Prevalence, predictors, and prognosis of serious infections in Takayasu arteritis - a cohort study.

OBJECTIVE: To describe the incidence, risk factors, and outcomes associated with serious infections in patients with Takayasu arteritis (TAK). METHODS: Serious infections (defined as infections resulting in hospitalization or death or unusual infections like tuberculosis) were identified from a cohort of patients with TAK. Corticosteroids and disease-modifying anti-rheumatic drug (DMARD) use at the time of serious infection was noted. Demographic characteristics, clinical presentation, angiography, and disease activity at presentation and the use of DMARDs during follow-up were compared between patients with TAK with or without serious infections. Mortality in patients with TAK who developed serious infections was compared with those without was compared using hazard ratios (HR, with 95%CI). RESULTS: Of 238 patients with TAK, 38 (15.97%) had developed serious infections (50 episodes, multiple episodes in 8, three episodes resulted in death). Among the 38 initial episodes, 11/38 occurred in those not on corticosteroids and 14/38 in those not on DMARDs. Pneumonia (n=19) was the most common infection, followed by tuberculosis (n=12). Patients with TAK who developed serious infections vs those without had higher disease activity at presentation (active disease 97.37% vs 69.50%, ITAS2010 12.66±7.29 vs 10.16±7.02, DEI.TAK 11.21± 6.14 vs 8.76±6.07) and more frequently were initiated on corticosteroids or DMARDs. Hazard ratios calculated using exponential parametric regression survival-time model revealed increased mortality rate in patients with TAK who developed serious infections (HR 5.52, 95%CI 1.75-17.39). CONCLUSION: Serious infections, which occurred in the absence of immunosuppressive treatment in about one-fifth, were associated with increased mortality in patients with TAK.

Clinico-epidemiological characteristics of early- versus late-onset cytomegalovirus disease among renal transplant recipients: A two-decade experience.

BACKGROUND: Reactivation of cytomegalovirus (CMV) infection in transplant patients is high because of immunosuppression. We have evaluated the clinical and epidemiological characteristics of early versus late onset of CMV infection among renal transplant recipients. METHODS: A single center retrospective observational study was conducted among renal transplant recipients who underwent kidney transplant between January 2002 and December 2021. CMV disease was classified as early or late depending on its detection prior to or after 90 days post-transplantation. Herein, we reported the differences between early and late onset of CMV disease with respect to clinical symptoms, the use of immunosuppression and the impact on graft outcomes. RESULTS: Out of total 2164 renal transplant recipients, 156 patients (7.2%) were diagnosed with CMV disease. Among these 156 patients, 25 patients (16%) had early CMV while 131 patients (84%) had late CMV. Overall, the two groups did not differ with respect to the induction or maintenance of immunosuppressive agents. However, the proportion of CMV syndrome was greater among early (56.0%) than late (26.7%) CMV groups (p = 0.01). In contrast, tissue invasive disease was more frequent among late (73.3%) in comparison to early (44.0%) CMV groups (p = 0.01). Among clinical symptoms, diarrhea was more frequent in late (63.4%) vs. early (36%) CMV-affected patients (p = 0.01). Graft loss occurred in 4.0% of early CMV group vs. 25.2% of late CMV group (p = 0.03). Neither of the clinical groups differed with respect to occurrence of biopsy-proven allograft rejection post-infection. CONCLUSIONS: Early CMV disease presents more frequently as CMV syndrome while late CMV disease usually manifests itself as tissue invasive disease. Graft loss is more common in patients with late onset of CMV disease.

To leave no one behind: Assessing utilization of maternal newborn and child health services by all the 13 particularly vulnerable tribal groups (PVTGs) of Odisha, India.

