scholarly journals Substitution of Citrate with Tissue Plasminogen Activator (rt-PA) for Catheter Lock Does Not Improve Patency of Tunneled Hemodialysis Catheters in a Randomized Trial

2020 ◽  
Author(s):  
Pavlina Richtrova ◽  
Jan Mares ◽  
Lukas Kielberger ◽  
Jan Klaboch ◽  
Jaromir Eiselt ◽  
...  
Keyword(s):  
Blood Flow ◽  
Statistical Significance ◽  
Trisodium Citrate ◽  
Time Interval ◽  
Hemodialysis Catheter ◽  
Post Hoc Analysis ◽  
Catheter Malfunction ◽  
Catheter Lock ◽  
Post Hoc ◽  
Previous Session

Abstract Background: The study aim was to establish if substitution of citrate with rt-PA for catheter lock once weekly can reduce the incidence of catheter-related blood stream infections (CR-BSI) or improve patency of tunneled hemodialysis catheters.Methods: All incident patients undergoing insertion of a tunneled hemodialysis catheter were screened and included except those suffering infection or using oral anticoagulation. Study participants were randomized into two arms according to the solution applied as catheter lock: receiving either trisodium citrate (Citra-LockTM 4%) only or rt-PA (Actilyse® 1mg/ml) on the middle session each week with citrate used on the first and third sessions. The incidence of CR-BSI (confirmed by positive blood culture), catheter non-function (complete obstruction), and malfunction (blood flow <250ml/min) was recorded. Statistical significance was tested with ANOVA, post hoc analysis was performed by means of multiple linear regression.Results: Totally, 18 patients were included and followed during 655 hemodialysis sessions. No episode of CR-BSI was detected while 6 catheter non-functions (0.9% sessions) and 101 malfunctions (15.4% sessions) were recorded. The incidence of both events was equal between the study arms: 4 non-functions and 55 malfunctions in the rt-PA arm and 2 non-functions and 46 malfunctions in the citrate arm (p=0.47 and p=0.24, respectively). Additionally, the mean blood flow achieved did not differ significantly between the arms: 326±1,8 and 326±1,9 ml/min (p=0.95) in rt-PA and citrate arms, respectively. Post hoc analysis identified time elapsed since previous session (β=0.12, p=0.005) and malfunction on previous session (β=0.25, p<0.001) as significant factors affecting the occurrence of malfunction. By contrast, the study arm, rt-PA application on previous session, and catheter vintage did not enter the model.Conclusion: Substitution of citrate with rt-PA for catheter lock does not reduce the incidence of catheter malfunction neither does it affect the blood flow achieved during hemodialysis. Catheter patency is related rather to the time interval between sessions and to previous malfunction (thus probably reflecting undefined individual factors). The incidence of CR-BSI within pre-selected hemodialysis population is sporadic (less than 1 per 4.3 patient years in our sample).Trial registration: The study was registered on the ACTRN 12612000152820

scholarly journals Substitution of citrate with tissue plasminogen activator (rt-PA) for catheter lock does not improve patency of tunnelled haemodialysis catheters in a randomised trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Pavlina Richtrova ◽  
Jan Mares ◽  
Lukas Kielberger ◽  
Jan Klaboch ◽  
Jaromir Eiselt ◽  
...  
Keyword(s):  
Blood Flow ◽  
Statistical Significance ◽  
Randomised Trial ◽  
Time Interval ◽  
Haemodialysis Catheter ◽  
Post Hoc Analysis ◽  
Catheter Malfunction ◽  
Catheter Lock ◽  
Post Hoc ◽  
Previous Session

