44 research outputs found
A novel egg white-based solid oral nutritional supplement improves serum albumin and protein intake in patients on peritoneal dialysis: A prospective interventional study
No full textBackground & aims: Protein-energy wasting (PEW) is a major predictor of adverse outcomes in patients undergoing continuous ambulatory peritoneal dialysis (CAPD). Achieving the recommended dietary protein intake remains a significant clinical challenge. This study aimed to evaluate the safety and efficacy of “Egg Bite,” a novel, palatable, solid oral nutritional supplement (ONS) derived from egg white, in improving the nutritional status of CAPD patients. Methods: In this prospective, single-arm interventional trial, 35 CAPD patients with serum albumin ≤ 4.0 g/dL consumed a daily supplement of “Egg Bite” (105 g/day, providing 25.7 g protein and 392 kcal) for 21 consecutive days. The primary outcome was the change in serum albumin. Secondary outcomes included changes in overall dietary intake, anthropometric measures, and key biochemical markers (renal, metabolic, and inflammatory). Assessments were performed at baseline, day 14, and day 21. Results: Thirty-five of 42 enrolled patients (83%) completed the study. Daily supplementation resulted in a significant increase in mean serum albumin from 3.38 ± 0.42 g/dL at baseline to 3.48 ± 0.43 g/dL at day 21 (P = 0.001). Total protein intake rose significantly from 0.9 ± 0.2 g/kg/day to 1.4 ± 0.4 g/kg/day (P < 0.001), successfully meeting guideline recommendations. Energy intake also increased significantly (P < 0.001). No significant changes were observed in body weight or BMI. The supplement was well-tolerated, with non-significant increases in serum potassium and stable hemoglobin levels. Minor but statistically significant increases in BUN and creatinine were noted, consistent with increased protein metabolism. In patients with baseline hypoalbuminemia (n=19), hs-CRP showed a non-significant downward trend from 10.44 to 8.10 mg/dL. Conclusions: Daily supplementation with “Egg Bite,” a novel egg white-based solid ONS, is a safe, well-tolerated, and effective intervention for improving protein-energy status in CAPD patients. It significantly elevates serum albumin and dietary protein intake to meet clinical targets without inducing adverse metabolic effects. “Egg Bite” represents a promising tool for managing PEW, though longer-term studies are needed to evaluate its impact on body composition and clinical outcomes
Influence of Body Weight on Achieving Indinavir Concentrations Within Its Therapeutic Window in HIV-Infected Thai Patients Receiving Indinavir Boosted With Ritonavir
No full textIndinavir boosted with ritonavir (IDV/r) dosing with 400/100 mg, twice daily, is preferred in Thai adults, but this dose can lead to concentrations close to the boundaries of its therapeutic window. The objectives of this analysis were to validate a population pharmacokinetic model to describe IDV/r concentrations in HIV-infected Thai patients and to investigate the impact of patient characteristics on achieving adequate IDV concentrations. IDV/r concentration data from 513 plasma samples were available. Population means and variances of pharmacokinetic parameters were estimated using a nonlinear mixed effects regression model (NONMEM Version VI). Monte Carlo simulations were performed to estimate the probability of achieving IDV concentrations within its therapeutic window. IDV/r pharmacokinetics were best described by a one-compartment model coupled with a single transit compartment absorption model. Body weight influenced indinavir apparent oral clearance and volume of distribution and allometric scaling significantly reduced the interindividual variability. Final population estimates (interindividual variability in percentage) of indinavir apparent oral clearance and volume of distribution were 21.3 L/h/70 kg (30%) and 90.7 L/70 kg (22%), respectively. Based on model simulations, the probability of achieving an IDV trough concentration greater than 0.1 mg/L was greater than 99% for 600/100 mg and greater than 98% for 400/100 mg, twice daily, in patients weighing 40 to 80 kg. However, the probability of achieving IDV concentrations associated with an increased risk of drug toxicity (greater than 10.0 mg/L) increased from 1% to 10% with 600/100 mg compared with less than 1% with 400/100 mg when body weight decreased from 80 to 40 kg. The validated model developed predicts that 400/100 mg of IDV/r, twice daily, provides indinavir concentrations within the recommended therapeutic window for the majority of patients. The risk of toxic drug concentrations increases rapidly with IDV/r dose of 600/100 mg for patients less than 50 kg and therapeutic drug monitoring of IDV concentrations would help to reduce the risk of IDV-induced nephrotoxicity