BACKGROUND: Indigenous tribal people experience lower coverage of maternal, newborn and child healthcare (MNCH) services worldwide, including in India. Meanwhile, Indian tribal people comprise a special sub-population who are even more isolated, marginalized and underserved, designated as particularly vulnerable tribal groups (PVTGs). However, there is an extreme paucity of evidence on how this most vulnerable sub-population utilizes health services. Therefore, we aimed to estimate MNCH service utilization by all the 13 PVTGs of the eastern Indian state of Odisha and compare that with state and national rates. METHODS: A total of 1186 eligible mothers who gave birth to a live child in last 5 years, were interviewed using a validated questionnaire. The weighted MNCH service utilization rates were estimated for antenatal care (ANC), intranatal care (INC), postnatal care (PNC) and immunization (for 12-23-month-old children). The same rates were estimated for state (n = 7144) and nationally representative samples (n = 176 843) from National Family Health Survey-5. RESULTS: The ANC service utilization among PVTGs were considerably higher than national average except for early pregnancy registration (PVTGs 67% versus national 79.9%), and 5 ANC components (80.8% versus 82.3%). However, their institutional delivery rates (77.9%) were lower than averages for Odisha (93.1%) and India (90.1%). The PNC and immunization rates were substantially higher than the national averages. Furthermore, the main reasons behind greater home delivery in the PVTGs were accessibility issues (29.9%) and cultural barriers (23.1%). CONCLUSION: Ours was the first study of MNCH service utilization by PVTGs of an Indian state. It is very pleasantly surprising to note that the most vulnerable subpopulation of India, the PVTGs, have achieved comparable or often greater utilization rates than the national average, which may be attributable to overall significantly better performance by the Odisha state. However, PVTGs have underperformed in terms of timely pregnancy registration and institutional delivery, which should be urgently addressed.

Renal artery involvement is associated with increased morbidity but not mortality in Takayasu arteritis: a matched cohort study of 215 patients.

BACKGROUND: We analyzed differences in presentation and survival of Takayasu arteritis (TAK) with or without renal artery involvement (RAI) from a large monocentric cohort of patients with TAK. METHODS: Clinical and angiographic features were compared between TAK with versus without RAI, with bilateral versus unilateral RAI, and with bilateral RAI versus without RAI using multivariable-adjusted logistic regression. Inter-group differences in survival were analyzed [hazard ratios (HR) with 95% confidence intervals (95%CI)] adjusted for gender, age at disease onset, diagnostic delay, baseline disease activity, and significant clinical/angiographic inter-group differences after multivariable-adjustment/propensity score matching (PSM). RESULTS: Of 215 TAK, 117(54.42%) had RAI [66(56.41%) bilateral]. TAK with RAI or with bilateral RAI had earlier disease onset than without RAI (p < 0.001). Chronic renal failure (CRF) was exclusively seen in TAK with RAI. TAK with RAI (vs without RAI) had more frequent hypertension (p = 0.001), heart failure (p = 0.047), abdominal aorta (p = 0.001) or superior mesenteric artery involvement (p = 0.018). TAK with bilateral RAI (vs unilateral RAI) more often had hypertension (p = 0.011) and blurring of vision (p = 0.049). TAK with bilateral RAI (vs without RAI) more frequently had hypertension (p = 0.002), heart failure (p = 0.036), abdominal aorta (p < 0.001), superior mesenteric artery (p = 0.002), or left subclavian artery involvement (p = 0.041). Despite higher morbidity (hypertension, CRF), mortality risk was not increased with RAI vs without RAI (HR 2.32, 95%CI 0.61-8.78), with bilateral RAI vs unilateral RAI (HR 2.65, 95%CI 0.52-13.42) or without RAI (HR 3.16, 95%CI 0.79-12.70) even after multivariable adjustment or PSM. CONCLUSION: RAI is associated with increased morbidity (CRF, hypertension, heart failure) but does not adversely affect survival in TAK. Key Points •Renal artery involvement in TAK is associated with chronic renal failure. •TAK with renal artery involvement more often have heart failure and hypertension. •Bilateral renal artery involvement (compared with unilateral) is more often associated with hypertension and visual symptoms. •Renal artery involvement is not associated with an increased risk of mortality in TAK.

Increased mortality rate in Takayasu arteritis is largely driven by cardiovascular disease-a cohort study.

