scholarly journals P0342A STUDY OF TREATMENT WITH RITUXIMAB IN REFRACTORY LUPUS NEPHRITIS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Pranab Jyoti Mahanta ◽  
Manjuri Sharma ◽  
Shahzad Alam ◽  
Prodip Kumar Doley ◽  
Gayatri Pegu ◽  
...  
Keyword(s):  
Lupus Nephritis ◽  
Small Sample Size ◽  
Life Time ◽  
Immunosuppressive Drugs ◽  
Small Sample ◽  
Post Treatment ◽  
Urinary Protein ◽  
Single Center ◽  
Renal Response ◽  
Stage Renal Disease

Abstract Background and Aims SLE patients have 40% to 70% life time risk of developing lupus nephritis (LN). In LN patients rate of end-stage renal disease is 10%, remaining constant in the last 30 years, even after the emergence of various immunosuppressive therapy. SLE is an example of classical antibody-mediated disease and hence treatment with B cell depleting agent (like the use of Rituximab ) appears to be a promising approach for this unwinnable disease from the Roman era. The aim of this study was to analyze the outcome in terms of - no renal response (NRR), complete renal response (CRR) or partial renal response (PRR) at week 24 after rituximab treatment initiation in refractory LN. CRR considered, if serum creatinine (S Cr) level returned to baseline, with a decline in the 24 hour urinary protein to < 500 mg/day. PRR defined as stabilization (+/-25%), or improvement of S Cr, plus a 50% decrease in 24 hour urinary protein (which was < 3.5 gm/day). NRR considered, if participant did not achieve either a CRR or PRR. Method It is a single center prospective observational study, comparing short term (24 week) outcomes in resistant lupus nephritis patients of >18 year age group with weekly (total 4) dose of rituximab therapy. The study was conducted on 25 refractory lupus nephritis patients admitted in Nephrology Department (not responding to conventional immunosuppressive drugs like cyclophosphamide, MMF). Repeat renal biopsy was performed, all baseline investigations were done. Injection Rituximab 375 mg/m2 weekly 0,1,2,3 week along with premedication treatment were given to every patient. The clinical outcome was assessed monthly post-treatment. Results In the study maximum patients were of class IV, n=21 (84 %). Sustained (6 months post treatment) CRR was achieved in n=6 (24%) patients, n=7 (28%) patients achieved PRR, rest n=12 (48%) patients had NRR. Mean blood absolute CD-19 count was significantly negatively correlated with response to rituximab treatment ( p< 0.001) .Mean absolute CD-19 count was 2.33/microliter in CRR, 2.14/microliter in PRR group and 21.25 / microliter in NRR group . No significant side effects of rituximab were observed. Limitations –Small sample size, single center study, long term follow up not considered. Conclusion In refractory LN patients, 24 weeks after Rituximab treatment

scholarly journals Usefulness of mycophenolate mofetil in Indian patients with C3 glomerulopathy

2018 ◽  
Vol 12 (4) ◽  
pp. 483-487 ◽  
Author(s):  
Joyita Bharati ◽  
Karalanglin Tiewsoh ◽  
Ashwani Kumar ◽  
Ritambhra Nada ◽  
Manish Rathi ◽  
...  
Keyword(s):  
Mycophenolate Mofetil ◽  
Small Sample Size ◽  
Initial Response ◽  
Immunosuppressive Agent ◽  
Small Sample ◽  
C3 Glomerulopathy ◽  
Standardized Treatment ◽  
Stage Renal Disease ◽  
End Stage

