Supervised preoperative forearm exercise to increase blood vessel diameter in patients requiring an arteriovenous access for hemodialysis: rationale and design of the PINCH trial

2018 ◽  
Vol 19 (1) ◽  
pp. 84-88 ◽  
Author(s):  
Esther D. Wilschut ◽  
Joris I. Rotmans ◽  
Ernst Jan Bos ◽  
Daniëlle van Zoest ◽  
Daniël Eefting ◽  
...  
Keyword(s):  
Blood Vessel ◽  
Controlled Trial ◽  
Ulnar Artery ◽  
Vessel Diameter ◽  
Success Rates ◽  
Dutch Version ◽  
Small Blood Vessel ◽  
Vessel Size ◽  
Forearm Exercise ◽  
Stage Renal Disease

Background: Failure of maturation occurs in 30%-60% of arteriovenous fistula (AVF) creation for hemodialysis, with highest rates in distal radiocephalic fistulas. This is partly due to initial small blood vessel size with limited blood flow capacity. Forearm exercise has shown potential as stimulus for increasing blood vessel size in patients with end-stage renal disease (ESRD) and may promote maturation of AVFs in the upper limb when applied postoperatively. However, it is unknown if forearm exercise increases blood vessel size pre-operatively, which may contribute to more distal AVF creation and raise success rates of AVF surgery. This study will investigate these issues. Methods and results: The PINCH trial (refers to ‘pinching’) is an investigator-initiated, multicenter, single-blinded, randomized controlled trial with 1:1 randomization to perform supervised forearm exercises compared to no exercise 6 weeks pre-operatively before creation of an AVF. Forty patients receiving an AVF will be included. The main study endpoints are blood vessel diameter (cephalic or basilic vein and radial and ulnar artery), AVF surgical plan (radiocephalic or brachiobasilic/cephalic), and three-month (assisted) maturation rate. The burden of the performed forearm exercises will be evaluated using Kidney Disease Quality of Life (KDQOL-SF Dutch version 1.2) and exercise specific questionnaires. The PINCH trial is planned to start in November 2017. Enrollment is expected to be completed at the end of 2019. Conclusions: The PINCH study is the first trial to evaluate the effect of pre-operative, supervised forearm exercises on vein diameter and fistula maturation in hemodialysis patients. Trial registration: NTR6382.

Roxadustat for anemia in patients with end-stage renal disease incident to dialysis

2021 ◽  
Author(s):  
Robert Provenzano ◽  
Evgeny Shutov ◽  
Liubov Eremeeva ◽  
Svitlana Korneyeva ◽  
Lona Poole ◽  
...  
Keyword(s):  
Rescue Therapy ◽  
Controlled Trial ◽  
Epoetin Alfa ◽  
Open Label ◽  
Treatment Groups ◽  
Intention To Treat ◽  
Primary Endpoints ◽  
Stage Renal Disease ◽  
End Stage ◽  
Event Rates

Abstract Background We evaluated the efficacy and safety of roxadustat vs. epoetin alfa for the treatment of chronic kidney disease (CKD) related anemia in patients new to dialysis. Methods This was a phase 3, open-label, epoetin alfa-controlled trial. Eligible adults were on hemodialysis/peritoneal dialysis for ≥2 weeks and ≤4 months before randomization and had mean hemoglobin ≤10.0 g/dL. Primary endpoints were mean hemoglobin (g/dL) change from baseline averaged over weeks 28–52 regardless of rescue therapy (non-inferiority criterion: lower limit of 95% CI for treatment difference > −0.75) and percentage of patients achieving a hemoglobin response between weeks 1–24 censored for rescue therapy (non-inferiority margin for between-group difference: −15%). Adverse events were monitored. Results The intention-to-treat population included patients randomized to roxadustat (n = 522) or epoetin alfa (n = 521). Mean (SD) hemoglobin changes from baseline averaged over weeks 28–52 were 2.57 (1.27) and 2.36 (1.21) in the roxadustat and epoetin alfa groups. Roxadustat was non-inferior (least-squares mean difference: 0.18 [95% CI: 0.08, 0.29]) to epoetin alfa. Percentages of patients with a hemoglobin response were 88.2% and 84.4% in the roxadustat and epoetin alfa groups. Roxadustat was non-inferior to epoetin alfa (treatment-group difference: 3.5% [95% CI: −0.7%, 7.7%]). Adverse event rates were comparable between treatment groups. Conclusions Roxadustat was efficacious for correcting and maintaining hemoglobin levels compared to epoetin alfa. Roxadustat had an acceptable safety profile.