Abstract Backround The study aim was to establish if substitution of citrate with rt-PA for catheter lock once weekly can reduce the incidence of catheter-related blood stream infections (CR-BSI) or improve patency of tunneled haemodialysis catheters. Methods All incident patients undergoing insertion of a tunneled haemodialysis catheter were screened and included except those suffering infection or using oral anticoagulation. Study participants were randomized into two arms according to the solution applied as catheter lock: receiving either trisodium citrate (Citra-LockTM 4%) only or rt-PA (Actilyse® 1 mg/ml) on the middle session each week with citrate used on the first and third sessions. The incidence of CR-BSI (confirmed by positive blood culture), catheter non-function (complete obstruction), and malfunction (blood flow < 250 ml/min) was recorded. Statistical significance was tested with ANOVA, post hoc analysis was performed by means of multiple linear regression. Results Totally, 18 patients were included and followed during 655 haemodialysis sessions. No episode of CR-BSI was detected while 6 catheter non-functions (0.9% sessions) and 101 malfunctions (15.4% sessions) were recorded. The incidence of both events was equal between the study arms: 4 non-functions and 55 malfunctions in the rt-PA arm and 2 non-functions and 46 malfunctions in the citrate arm (p = 0.47 and p = 0.24, respectively). Additionally, the mean blood flow achieved did not differ significantly between the arms: 326 ± 1,8 and 326 ± 1,9 ml/min (p = 0.95) in rt-PA and citrate arms, respectively. Post hoc analysis identified time elapsed since previous session (β = 0.12, p = 0.005) and malfunction on previous session (β = 0.25, p < 0.001) as significant factors affecting the occurrence of malfunction. By contrast, the study arm, rt-PA application on previous session, and catheter vintage did not enter the model. Conclusion Substitution of citrate with rt-PA for catheter lock does not reduce the incidence of catheter malfunction neither does it affect the blood flow achieved during haemodialysis. Catheter patency is related rather to the time interval between sessions and to previous malfunction (thus probably reflecting undefined individual factors). The incidence of CR-BSI within pre-selected haemodialysis population is sporadic (less than 1 per 4.3 patient years in our sample). Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12612000152820. Retrospectively registered 03/02/2012.

scholarly journals Influence of Foot Orthotics and Intrinsic Factors on Strain Measurements in the Fifth Metatarsal

2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0025
Author(s):  
Jeffrey W. Hoffman ◽  
Rogerio C. Bitar ◽  
Daniel R. Sturnick ◽  
Glenn Garrison ◽  
Constantine A. Demetracopoulos ◽  
...  
Keyword(s):  
Risk Factors ◽  
Repeated Measures ◽  
Statistical Significance ◽  
Return To Play ◽  
Peak Strain ◽  
Lateral Plate ◽  
Intrinsic Factors ◽  
Post Hoc Analysis ◽  
Zone Ii ◽  
Post Hoc

Category: Midfoot/Forefoot; Sports Introduction/Purpose: Fractures of the fifth metatarsal occur in young, athletic populations and often result in sub-optimal clinical outcomes, even after surgical fixation. With such a high demand for decreased return to play in athletic populations, the development of intervention strategies which mitigate intrinsic and extrinsic risk factors of initial injury is important. Foot orthotics have been shown to decrease strain in the 2nd metatarsal. However, limited research has investigated the influence of intrinsic risk factors and the use of foot orthotics on fifth metatarsal strain. Therefore, the purpose of our study was to investigate the effect of foot orthotics and intrinsic risk factors on fifth metatarsal strain during cadaveric simulation. Methods: Ten specimens were loaded to simulate the stance phase of normal gait using a validated 6-degree of freedom robot with tendon actuators. Strain gauges were placed at the metaphyseal - diaphyseal junction (Zone II), and the proximal diaphysis (Zone III) to measure principal strain. Specimens were tested in a sneaker-only control condition and ten orthotic conditions, which include combinations of a commercial orthotic insole, three plates, and two foam wedges (Figure 1A). The average peak strain from three simulations were recorded for each orthotic condition. Relevant intrinsic factors were recorded from reconstructions of axially loaded computed tomography scans. A two-way repeated measures ANOVA was conducted to determine the effect of orthotic conditions on fifth metatarsal strains, with significantly correlated intrinsic factors included as covariates. Tukey-Kramer post-hoc analysis with a Bonferroni correction was used to analyze differences between individual orthotic conditions and main effects of components. Results: Metatarsus adductus angle, 4-5 intermetatarsal angle, and Meary’s angle (R2= 0.944; p<0.001) were included as covariates in analysis of Zone III strain. Significant (p<0.05) differences in Zone III strain were found for the both the main effect of a plate and individual orthotic cond itions with statistical adjustment for previously stated intrinsic measurements. However, post- hoc testing revealed no significant differences between non-plate conditions and full plate conditions(p=0.23), lateral plate conditions (p=0.025), or lateral cut plate conditions (p=0.026). Additionally, the Full Plate with Lateral Wedge condition reduced strains by 285 µΕ relative to the sneaker condition, no significant differences (p = 0.07) were found in post-hoc analysis. No significant differences were found in Zone II with the models considered. Conclusion: Zone III strains were shown to be significantly correlated with intrinsic factors in the current analysis. Plate conditions demonstrated a trend towards significant reduction of Zone III strain relative to the sneaker condition, despite failing to achieve statistical significance in conservative post-hoc analysis. However, these results may be clinically significant as the reduction of strain in plate conditions exceeded previously reported significant decreases in the 2nd metatarsal. Correlations found between intrinsic risk factors and strain in this study corroborate with previous studies. This indicates that the effectiveness of foot orthotics to reduce strain is strongly influenced by individual foot structure.