OBJECTIVES: To analyze the risk, causes, and predictors of mortality in Takayasu arteritis (TAK). METHODS: Survival was assessed in a cohort of patients with TAK using Kaplan-Meier curves. Age- and sex-standardized mortality ratio (SMR = observed: expected deaths) for TAK were calculated by applying age- and sex-specific mortality rates for the local population to calculate expected deaths. Hazard ratios (HR with 95%CI) for predictors of mortality based on demographic characteristics, presenting features, baseline angiographic involvement, disease activity, number of immunosuppressive medications used, procedures related to TAK, and any serious infection were calculated using Cox regression or exponential parametric regression models. RESULTS: Among 224 patients with TAK (159 females, mean follow-up duration 44.36 months), survival at 1, 2, 5, and 10 years was 97.34%, 96.05%, 93.93%, and 89.23%, respectively. Twelve deaths were observed, most of which were due to cardiovascular disease (heart failure, myocardial infarction, stroke). Mortality risk was significantly higher with TAK (SMR 17.29, 95%CI 8.95-30.11) than the general population. Earlier age at disease onset (HR 0.90, 95%CI 0.83-0.98; or pediatric-onset vs adult-onset disease, HR 5.51, 95%CI 1.57-19.32), higher disease activity scores (ITAS2010: HR 1.15, 95%CI 1.05-1.25, DEI.TAK: HR 1.18, 95%CI 1.08-1.29), any serious infections (HR 5.43, 95%CI 1.72-17.12), heart failure (HR 7.83, 95%CI 2.17-28.16), or coeliac trunk involvement at baseline (HR 4.01, 95%CI 1.26-12.75) were associated with elevated mortality risk. CONCLUSION: Patients with TAK had an elevated risk of mortality as compared with the general population. Cardiovascular disease was the leading cause of death in TAK.

Takayasu Arteritis with Severe Renal Artery Stenosis and an Aberrant Renal Artery in a Child: A Case Report and Discussion.

Takayasu arteritis (TA) is a chronic, idiopathic large vessel vasculitis mainly affecting the aorta and its major branches. It is one of the common causes of reno-vascular hypertension in Indian children. We report a ten-year-old boy who presented with hypertensive encephalopathy, proteinuria, and haematuria without any renal dysfunction. He was initially diagnosed to be a case of acute post streptococcal glomerulonephritis, but detailed clinical examination and haemato-radiological investigations revealed Takayasu arteritis, type V (P+). He had unilateral severe renal artery stenosis along with a small kidney and an aberrant renal artery on left side. He is found to have resistant hypertension, unresponsive to multiple anti-hypertensive drugs, and had a fatal outcome. This case illustrates renal involvement in TA and the significance of four-limb blood pressure measurement in any non-obese child with hypertension. Furthermore, the possible role of aberrant renal artery in the pathogenesis of resistant hypertension is discussed.

Community-friendly tool to assess patient satisfaction in tuberculosis programme in the covid pandemic period; Bhubaneswar; India.

National Tuberculosis Elimination Programme (NTEP) is a priority programme for India, given that India is one of the 20 countries with high burden of TB. Odisha (a state in Eastern India) in 2017 reported 159/lakh/year cases as against a national average incidence of 138.33/lakh/year. Thus, the state, under an encouraging political milieu went to vigorously implement the newer initiatives outlined in the National Strategic Plan 2020-25, the result of which in 2021 Odisha was ranked second in the country for its efforts on TB elimination. The current article attempts to take community feedback on the programmatic endeavours, by using a tool for client satisfaction. 350 consecutive subjects, adults aged 18 years and above consented among the 465 who were diagnosed and started on treatment between 5/4/21 to 5/4/22. The selected subjects were interviewed after confirmation of diagnosis at one DOTS centre in an urban city, using a pre-designed and pretested tool after taking requisite ethical permission from the institute as well as after consent from the participating subjects. The tool had 10 items on structure; 10 items on the process and 3 on outcome each rated on a Likert scale of 1-5 (very satisfied to very dissatisfied) and lastly a score on 10 scale for overall satisfaction. For all the 24 items; alpha Cronbach coefficient was 0.928 (bootstrap 95% CI); for subscales infrastructure, process and outcome isolatedly was 0.931, 0.912 and 0.959 respectively. This shows that the questionnaire had very good reliability. Infrastructure mean score for all 10 questions was above 4.5; for processes, it was <4.05 for a few questions and mainly these referred to Out of pocket expenditures and waiting time; outcome again for all three questions mean score was near or above 4.4. The overall score was between 5 and 10; maximally at 8. This simple tool gave clear-cut hints at the best picture scenario, as the study was done at a single DOTS service centre in the capital city of the state, which ran effectively even during the pandemic. However, it brings out the weak points in the processes like the cost incurred to come to the centre and communication with ancillary staff. No difference in satisfaction levels was reported among pulmonary and extrapulmonary cases (ratio 8.4:1.5) in this study in the covid period; with overall satisfaction being 4.45 ± 0.44 and 4.41 ± 0.25 respectively. The promptness in the programmatic services at the DOTS centre under study is encouraging but warrants conformity with DOTS centres in rural and far-to-reach areas. Best evaluation of achievements of programme can be determined by word of mouth of the beneficiaries. Hence, this tool if replicated at all service centres can help programme managers plug any disconnects in service delivery and assure good satisfaction from all quarters.