Abstract Background C3 glomerulopathy (C3G) is a heterogeneous disease caused by alternative complement pathway abnormalities without any standardized treatment. An immunosuppressive agent, mycophenolate mofetil (MMF), has been recently shown to be useful in treating C3G, mainly in studies from the west. We report the clinical outcome of 17 Indian C3G patients treated with MMF with or without steroids. Methods The clinical and histology details of the C3G patients treated with MMF for at least 6 months with a follow-up of at least 12 months were retrieved from the medical records of our center. Results The median serum creatinine and proteinuria at presentation were 0.8 mg/dL and 3.7 g/day, respectively, with the majority (88.2%) presenting as nephrotic syndrome. The mean dose of MMF was 1.65 (±0.56) g/day, and the median duration of MMF therapy was 18 months. Two-thirds (64%) of the patients responded to the treatment, with complete remission in 4 (23%) and partial remission in 7 (41%) (median time: 9 months). Three patients progressed to end-stage renal disease (ESRD) on follow-up. Of the three patients, one (33%) had an initial response in proteinuria to MMF but did not respond after a relapse and subsequently progressed to ESRD and two (67%) other patients were nonresponsive to MMF from the start of the therapy. Conclusion Despite a small sample size and lack of a control arm, this study describes the effectiveness of MMF in treating C3G patients from Asia and forms a basis for future randomized trials.

Internet-Based Self-Help Training for Children and Adolescents with Recurrent Headache: A Pilot Study

2008 ◽  
Vol 36 (2) ◽  
pp. 241-245 ◽  
Author(s):  
Ellen Trautmann ◽  
Birgit Kröner-Herwig
Keyword(s):  
Therapeutic Potential ◽  
Pain Catastrophizing ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Small Sample ◽  
Post Treatment ◽  
The Internet ◽  
Behavioural Treatment ◽  
Self Help ◽  
Cognitive Behavioural

AbstractWe report the results of a randomized controlled trial that compared the efficacy of an internet-based self-help treatment for paediatric headache including chat communication (cognitive-behavioural treatment, CBT) with an internet-based psychoeducation intervention (EDU). In the CBT group, significant pre- to post-treatment decreases were found for headache frequency and pain catastrophizing, but not for headache intensity or duration. In the EDU group none of the variables (frequency, intensity, duration, pain catastrophizing) showed improvement. No significant between group differences were found for headache variables and pain catastrophizing at post-treatment. The patients reported high satisfaction with the internet-based training and a good patient-trainer-alliance. Results were maintained at 6-month follow-up. Due to the small sample size, no general conclusions can be drawn regarding the efficacy of the internet-based training regarding the outcome variables, but the training was well accepted by patients. Further research is necessary to evaluate the therapeutic potential of such interventions.

MO136RELATIONSHIP BETWEEN UPCR AND EGFR IN C3 GLOMERULOPATHY

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Carla Nester ◽  
Patrick Breheny ◽  
Monica Hall ◽  
Alan Charney ◽  
Martin Lefkowitz ◽  
...  
Keyword(s):  
Natural History ◽  
Small Sample Size ◽  
Continuous Variable ◽  
Small Sample ◽  
C3 Glomerulopathy ◽  
University Of Iowa ◽  
History Of ◽  
Stage Renal Disease ◽  
End Stage ◽  
The Relationship