Landmark analysis of overall survival (OS) by objective response (OR) in previously treated patients (pts) with advanced hepatocellular carcinoma (aHCC): Post hoc analysis of the randomized, phase 3 KEYNOTE-240 study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16122-e16122
Author(s):  
Andrew X. Zhu ◽  
Stéphane Cattan ◽  
Philippe Merle ◽  
Bruno Daniele ◽  
Stephen Lam Chan ◽  
...  
Keyword(s):  
Proportional Hazards Model ◽  
Statistical Significance ◽  
Objective Response ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Advanced Hepatocellular Carcinoma ◽  
Landmark Analysis ◽  
Post Hoc Analysis ◽  
Landmark Analyses ◽  
Post Hoc

e16122 Background: Studies have shown that OR is prognostic of OS in pts with HCC. KEYNOTE-224 (NCT02702414) evaluated pembrolizumab (pembro; anti–PD-1) in sorafenib (sora)-treated pts with aHCC and showed an ORR of 17% that was durable in responders receiving pembro, ultimately leading to FDA approval. In KEYNOTE-224, a landmark analysis showed that OR in pembro-treated pts was prognostic of longer OS. The KEYNOTE-240 (NCT02702401) study evaluated pembro + best supportive care (BSC) vs placebo (pbo) + BSC in sora-treated pts with aHCC. Although clinical benefit was observed in KEYNOTE-240 with pembro vs pbo, prespecified statistical significance criteria for OS and PFS were not met. This post hoc analysis of KEYNOTE-240 was performed to determine whether OR at landmark is prognostic of longer survival after landmark time. Methods: Eligible pts were aged ≥18 y, had confirmed aHCC, and experienced progression during or after sora treatment or intolerance to sora. Landmark analyses of OS according to OR at 6, 12, and 18 wk after randomization were performed on the pembro arm to evaluate the association between survival after the landmark with response achieved before the landmark. OR was assessed by blinded independent central review per RECIST v1.1. Responders at each landmark were defined as pts with any response assessment of CR or PR before the landmark date; all other pts were defined as nonresponders. HR and 95% CI for survival after the landmark were calculated from the Cox proportional hazards model using Efron method of tie handling, with responder status as a single covariate. Analysis was performed on the ITT population. Results: As of Jan 2, 2019, median time from randomization to data cutoff was 21.2 mo (range 13.4-30.4) for pembro. In the pembro arm, 51 pts (18.3%) had a best OR of CR or PR and 6 pts (4.4%) in the pbo arm had a best OR of PR (no CR) (excluded from landmark analyses). OS after landmark time was longer for responders than nonresponders at the wk 6, 12, and 18 time points (Table). The HR for OS after landmark time for responders vs nonresponders was 0.37 (95% CI 0.18-0.75), 0.39 (95% CI 0.23-0.66), and 0.37 (95% CI 0.21-0.63) at wk 6, 12, and 18, respectively. Conclusions: This post hoc analysis showed that pts with sora-treated aHCC who achieved OR by landmark time with pembro have longer OS after the landmark time, confirming the prognostic association between OR with pembro and OS observed in KEYNOTE-224. Clinical trial information: NCT02702401. [Table: see text]

scholarly journals Effect of health education on knowledge and attitude of menopause among middle-age teachers