Social reintegration of fistula survivors in North Central Nigeria: A case for rehabilitation.

Obstetric fistula remains one of the neglected forms of chronic maternal morbidity that occurs mainly in low- and middle-income countries. We explored the rehabilitation and reintegration experiences of 15 fistula survivors in North Central Nigeria. We employed a qualitative research design, guided by Constructivist Worldview, involving narrative interviewing technique in conducting in-depth interviews. Key benefits of rehabilitation reported by the participants included socioeconomic-financial empowerment and autonomy, improved social status, and freedom from self-isolation. Additionally, participants experienced positive psychological effects, such as increased self-worth and self-confidence. However, prolonged recovery periods and stigmatization issues were noted as barriers to successful reintegration post rehabilitation. On the other hand, the presence of family and community support, along with the resolution of stigma, were found to be facilitators of social reintegration. Considering the holistic benefits of rehabilitation, we recommend implementing a comprehensive care management program for fistula survivors to facilitate successful social reintegration.

Paediatric-onset Takayasu's arteritis associates with worse survival than adult-onset Takayasu's arteritis. A matched retrospective cohort study.

OBJECTIVES: A subset of Takayasu's arteritis (TAK) begins in the paediatric age group (≤18 years). Differences in prognosis between paediatric-onset and adult-onset TAK are unclear. We compared the differences in the presentation and survival between paediatric-onset and adult-onset TAK in our cohort of TAK. METHODS: From a retrospective cohort of TAK, clinical presentation, angiographic features, treatments received, disease activity, and survival were compared between paediatric-onset and adult-onset TAK. Multivariable-adjusted logistic regression models were used to compute adjusted odds ratio (aOR) with 95% confidence intervals (95%CI) for paediatric-onset vs. adult-onset TAK. Hazard ratios (HR, with 95%CI) for mortality with paediatric-onset vs adult-onset TAK (crude, adjusted for prognostic covariates or differences in presentation) and propensity score-matched survival analyses were estimated. RESULTS: Among 56 paediatric-onset and 135 adult-onset TAK, chest pain (aOR 3.21, 95%CI 1.06-9.74), heart failure (aOR 3.16, 95%CI 1.05-9.53), headache (aOR 2.60, 95%CI 1.01-6.74), ascending aorta (aOR 3.02, 95%CI 1.04-8.80) and left renal artery involvement (aOR 2.45, 95%CI 1.04-5.80) were more frequent in paediatric-onset TAK. Despite similar longitudinal patterns of disease activity and glucocorticoid or disease-modifying antirheumatic drug (DMARD) use, mortality was higher for paediatric-onset TAK (HR, unadjusted 6.13, 95%CI 1.51-24.91; adjusted for prognostic covariates gender, diagnostic delay, baseline disease activity, number of conventional and biologic/targeted synthetic DMARDs used, 4.97, 95%CI 1.20-20.58; adjusted for differences between groups 5.54, 95%CI 1.22-25.09; after propensity-score matching for prognostic covariates, 54 pairs, log-rank p-value 0.026). CONCLUSIONS: Considering the greater mortality risk, greater vigilance is required while managing paediatric-onset TAK.

Clinicopathologic characteristics and outcomes of late onset lupus nephritis: a single centre experience.

Systemic Lupus Erythematosus (SLE) occurs in the reproductive age group. Renal involvement occurs less frequently in late-onset SLE than in reproductive-age SLE patients. Here, we aimed to study the clinical, serological and histopathological characteristics of late-onset lupus nephritis (LN). Late-onset LN was defined as disease onset after 47 years of age, corresponding to the average menopausal age. Records of biopsy proven late-onset lupus nephritis patients diagnosed between June 2000 and June 2020 were reviewed. Late-onset LN constituted 53 of 4420 patients (1.2%) biopsied during the study period. Females represented 90.65% of the cohort. Mean age of the cohort was 49.5 ± 7.05 years at the time of SLE diagnosis while its renal presentation was delayed by median duration of 10 months (IQR 3-48 months). Renal failure was present in 28 patients (52.8%) with acute kidney injury (AKI) (28.3%, n = 15) as the most common presentation. On histopathological analysis, class IV was observed in 23 patients (43.5%), crescents were observed in one-third cases and lupus vasculopathy in 4 patients (7.5%). All patients received steroids. Majority of patients (43.3%; n = 23) received Euro lupus protocol for induction. On median follow up duration of 82 months, renal flares were noted in 9 patients (17%) and 8 patients (15.1%) became dialysis dependent. Among 11 patients (21%) with infectious complications, 7 patients (13.2%) suffered from tuberculosis. Infections caused three-fourth of the deaths. Late-onset lupus nephritis is rare and presents as renal failure in majority. Renal biopsy affects the clinical decision of judicious use of immunosuppression which is imperative due to high rate of infections in this cohort.