HIV RNA measurement in dried blood spots of HIV-infected patients in Thailand using Abbott m2000 system
No full textWorld Health Organization recommends using dried blood spots (DBS) for HIV RNA viral load (VL) measurement whenever plasma processing is not convenient or feasible. DBS collected from 80 treatment-naïve HIV-infected patients presenting in three hospitals of two different regions of Thailand were shipped to a central laboratory along with corresponding plasma specimens. Viral load was measured in both DBS and plasma using the Abbott m2000 system. HIV RNA levels were strongly correlated (r = 0.94) with a mean of differences of 0.23 log10 copies/mL. Using the 1,000 copies/mL cut-off, the sensitivity of DBS was 97% (95%CI, 91–100%) and specificity was 75% (95%CI, 19–99%). DBS are useful to scale-up HIV RNA VL testing in settings with limited access to VL testing.</div
Long-Term Hepatitis B Virus (HBV) Response to Lamivudine-Containing Highly Active Antiretroviral Therapy in HIV-HBV Co-Infected Patients in Thailand
No full textBackground: Approximately 4 million of people are co-infected with HIV and Hepatitis B virus (HBV). In resource-limited settings, the majority of HIV-infected patients initiate first-line highly active antiretroviral therapy containing lamivudine (3TC-containing-HAART) and long-term virological response of HBV to lamivudine-containing HAART in co-infected patients is not well known. Methodology/Principal Finding: HIV-HBV co-infected patients enrolled in the PHPT cohort (ClinicalTrials.gov NCT00433030) and initiating a 3TC-containing-HAART regimen were included. HBV-DNA, HIV-RNA, CD4+ T-cell counts and alanine transaminase were measured at baseline, 3 months, 12 months and then every 6 months up to 5 years. Kaplan-Meier analysis was used to estimate the cumulative rates of patients who achieved and maintained HBV-DNA suppression. Of 30 co-infected patients, 19 were positive for HBe antigen (HBeAg). At initiation of 3TC-containing-HAART, median HBV DNA and HIV RNA levels were 7.35 IU/mL and 4.47 copies/mL, respectively. At 12 months, 67% of patients achieved HBV DNA suppression: 100% of HBeAg-negative patients and 47% of HBeAg-positive. Seventy-three percent of patients had HIV RNA below 50 copies/mL. The cumulative rates of maintained HBV-DNA suppression among the 23 patients who achieved HBV-DNA suppression were 91%, 87%, and 80% at 1, 2, and 4 years respectively. Of 17 patients who maintained HBV-DNA suppression while still on 3TC, 4 (24%) lost HBsAg and 7 of 8 (88%) HBeAg-positive patients lost HBeAg at their last visit (median duration, 59 months). HBV breakthrough was observed only in HBeAg-positive patients and 6 of 7 patients presenting HBV breakthrough had the rtM204I/V mutations associated with 3TC resistance along with rtL180M and/or rtV173L. Conclusions: All HBeAg-negative patients and 63% of HBeAg-positive HIV-HBV co-infected patients achieved long-term HBV DNA suppression while on 3TC-containing-HAART. This study provides information useful for the management of co-infected patients in resource-limited countries where the vast majority of co-infected patients are currently receiving 3TC.Version of Recor
HIV RNA measurement in dried blood spots of HIV-infected patients in Thailand using Abbott m2000 system - Fig 1
No full text(A) Regression analysis of HIV RNA levels in paired plasma and DBS specimens from 80 participants. (B) Bland-Altman analysis of agreement between HIV RNA levels in 80 paired plasma and DBS specimen. The horizontal lines represent the mean difference and +2 standard deviations (SD).</p
Intraperitoneal cefepime monotherapy versus combination therapy of cefazolin plus ceftazidime for empirical treatment of CAPD-associated peritonitis: A multicenter, open-label, noninferiority, randomized, controlled trial