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Helen Gebretatyos ◽  
Lidia Ghirmai ◽  
Soliana Amanuel ◽  
Ghidey Gebreyohannes ◽  
Zemenfes Tsighe ◽  
...  
Keyword(s):  
Health Education ◽  
Educational Intervention ◽  
Statistical Significance ◽  
Post Intervention ◽  
Post Hoc Analysis ◽  
Time Points ◽  
The Mean ◽  
Knowledge And Attitude ◽  
Post Hoc

Abstract Background Adequate knowledge and positive attitude toward menopause are important for women to tackle changes related to menopause. Even though all women experience menopause at some stage in their life, teachers face more difficulties more than other female employees due to the nature of their roles do. In Eritrea, menopause has been given little attention hence gaps exist concerning women’s knowledge, attitude, and the effects of health education on the same subject. This study aimed at assessing the effect of health education on knowledge and attitude of menopause among middle-aged teachers in elementary, junior, and secondary schools of Asmara, Eritrea. Method A semi-experimental design with pre-intervention, immediate post-intervention, and three-month follow up test was used in this study. The data was collected from 99 middle age teachers using stratified random sampling. The intervention was done using lectures, group discussions, brochures, and handouts. Data on socio-demographics, knowledge, and attitude was collected using a pre-designed questionnaire. The effect of educational training at the three-time points was evaluated by repeated measure ANOVA using SPSS version 22. Results The mean scores of correct knowledge at pre-intervention, immediate post-intervention, and 3-months follow-up were 12.3/22 (SD = 3.06), 17.3/22 (SD = 3.21), and 16.5/22 (SD = 2.52) respectively. A significant difference in scores of knowledge at the three-time points was observed due to the educational intervention with a statistical significance of (p <  0.0001). Post-hoc analysis revealed that knowledge score immediately after intervention was significantly greater than that of pre-intervention (p <  0.0001), and 3-months follow-up (p = 0.004). The mean scores of attitude at the three-time points were 27.9/45 (SD = 5.14), 28.3/45(SD = 5.25), 28.32/45(SD = 5.12). The educational intervention had brought a change in the mean scores of attitude at the three-time point with a statistical significance of (p < 0.0001). Post-hoc analysis revealed that attitude scores at immediate post-intervention were also significant (p = 0.001) with the 3-months follow up at (p < 0.0001) were higher than that of pre-intervention. Conclusion The structured educational intervention was beneficial to the studied women in intensifying their knowledge and tuning them toward a positive attitude. Hence, proper health education programs regarding menopause are strongly recommended.

scholarly journals Different glomerular filtration rate estimating formula for prescribing DOACs in oldest patients: appropriate dosage and bleeding risk. Post hoc analysis of a prospective cohort

2021 ◽  
Author(s):  
Valeria Calsolaro ◽  
Chukwuma Okoye ◽  
Sara Rogani ◽  
Alessia Maria Calabrese ◽  
Umberto Dell’Agnello ◽  
...  
Keyword(s):  
Glomerular Filtration Rate ◽  
Glomerular Filtration ◽  
Cystatin C ◽  
Prospective Cohort ◽  
Filtration Rate ◽  
Statistical Significance ◽  
Bleeding Risk ◽  
Post Hoc Analysis ◽  
Ckd Stage ◽  
Post Hoc