Antibiotic-resistant bacteria in bovine milk in India.

Antibiotic resistance (ABR) is a global issue that draws the attention of all healthcare experts in the veterinary and medical fields. Of various factors, indiscriminate and unregulated antibiotic usage in the animals reared for food production, especially in cows and buffaloes suffering from mastitis, contribute significantly to the rising incidence of resistant bacteria. A literature survey reveals the spread of resistant strains of mastitis-causing bacteria, like Staphylococcus aureus and Escherichia coli, to humans. In addition, antibiotic residues detected in milk samples against all major groups of antibiotics are likely to enter the human body through the food chain and aggravate the condition. The cumulative effects of ABR have emerged as a silent killer. The benefits of systematic surveillance on ABR in India are yet to be available. Here is an attempt to understand the ABR burden in India associated with bovine milk and its mitigation strategies.

To what extent classic socio-economic determinants explain trends of anaemia in tribal and non-tribal women of reproductive age in India? Findings from four National Family Heath Surveys (1998-2021).

BACKGROUND: Despite unprecedented socio-economic growth experienced by Indians in the past few decades, and a long history of anti-anaemia public health measures, prevalence of anaemia in Indian non-pregnant women of reproductive age group (NPWRA) has not declined. This warrants a firm understanding of what explains the anaemia situation over time, preferably by sub-populations. Therefore, we aimed to examine the trends of anaemia in tribal NPWRA (least privileged) and compare with the trends in the NPWRA of general caste (most privileged) between 1998 to 2021. Additionally, the study also explored explanation of any decline and tribal/general narrowing of these trends. METHODS: We studied four rounds of National Family Health Survey (1998-99, 2005-06, 2015-16, 2019-21). We examined the trend of anaemia (haemoglobin < 12 g/dl) and its possible determinants in tribal and general NPWRA and estimated the portion of "decline" and "narrowing" that could be explained by the underlying and intermediate determinants (wealth, education, residence, parity and food security) using multiple logistic regression. RESULTS: The distribution of determinants improved over 23 years in both the groups but more in tribals. But anaemia either remained unchanged or increased in both except 7.1 points decline in tribals between 2006-2016, leading also to 7 points narrowing of tribal/general gap. The modest attenuation of beta coefficients representing the change of anaemia prevalence (log of odds) in tribals from -0.314(-0.377, -0.251) to -0.242(-0.308, -0.176) after adjustment with determinants could explain only 23% of the decline. Similarly, only 7% of the narrowing of the tribal/general anaemia gap could be explained. CONCLUSIONS: The structural determinants wealth, education, food security, parity and urban amenities improved immensely in India but anaemia did not decline in this 23-year period. This implies that the "usual suspects" - the structural determinants are not the main drivers of anaemia in the country. The main driver may be absolute and/or functional deficiency status of micronutrients including iron attributable to inadequate uptake and absorption of these elements from Indian diets; and therefore, their effects are noticeable in every socio-economic stratum of India. Future research for aetiologies and new interventions for anaemia alleviation in India may focus on these factors.

Assessment of sanitation and drinking water facilities among slum households in Bhubaneswar, Odisha - A cross-sectional study.