Abstract Background and Aims Considerable knowledge gaps exist in our understanding of the natural history of C3 glomerulopathy (C3G). Disease rarity, multiple nomenclature changes, and the inclusion of dissimilar cases in historical cohorts have precluded retrospective studies to define the natural course of C3G and identify risks for progression to kidney failure (end stage renal disease/ESRD). In the present analysis, we focus on C3G patients with native kidneys and examine the relationship between reductions in UPCR and disease progression as indicated by changes in eGFR. Method Patients included in this study were consented and enrolled in the University of Iowa C3G ReCom Registry, which was created in 2013. Beginning in 2017, complement activity and renal function data were collected prospectively at approximately 6-month intervals to define the natural history of C3G. Analyses were performed across 1-year periods of time (“spans”). To be included in a span, a patient had to meet the following criteria at the start of the 1-year period: native C3G, eGFR ≥30 mL/min/1.73 m2, UPCR ≥1 g/g and ≥12 years of age. An individual patient could be included in more than one span. Results Analyses were performed using 34 one-year spans for 24 patients who met inclusion criteria at the beginning of the 1-year span. Baseline characteristics for the 34 spans were: male, 59%; mean age, 22.7 years; mean eGFR, 83.1 ml/min/1.73m2; mean UPCR, 2.86 g/g; mean plasma C3, 75.1 mg/dL. Similar analyses using only the first 1-year span for each of the 24 patients produced results that were consistent with those generated using all 1-year spans. Limitations of this study include its small sample size and data variability due to its observational nature. Conclusion The findings of this observational study support the premise that reductions in proteinuria are associated with a more stable eGFR in native kidney C3G. Regression analyses using UPCR as a continuous variable demonstrate the relationship between reduction in UPCR and preservation of eGFR. This association was also observed using both change in eGFR by UPCR reduction subgroup and UPCR-eGFR categorical analyses.

Pilot study comparing telephone to in-person delivery of cognitive-behavioural therapy for trauma-related insomnia for rural veterans

2017 ◽  
Vol 24 (9) ◽  
pp. 629-635 ◽  
Author(s):  
C Laurel Franklin ◽  
Jessica L Walton ◽  
Amanda M Raines ◽  
Jessica L Chambliss ◽  
Sheila A Corrigan ◽  
...  
Keyword(s):  
Cognitive Behavioural Therapy ◽  
Small Sample Size ◽  
Meta Analysis ◽  
Mode Of Delivery ◽  
Behavioural Therapy ◽  
Small Sample ◽  
Post Treatment ◽  
Cognitive Behavioural ◽  
To Receive

Introduction It is estimated that 70% of patients with posttraumatic stress disorder (PTSD) have chronic insomnia. A recent meta-analysis examined cognitive-behavioural therapy for insomnia (CBT-I) in veterans with and without PTSD, and suggested that most studies had questionable methodology, but generally supported its effectiveness in this population. Further, while CBT-I via telehealth (i.e. using telecommunication and information technology to deliver health services) has shown effectiveness for primary insomnia, it has not been applied to PTSD-related insomnia. Methods Veterans with insomnia who were diagnosed with PTSD ( n = 12) or having significant subthreshold PTSD symptoms ( n = 6) on the Clinician Administered PTSD Scale were randomly assigned to receive CBT-I in-person ( n = 7) or by telephone ( n = 11), to pilot test the potential effectiveness, acceptability, and feasibility of administering CBT-I in rural veterans. A six-week CBT-I protocol was delivered, and the veteran’s insomnia was assessed at post-treatment and follow-up. Results Given the small sample size, Cohen’s d was used to detect group differences, finding large effect sizes favouring the in-person delivery, until three-months post-treatment when this difference diminished. Most veterans found the treatment acceptable, regardless of mode of delivery. Based on the results, a larger project is feasible. Feasibility for a larger project is favourable. Discussion In summary, our findings uphold and extend previous research. Specifically, current pilot data suggest that telephone-delivered CBT-I may be able to reduce trauma-related insomnia symptoms. Future trials are needed to assess the effectiveness of CBT-I delivered to rural veterans with posttraumatic insomnia.

scholarly journals PROGNOSTIC FACTORS IN MYELODYSPLASTIC SYNDROMES: SINGLE-CENTER EXPERIENCE

2019 ◽  
Vol 141 (7-8) ◽  
pp. 238-246
Keyword(s):  
Prognostic Factors ◽  
Small Sample Size ◽  
Risk Groups ◽  
Small Sample ◽  
World Health ◽  
Single Center ◽  
Single Center Experience ◽  
Age Of Diagnosis ◽  
Transfusion Dependency ◽  
Health Organization