Abstract Background Direct oral anticoagulants (DOACs) pharmacokinetics depends on estimated glomerular filtration rate (eGFR), whose estimation is crucial for optimal risk/benefit balance. Aims To assess the concordance among different eGFR formulas and the potential impact on DOACs prescription appropriateness and bleeding risk in oldest hospitalized patients. Methods Post hoc analysis of a single-centre prospective cohort study. eGFR was calculated by creatinine-based (MDRD, CKD-EPICr, BIS1) and creatinine–cystatin-C-based (CKD-EPIComb and BIS2) formulas. Patients were stratified according to eGFR [severely depressed (SD) 15–29; moderately depressed (MD) 30–49; preserved/mildly depressed (PMD): ≥ 50 ml/min/1.73 m2]. Concordance between the different equations was assessed by Cohen’s kappa coefficient. Results Among AF patients, 841 (59.2% women, mean age 85.9 ± 6.5 years) received DOACs. By CKD-EPICr equation, 135 patients were allocated in the SD, 255 in the MD and 451 in the PMD group. The concordance was excellent only between BIS 2 and CKD-EPIComb and MDRD and CKD-EPICr, while was worse (from good to poor) between the other formulas. Indeed, by adding cystatin-C almost over 1/3 of the patients were reallocated to a worse eGFR class. Bleeding prevalence increased by 2–3% in patients with discordant eGFR between formulas, reallocated to a worse chronic kidney disease (CKD) stage, although without reaching statistical significance. CKD-EPIComb resulted the best predictor of bleeding events (AUROC 0.71, p = 0.03). Discussion This study highlights the variability in CKD staging according to different eGFR formulas, potentially determining inappropriate DOACs dosing. Although the cystatin-C derived CKDEPIComb equation is the most accurate for stratifying patients, BIS1 may represent a reliable alternative.

scholarly journals SuO011DOPPLER ULTRASOUND VS TRANSONIC FOR ACCESS BLOOD FLOW BASED SURVEILLANCE. POST-HOC ANALYSIS FROM METTRO TRIAL. NCT02111655

2018 ◽  
Vol 33 (suppl_1) ◽  
pp. i620-i620
Author(s):  
Ines Aragoncillo ◽  
Silvia Caldes ◽  
Soraya Abad ◽  
Yesika Amezquita ◽  
Almudena Vega ◽  
...  
Keyword(s):  
Blood Flow ◽  
Post Hoc Analysis ◽  
Post Hoc

scholarly journals The Clinical Impact of Hexanic Extract of Serenoa repens in Men with Prostatic Inflammation: A Post Hoc Analysis of a Randomized Biopsy Study

2020 ◽  
Vol 9 (4) ◽  
pp. 957
Author(s):  
Michael Samarinas ◽  
Anastasios Karatzas ◽  
Vasileios Tzortzis ◽  
Stavros Gravas
Keyword(s):  
Statistical Significance ◽  
Maximum Flow ◽  
Clinical Impact ◽  
Control Group ◽  
Serenoa Repens ◽  
Therapy Assessment ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
To Receive ◽  
Prostatic Inflammation

A randomized biopsy study showed that hexanic Serenoa repens (HESr) treatment resulted in prostatic inflammation reduction. This post-hoc analysis evaluated the clinical impact of HESr and investigated correlations between baseline parameters and treatment response. Patients were randomized to receive HESr 320mg/day for six months or no therapy. Assessment included International Prostate Symptoms Score (IPSS), prostate volume (PV), and maximum flow rate (Qmax). Baseline characteristics were recorded, including body mass index (BMI) and metabolic syndrome (MetS) components. In patients under α1-adrenoceptor antagonists (α1-blockers), the addition of HESr resulted in statistically significant IPSS improvement after 6 months (p = 0.006). IPSS remained stable in patients under a1-blockers only (p = 0.346). Patients treated only with HESr reported a significant IPSS amelioration (p = 0.001). In the control group of naïve patients, no significant IPSS change was detected (p = 0.298). Baseline PV showed fair correlation (r = −0.20) with inflammation reduction in the HESr patients. BMI (r = 0.40), diabetes mellitus (r = 0.40), and PV (r = 0.23) showed fair correlation with Qmax increase but without reaching statistical significance. MetS (p = 0.06) was an influent biomarker for Qmax improvement. Treatment with HESr (as monotherapy or add-on therapy to a-blockers) may improve urinary symptoms in terms of IPSS in patients with prostatic inflammation.