Aim: The study aims to assess the practice of using unsafe drinking water and sanitary practices among the population dwelling in slum settings of Bhubaneswar city, Odisha, India. Subjects and Methods: A cross-sectional study was conducted among 288 households in the Bhubaneswar slums of Chandrasekharpur, Neeladri Vihar, and Trinatha basti. A questionnaire was administered face to face. Descriptive statistics were used to define the participants' sociodemographic characteristics, household information, drinking water, latrine characteristics, and waste disposal. Results: The majority (59.7%) resided in kutcha households in notified slum areas, and 89.6% were reportedly illiterate. About 92.7% resided in a deplorable condition, relying on piped water (79.5%) from the community sources and 20.5% used it for drinking and household purposes. Around 83% of the respondents stated they did not treat water before consumption. Bathroom facilities were found to be inadequate, and 74.3% used pit latrines. The majority of household wastes (83%) were managed by directly letting them to the drainage system untreated. As a consequence, 91% reported breeding of flies and mosquitoes near their household premises and 70.5% stated having fever in the past 6 months. Conclusion: Despite the government's initiatives to improve water, sanitation, and hygiene (WASH) strategies, an extensive gap in practice was observed. As a result, Bhubaneswar municipality must strictly enforce policy and regulatory guidelines concerning WASH to improve the sanitation practices, particularly in the areas of drinking water and household waste management.

Antibody response to ChAdOx1 nCoV-19 (Covishield®) vaccine in people on maintenance hemodialysis.

INTRODUCTION: People on renal replacement therapy (RRT) have a high risk of COVID-19 infection and subsequent death. COVID-19 vaccination is strongly recommended for those on RRT. Data are limited on the immune response of the ChAdOx1 nCoV-19/AZD1222 (Covishield®) vaccine in patients on RRT. METHODS: A prospective cohort of adult (age > 18 years), on RRT in the form of hemodialysis were included and received two intramuscular doses of Covishield®. A blood specimen of 5.0 mL was collected at two time points, within a few days before administering the first dose of the vaccine and at 4-16 weeks after the second dose. According to their prior COVID-19 infection status, the participants were grouped as (i) prior symptomatic COVID-19 infection, (ii) prior asymptomatic COVID-19 infection, and (iii) no prior COVID-19 infection. RESULTS: A large proportion (81%) of participants had anti-spike antibodies (ASAb) before vaccination, and a reasonable proportion (30%) also had neutralizing antibodies (NAb). The titer of ASAb was relatively low (207 U/mL) before vaccination. The ASAb titer (9405 [1635-25,000] U/mL) and percentage of NAb (96.4% [59.6-98.1%]) were markedly increased following the administration of two doses of the vaccine. The participants' prior COVID-19 exposure status did not influence the rise in ASAb titer and NAb percentage. Further, administering two doses of the Covishield vaccine helps them achieve a high ASAb titer. CONCLUSION: Two doses of ChAdOx1 nCoV-19/AZD1222 (Covishield®) vaccine, given 12 weeks apart, achieve a high titer of ASAb and a high percentage of NAb in people on hemodialysis.

Mental Health Status, Coping Strategies During Covid-19 Pandemic Among Undergraduate Students of Healthcare Profession.

The present study aimed to assess the prevalence of psychological distress, associated lifestyle behaviors, and associated coping strategies among the students of healthcare profession. A total of 588 medical, dental, and nursing students studying in institutes of health sciences, KIIT University, Bhubaneswar, India participated in this cross-sectional online survey during September-October, 2020. A semi-structured questionnaire, DASS-21questionnaire, and Brief COPE were used to collect relevant information. The proportion of students experiencing symptoms of depression, anxiety, and stress was 26.2%, 27.7%, and 9.7%, respectively. Body mass index, presence of comorbidity, and soft drink consumption were significantly associated with psychological distress. Students experiencing psychological distress were applying emotion-focused coping behaviors (venting, acceptance, self-blame, substance use, religion) and avoidant coping behaviors (self-distraction, behavioral disengagement, denial). The prevalence of psychological distress among the students of health profession studying in KIIT University of Bhubaneswar during the period of Covid-19 pandemic is low and it can be further lowered by designing appropriate interventions incorporating healthy lifestyle behaviors and suitable coping strategies thereby ensuring sound mental health of these students.

Protocol and Methods: Role of Levothyroxine on the Progression of Chronic Kidney Disease in Subclinical Hypothyroid Populations (LP-CKD) - A Multicenter Randomized Controlled Trial.