Introduction: Myelodysplastic syndrome (MDS) is one of the most common myeloid neoplasms of elderly characterized by cytopenias and limited therapeutic options. The main aim of this retrospective single-center study was to examine the value of classical prognostic factors. The main outcome of the study was overall survival (OS) defined as death from MDS or any other reason. Methods: We analyzed the medical records of patients diagnosed with MDS at single centre in the period from beginning of 2013 to the end of 2016. Results: Total of 58 patients (median age of diagnosis being 69 years) were included in the study. After median of follow-up of 12 months, median OS was 17 months and estimated 3-year OS rate 25%. Classical prognostic systems such as IPSS, WPSS and R-IPSS were statistically significant prognostic factors discriminating adequately between low and high risk groups in terms of outcome. However, due to small sample size, we were not able to distinguish the most appropriate scoring system. The cytogenetics subgroups according to IPPS and R-IPSS were significant predictors of outcomes underlying its crucial role in MDS diagnosis. Despite the statistical tendency morphological features of MDS (2008 World Health Organization subtype and number of blasts in bone marrow) were not significant predictors of OS. Among clinical features, only presence and degree of anemia and transfusion dependency were significant predictors of inferior survival. Conclusion: The majority of traditional prognostic factors were significant in our cohort in concordance with literature review.

scholarly journals 213. Assessment of Compliance with Order Set and Bundle for Management of Staphylococcus aureus Bacteremia

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S214-S215
Author(s):  
Ryan R Flynn ◽  
Marilee Obritsch ◽  
Veronica Lesselyoung ◽  
Joe Strain ◽  
John Kappes
Keyword(s):  
Staphylococcus Aureus ◽  
Statistical Difference ◽  
Small Sample Size ◽  
Small Sample ◽  
Single Center ◽  
Recurrence Rates ◽  
Adequate Treatment ◽  
Single Center Study ◽  
Center Study ◽  
Order Set

Abstract Background Staphylococcus aureus (S. aureus) is an aerobic gram-positive coccus that causes a variety of infections. S. aureus bloodstream infections, also known as bacteremias, have significant morbidity and mortality and are difficult to eradicate. A single-center study showed a 9.4% recurrence rate for S. aureus bacteremia, despite adequate treatment. The Infectious Disease Society of America (IDSA) recognizes the seriousness of S. aureus infections, particularly methicillin-resistant S. aureus (MRSA), and has released guidance for treatment of these infections. Guidance for S. aureus bacteremias include identification and removal of the source and early optimization of antibiotics. Serial imaging and laboratory monitoring, including repeat blood cultures, are also necessary to establish the duration of therapy, ensure microbiologic eradication, and reduce the risk of long-term complications. Due to the complexity of S. aureus bacteremia, early involvement of infectious diseases (ID) specialists is strongly recommended. Methods This retrospective, single-center study was designed to evaluate the current management of S. aureus bacteremias, including compliance to the elements of the S. aureus order set and bundle. Patients 18 years and older who had a positive blood culture for S. aureus were included in this study. Recurrence of S. aureus infection was assessed at 6 months. Data was analyzed to compare patients with and without ID consults. Results Eighty-four patients met inclusion criteria. ID consultation resulted in a higher percentage of patients achieving 100% compliance with the bundle elements compared to patients without ID consults (73% vs 25%, respectively; p=0.009). For further breakdown of compliance see Table 1. No statistical difference was detected in recurrence rates (11% vs 33%, respectively; p=0.18) or mortality (8% vs 25%, respectively; p= 0.17) possibly due to the small sample size. Table 1. Outcomes Conclusion ID specialist involvement for the treatment of S. aureus bacteremia resulted in greater compliance with the S. aureus bacteremia bundle. No statistical difference in recurrence or mortality rates was detected. Disclosures All Authors: No reported disclosures

Contact Activation Inhibitor, AB023, in Heparin-Free Hemodialysis: Results of a Randomized Phase 2 Clinical Trial