Landmark analysis of overall survival (OS) by objective response (OR) in previously treated patients (pts) with advanced hepatocellular carcinoma (aHCC): Post-hoc analysis of the randomized, phase III KEYNOTE-240 study.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 318-318
Author(s):  
Julien Edeline ◽  
Stéphane Cattan ◽  
Philippe Merle ◽  
Bruno Daniele ◽  
Stephen Lam Chan ◽  
...  
Keyword(s):  
Statistical Significance ◽  
Objective Response ◽  
Response Assessment ◽  
Best Supportive Care ◽  
Phase Iii ◽  
Advanced Hepatocellular Carcinoma ◽  
Landmark Analysis ◽  
Post Hoc Analysis ◽  
Landmark Analyses ◽  
Post Hoc

318 Background: Studies have shown that OR is prognostic of OS in pts with HCC. KEYNOTE (KN)-224 (NCT02702414) evaluated pembrolizumab (pembro; anti-PD-1) in sorafenib (sora)-treated pts with aHCC and demonstrated an OR rate of 17% that was durable in responders receiving pembro, ultimately leading to its FDA approval. In KN-224, a landmark analysis showed that OR in pembro-treated pts was prognostic of longer OS. The KN-240 (NCT02702401) study evaluated pembro + best supportive care (BSC) vs placebo (pbo) + BSC in sora-treated pts with aHCC. Although clinical benefit was observed in KN-240 with pembro vs pbo, prespecified statistical significance criteria for OS and PFS were not met. This post hoc analysis of KN-240 was performed to determine whether OR at landmark is prognostic of longer survival after landmark time. Methods: Eligible pts were aged ≥18 y, had confirmed aHCC, and experienced progression during or after sora treatment or intolerance to sora. Landmark analyses of OS according to OR at 6, 12, and 18 wk after randomization were performed on the pembro arm to examine the association between survival after the landmark with response achieved prior to the landmark. OR was assessed by blinded independent central review per RECIST v1.1. Responders at each landmark were defined as pts with any response assessment of CR or PR before the landmark date; all other pts were defined as nonresponders. HRs and 95% CIs for survival after the landmark were calculated from the Cox proportional model with Efron’s method of tie handling with responder status as a single covariate. Analyses were performed in the ITT population. Results: As of Jan 2, 2019, the median time from randomization to data cutoff was 21.2 months (range 13.4-30.4) for pembro. There were 51 pts (18.3%) with a BOR of CR or PR in the pembro arm and 6 pts (4.4%) with a BOR of PR (no CR) in the pbo arm (excluded from landmark analyses). OS after landmark time was longer for responders compared with nonresponders at the wk 6, 12, and 18 time points (Table). The HR for OS after landmark time for responders versus nonresponders were 0.37 (95% CI 0.18-0.75), 0.39 (95% CI 0.23-0.66), and 0.37 (95% CI 0.21-0.63) at wk 6, 12, and 18, respectively. Conclusions: This post hoc analysis demonstrates that pts with sora-treated aHCC who achieve OR by landmark time with pembro have longer OS after the landmark time, confirming the prognostic association between OR with pembro and OS observed in KN-224. Clinical trial information: NCT02702401. [Table: see text]

Ethanol/Trisodium citrate for hemodialysis catheter lock

2004 ◽  
Vol 62 (11) ◽  
pp. 369-373 ◽  
Author(s):  
A.L. Bell ◽  
X. Gu ◽  
F.J. Burczynski ◽  
L.M. Vercaigne
Keyword(s):  
Trisodium Citrate ◽  
Hemodialysis Catheter ◽  
Catheter Lock
Sign in / Sign up

Export Citation Format

Share Document