incidence and prevalence) revealed that independent predictors of CAC over time were greater baseline CAC scores, higher serum phosphorus levels, lower eGFR levels, and traditional CVD risk factors. Each 1-mg/dl increase in phosphorus imparted odds ratios for CAC of 1.61 (incidence) and 1.54 (prevalence), risks comparable to traditional CVD risk factors. CONCLUSIONS: CAC becomes more frequent and severe over time. Higher levels of serum phosphorus and reduced kidney function independently predicted CAC.

Effect of vaginal lubricants on sperm motility and chromatin integrity: a prospective comparative study.

OBJECTIVE: To evaluate the effect of vaginal lubricants Pre-Seed, FemGlide, Astroglide, and Replens on human sperm motility and chromatin integrity. DESIGN: Prospective, comparative, in vitro study. SETTING: Andrology laboratory at tertiary care hospital. PATIENT(S): Thirteen normozoospermic donors. INTERVENTION(S): Semen samples from 13 subjects were incubated in human tubal fluid media (HTF) controls and 10% (vol/vol) of Pre-Seed, FemGlide, Astroglide, and Replens lubricants. After 30 minutes, progressive sperm motility was assessed by light microscopy. Semen samples of 12 patients were placed in positive control (HTF), negative control (10% K-Y Jelly lubricant), and 10% vol/vol Pre-Seed and FemGlide lubricants. After 4 hours culture, spermatozoa were analyzed for percent DNA fragmentation index with use of the acridine orange-based sperm chromatin structure assay. MAIN OUTCOME MEASURE(S): Sperm motility and percent DNA fragmentation index. RESULTS: Percent motility did not differ significantly between HTF controls and Pre-Seed, whereas FemGlide, Replens, and Astroglide lubricants demonstrated a significant decrease in motility. There was no significant difference in percent DNA fragmentation index between the HTF controls and Pre-Seed, but a significant decline in sperm chromatin quality occurred with FemGlide and K-Y Jelly. CONCLUSION: Pre-Seed does not cause a significant decrease in progressive sperm motility or chromatin integrity in contrast to other lubricants used by couples.