Blood ◽  
2021 ◽  
Author(s):  
Christina U. Lorentz ◽  
Erik I. Tucker ◽  
Norah G. Verbout ◽  
Joseph J Shatzel ◽  
Sven R Olson ◽  
...  
Keyword(s):  
Small Sample Size ◽  
Chronic Hemodialysis ◽  
Small Sample ◽  
Phase 2 ◽  
Contact Activation ◽  
Dialysis Dose ◽  
Double Blind ◽  
Phase 2 Clinical Trial ◽  
Stage Renal Disease ◽  
End Stage

End-stage renal disease (ESRD) patients on chronic hemodialysis have repeated blood exposure to artificial surfaces that can trigger clot formation within the hemodialysis circuit. Dialyzer clotting can lead to anemia despite erythropoietin and iron supplementation. Unfractionated heparin prevents clotting during hemodialysis, but it is not tolerated by all patients. Although heparin-free dialysis is performed, intradialytic blood entrapment can be problematic. To address this issue, we performed a randomized, double-blind, phase 2 study comparing AB023, a unique antibody that binds factor (F) XI and blocks its activation by factor XIIa but not by thrombin, to placebo in 24 patients with ESRD undergoing heparin-free hemodialysis (www.clinicaltrials.gov #NCT03612856). Patients were randomized to receive a single pre-dialysis dose of AB023 (0.25 or 0.5 mg/kg) or placebo in a 2:1 ratio and safety and preliminary efficacy were compared to placebo and to observations made prior to dosing within each treatment arm. AB023 administration was not associated with impaired hemostasis or other drug-related adverse events. Occlusive events requiring hemodialysis circuit exchange were less frequent and levels of thrombin-antithrombin complexes and C-reactive protein were lower after AB023 administration compared with data collected prior to dosing. AB023 also reduced potassium and iron entrapment in the dialyzers, consistent with less blood accumulation within the dialyzers. We conclude that despite the small sample size, inhibition of contact activation-induced coagulation with AB023 was well tolerated and reduced clotting within the dialyzer.

Anticoagulation Management for Impella Percutaneous Ventricular Assist Devices: An Analysis of a Single-Center Experience

2020 ◽  
Vol 54 (11) ◽  
pp. 1073-1082
Author(s):  
Ethan Wood ◽  
Charles Hayes ◽  
Anthony Hart
Keyword(s):  
Therapeutic Range ◽  
Major Bleeding ◽  
Small Sample Size ◽  
Small Sample ◽  
Ventricular Assist Devices ◽  
Patient Specific ◽  
Circulatory Support ◽  
Single Center ◽  
Bleeding Events ◽  
Anticoagulation Management

Background: Impella devices offer temporary mechanical circulatory support for cardiogenic shock. The manufacturer recommends systemic anticoagulation with a target activated clotting time of 160 to 180 s but provides no guidance on how to manage both the heparinized purge solution and the additional intravenous heparin needed to reach this therapeutic range. Previous publications demonstrated a lack of standardization in heparin management for Impella devices. Objective: The purpose of this study was to compare the effectiveness and safety of 2 different heparin protocols for long-term Impella support. Methods: This single-center, retrospective study included adult patients on Impella support for greater than 24 hours. The primary end point was time to therapeutic range measured in hours, from time of implantation to the first of 2 consecutive measurements within the therapeutic range. Secondary end points included percentage of time in therapeutic range, rates of major bleeding, pump thrombosis, hemolysis, and nursing satisfaction. Results: There were 19 patients identified, with 7 using the original protocol and 12 using the revised protocol. Time to therapeutic range was similar between protocols (15.5 vs 12 hours, P = NS). Another 14 patients were managed with patient-specific protocols as a result of bleeding or physician preference. In total, 42% of all patients in this study experienced major bleeding. There were no confirmed thrombosis events. This study was limited by a small sample size. Conclusion and Relevance: Despite using different heparin protocols, outcomes and bleeding events were similar between groups. Future studies are needed to determine the optimal degree of anticoagulation necessary to reduce bleeding risk.