No full textRationale & Objective: Compared to combination therapy, intraperitoneal (IP) cefepime monotherapy for continuous ambulatory peritoneal dialysis (CAPD)-associated peritonitis may provide potential benefits in lowering staff burden, shortening time-consuming antibiotic preparation, and reducing bag contamination risk. This study sought to evaluate whether cefepime monotherapy is noninferior to combination regimens. Study Design: Multicenter, open-label, noninferiority, randomized, controlled trial. Setting & Participants: Adult incident peritoneal dialysis (PD) patients with CAPD-associated peritonitis in 8 PD centers in Thailand. Interventions: Random assignment to either IP monotherapy of cefepime, 1 g/d, or IP combination of cefazolin and ceftazidime, 1 g/d, both given as continuous dosing. Outcomes: Primary end point: resolution of peritonitis at day 10 (primary treatment response). Secondary outcomes: initial response (day 5), complete cure (relapse/recurrence-free response 28 days after treatment completion), relapsing/recurrent peritonitis, and death from any cause. Noninferiority would be confirmed for the primary outcome if the lower margin of the 1-sided 95% CI was not less than −10% for difference in the primary response rate. A 2-sided 90% CI was used to demonstrate the upper or lower border of the 1-sided 95% CI. Results: There were 144 eligible patients with CAPD-associated peritonitis, of whom 70 and 74 patients were in the monotherapy and combination-therapy groups, respectively. Baseline demographic and clinical characteristics were not different between the groups. The primary response was 82.6% in the monotherapy group and 81.1% in the combination-therapy group (treatment difference, 1.5%; 90% CI, −9.1% to 12.1%; P = 0.04). There was no significant difference in the monotherapy group compared with the combination-therapy group in terms of initial response rate (65.7% vs 60.8%; treatment difference, 4.9%; 95% CI, −10.8% to 20.6%; P = 0.5) and complete cure rate (80.0% vs 80.6%; treatment difference, −0.6%; 95% CI, −13.9% to 12.8%; P = 0.7). Relapsing and recurrent peritonitis occurred in 4.6% and 4.6% of the monotherapy group and 4.2% and 5.6% of the combination-therapy group (P = 0.9 and P = 0.8, respectively). There was nominally higher all-cause mortality in the monotherapy group (7.1% vs 2.7%; treatment difference, 4.4%; 95% CI, −2.6% to 11.5%), but this difference was not statistically significant (P = 0.2). Limitation: Not double blind. Conclusions: IP cefepime monotherapy was noninferior to conventional combination therapy for resolution of CAPD-associated peritonitis at day 10 and may be a reasonable alternative first-line treatment. Funding: This study is supported by The Kidney Foundation of Thailand (R5879), Thailand; Rachadaphiseksompotch Fund (RA56/006) and Rachadaphicseksompotch Endorsement Fund (CU-GRS_61_06_30_01), Chulalongkorn University, Thailand; National Research Council of Thailand (156/2560), Thailand; and Thailand Research Foundation (IRG5780017), Thailand. Trial Registration: Registered at ClinicalTrials.gov with study number NCT02872038
Baseline characteristics of study population.
No full textBaseline characteristics of study population.</p
Spiritual well‐being and its relationship with patient characteristics and other patient‐reported outcomes in peritoneal dialysis patients: Findings from the PDOPPS
No full textBackgroundSpiritual well-being (SWB), an individual's understanding of the meaning and purpose of life, may help patients with chronic or terminal illnesses cope with their diseases. This study aimed to assess SWB in patients on peritoneal dialysis (PD), as well as its relationship with patient characteristics and patient-reported outcomes (PRO).MethodsThe data were obtained from questionnaires that formed part of the PD Outcomes and Practice Patterns Study (PDOPPS). Measures used in this study were SWB scores derived from the WHO quality of life, spirituality, religiousness and personal beliefs (WHOQOL-SRPB) tool including 32 items from eight facets; physical (PCS) and mental component summary (MCS) scores of the 12-Item Short-Form Health Survey (SF-12), Center of Epidemiologic Studies Depression Scale-10 (CES-D-10) scores, burden of kidney disease scores and functional status scores.ResultsOverall, 529 out of 848 participants (62%) completely responded to the questionnaires and were included in the analysis. Over two-thirds of PD patients (70%) had moderate or higher SWB scores. The SWB scores were significantly lower in patients with age >65 years and unemployed status. SWB scores positively correlated with higher PCS, MCS, burden of kidney disease scores and functional status scores, while negatively correlated with depression scores by CES-D-10 scale. Patients who reported significant depressive symptoms (CES-D-10 score ≥ 10) had significantly lower SWB scores.ConclusionBetter SWB was significantly associated with better health-related QOL (HRQOL) and the absence of depressive symptoms. SWB may be an essential consideration in the delivery of high-quality PD