Introduction: Subclinical hypothyroidism (SCH) is highly prevalent and associated with chronic kidney disease (CKD). However, it is still unanswered whether the restoration of euthyroid status in these patients will be beneficial in retarding a decline in glomerular filtration rate in early CKD patients. We aim to evaluate the efficacy of levothyroxine therapy versus placebo in slowing estimated glomerular filtration rate (eGFR) decline among CKD patients (stage 2-4) with SCH. Methods: This study will be a multicentric, double-blind, randomized, parallel-group, placebo-controlled study. A total of 500 CKD patients, 250 patients in the treatment group and 250 patients in the placebo group, will be randomized. The randomization between the treatment arm and placebo arm will be performed as per the computer-generated random number table in a 1:1 ratio. The sample size was calculated based on the assumed reduction in eGFR after 1-year follow-up in the treatment and placebo groups of 10% and 25%, respectively, at a minimum two-sided 99% confidence interval and 90% power of the study and considering 20% loss on follow-up. Each patient will be followed every 3 months for at least 1 year after randomization. Individuals completing 1-year follow-up visits will be considered for analysis. The baseline and follow-up data will be compared between the treatment and placebo groups. The study will evaluate the efficacy and safety of levothyroxine therapy versus placebo in slowing eGFR decline among CKD patients (stage 2-4) with SCH. The primary endpoint will be the end of follow-up of the patients, reduction of eGFR by ≥50% from a baseline of that patient, or development of ESKD or death of the patients. The secondary endpoint will be any cardiovascular event or arrhythmia after the institution of the drug.

Pre-Pulseless Takayasu Arteritis is Associated with Distinct Clinical and Angiographic Features but Similar Outcomes - A Cohort Study.

Objectives: To compare the presentation, angiographic features, evolution, and prognosis of prepulseless Takayasu arteritis (TAK) with TAK with pulse loss. Methods: Pre-pulseless TAK (defined as without pulse loss in the upper limbs, lower limb, carotid, or subclavian arteries) were identified from a cohort of TAK. Demographic characteristics, clinical features, angiographic involvement, baseline and longitudinal patterns of disease activity, medication use, and mortality rates were compared between pre-pulseless TAK and TAK with pulse loss. Adjusted odds ratios (aOR, with 95%CI) for categorical variables between pre-pulseless TAK and TAK with pulse loss were computed using multivariable-adjusted logistic regression models. Time-to-event data was compared using hazard ratios (HR) with 95%CI. Results: Compared with TAK with pulse loss, pre-pulseless TAK (91/238, 38.24%) more frequently had deranged renal function (aOR 4.43, 95%CI 1.58-12.37) and Hata's type IV disease (aOR 8.02, 95%CI 2.61-24.65), and less often had pulse or blood pressure asymmetry (aOR 0.34, 95%CI 0.18-0.63), limb claudication (aOR for upper limb 0.38, 95%CI 0.18-0.82, for lower limb 0.28, 95%CI 0.12-0.68), right subclavian (aOR 0.45, 95%CI 0.23-0.90) or left carotid artery involvement (aOR 0.42, 95%CI 0.21-0.84). Only two patients with pre-pulseless TAK developed pulse loss on follow-up. Despite fewer pre-pulseless TAK having active disease at presentation, similar proportions of patients in both groups had active disease on follow-up. Survival was similar in both groups (HR for mortality 0.41, 95%CI 0.09-1.90). Conclusion: Pulse loss on follow-up is uncommon in those with prepulseless TAK. Pre-pulseless TAK is associated with similar long-term outcomes to TAK with pulse loss.

Desmopressin Acetate Before Percutaneous Ultrasound-Guided Kidney Biopsy in Patients with Renal Failure - Is it Really Beneficial?

Introduction: The most common complication of percutaneous renal biopsy is bleeding, which can be seen in up to one-third of cases. The aim of this study was to evaluate the effect of prebiopsy administration of intranasal desmopressin acetate in reducing the incidence of biopsy-related bleeding complications in patients with significant renal dysfunction who underwent renal biopsy. Methods: This was a retrospective, observational study of percutaneous native renal biopsies performed at our center from July 2014 to June 2018. Bleeding complication rates of patients with renal failure (estimated glomerular filtration rate [eGFR] <30 mL/minute/1.73 m2) who received desmopressin and those who did not receive desmopressin were compared. Results: Desmopressin administration before renal biopsy in patients with eGFR <30 mL/minute/1.73 m2 was associated with a significant reduction of bleeding complications (major and minor together; P = 0.025) and no significant reduction in major complications (P = 0.616) or intervention rates (P = 0.251) when compared with a group that did not receive desmopressin. Conclusions: While prebiopsy intranasal desmopressin use was associated with a significant reduction of overall bleeding complications including major and minor complications, there was no reduction in the rate of other major complications and interventions.