Prevention of Early Arteriovenous Fistula Failure Due to Thromosis: Experience with Primary Thromboprophylaxis.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 885-885
Author(s):  
Anjali A. Sharathkumar ◽  
Jin-Jar Lin ◽  
Ronald Hirschl ◽  
Steven Pipe
Keyword(s):  
Sample Size ◽  
Arteriovenous Fistula ◽  
Small Sample Size ◽  
Small Sample ◽  
Bleeding Complications ◽  
Poor Growth ◽  
Group 2 ◽  
Associated Risk Factors ◽  
Stage Renal Disease ◽  
Historical Controls

Abstract Background: Arteriovenous fistula (AVF) is the preferred vascular access for children with end stage renal disease (ESRD) requiring hemodialysis. Once AVF is surgically created, it takes 6 to 12 weeks to mature. Nearly 20 to 50% of AVFs fail to mature due to development of primary or secondary thrombosis. Currently there is no uniform strategy to prevent the thrombosis at AVF. We report our experience of using primary thromboprophylaxis (PTP) for prevention of thrombosis at AVF. Methods & Results: A strategy of PTP constituted an infusion of unfractionated heparin (UFH, 10 IU/kg/hr) for the first 24 hours after AVF surgery followed by subcutaneous injection of low molecular weight heparin (LMWH, 0.5 to 1 mg/kg/dose) twice daily until AVF was matured and successfully accessed. LMWH therapy was monitored by peak and trough anti-Xa levels. Target anti-Xa levels were maintained in therapeutic range (0.5 to 1.0 IU/ml) for those with history of thrombosis or associated risk factors for thrombosis while remaining patients were maintained in prophylactic range (0.2 to 0.5 IU/ml). Trough anti-Xa level was aimed to be les than 0.2 IU/ml. Total of 26 AVF were performed on 18 children from January 2001 to July 2006: 19 (73%) historical controls; 7 (27%) received PTP. Mean time for AVF maturation was 60 days (range: 33 to 88). Among 19 children, 14 received no thromboprophylaxis while 5 received aspirin (81 mg once daily). Eleven (79%) of 14 AVF in no treatment group failed: 9/14 (65%) due to thrombosis, 2/14 (14%) due to poor growth of venous segment. Among 5 children who received aspirin prophylaxis, 2 (40%) AVFs failed, 1 (20%) developed hematoma and 1 (20%) had poor growth. In PTP group, 2/7 (29%) AVF failed: 1 due to hematoma, 1 due to poor growth. Additional events in PTP group included: vasospasm-induced thrombosis requiring thrombectomy (n=1) and hematoma (n=2, one was salvaged by surgical evacualtion). Two children who developed hematoma had anti-Xa levels at 1.56 IU/ml and 0.6 IU/ml respectively. Presently 4/7 (57%) AVFs in PTP group are functioning well (Figure 1). The 7th patient does not require hemodialysis. Three of the 5 children in the PTP group are still on LMWH (mean duration 6 months, mean anti-Xa level 0.6 IU/ml). Mean AVF survival was higher in children who received PTP (Day 100 survival: 57.14±18.7% versus 42.10±11.32% respectively; p 0.20; Figure 2). Small sample size thus far limits the meaningful statistical analysis. Conclusion: Our experience of LMWH thromboprophylaxis appears encouraging for prevention of AVF failure due to thrombosis. Close clinical and laboratory monitoring is required to prevent bleeding complications related to LMWH. More prospective data to expand our sample size will be required to clarify our observation. Institutional Experience of AVF from 2001 to 2006: Comparison between heparin thromboprophylaxis and historical controls D100 AVF survial: Comparison between thromboprophylaxis & historical controls D100 AVF survial: Comparison between thromboprophylaxis & historical controls

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