scholarly journals A Prospective Multicenter Study of “Inside Stents” for Biliary Stricture: Multicenter Evolving Inside Stent Registry (MEISteR)

2021 ◽  
Vol 10 (13) ◽  
pp. 2936
Author(s):  
Hirofumi Kogure ◽  
Hironari Kato ◽  
Kazumichi Kawakubo ◽  
Hirotoshi Ishiwatari ◽  
Akio Katanuma ◽  
...  
Keyword(s):  
Multicenter Study ◽  
Stent Placement ◽  
Controlled Trial ◽  
Adverse Event Rate ◽  
Success Rates ◽  
Technical Success ◽  
Biliary Strictures ◽  
Prospective Multicenter Study ◽  
Stent Occlusion ◽  
Benign Biliary Strictures

Background: Endoscopic biliary stent placement is the standard of care for biliary strictures, but stents across the papilla are prone to duodenobiliary reflux, which can cause stent occlusion. Preliminary studies of “inside stents” placed above the papilla showed encouraging outcomes, but prospective data with a large cohort were not reported. Methods: This was a prospective multicenter registry of commercially available inside stents for benign and malignant biliary strictures. Primary endpoint was recurrent biliary obstruction (RBO). Secondary endpoints were technical success of stent placement and removal, adverse events, and stricture resolution. Results: A total of 209 inside stents were placed in 132 (51 benign and 81 malignant) cases with biliary strictures in 10 Japanese centers. During the follow-up period of 8.4 months, RBO was observed in 19% of benign strictures. The RBO rate was 49% in malignant strictures, with the median time to RBO of 4.7 months. Technical success rates of stent placement and removal were both 100%. The adverse event rate was 8%. Conclusion: This prospective multicenter study demonstrated that inside stents above the papilla were feasible in malignant and benign biliary strictures, but a randomized controlled trial is warranted to confirm its superiority to conventional stents across the papilla.

The Potential Cardiovascular Benefits of Low-Glucose Degradation Product, Biocompatible Peritoneal Dialysis Fluids: A Review of the Literature

2017 ◽  
Vol 37 (4) ◽  
pp. 375-383 ◽  
Author(s):  
Charlotte E. Grantham ◽  
Katherine L. Hull ◽  
Matthew P.M. Graham-Brown ◽  
Daniel S. March ◽  
James O. Burton
Keyword(s):  
Risk Factors ◽  
Peritoneal Dialysis ◽  
Cardiovascular Risk ◽  
Interstitial Fibrosis ◽  
Degradation Products ◽  
Controlled Trial ◽  
Membrane Integrity ◽  
Left Ventricular ◽  
Stage Renal Disease ◽  
End Stage

Cardiovascular mortality in the end-stage renal disease (ESRD) population remains the leading cause of death. Targeting traditional cardiovascular risk factors has proven unsuccessful in this patient population, and therefore attention has turned to risk factors related to chronic kidney disease (CKD). The toxicity of high-glucose peritoneal dialysis (PD) solutions has been well documented. The breakdown of glucose into glucose degradation products (GDP) and advanced glycation end-products (AGE) has the ability to alter cell viability and cause premature apoptosis and is strongly correlated with interstitial fibrosis and microvascular sclerosis. Biocompatible solutions have been introduced to combat the hostile milieu to which PD patients are exposed.Given the considerable cardiovascular burden for PD patients, little is known about the cardiovascular impact the new biocompatible solutions may have. This review analyzes the existing literature regarding the mechanisms through which low-GDP solutions may modulate cardiovascular risk. Interventions using low-GDP solutions have provided encouraging changes in structural cardiovascular measures such as left ventricular mass (LVM), although metabolic changes from reduced GDP and AGE exposure yield inconclusive results on vascular remodelling. It is thought that the local effects of reduced glucose exposure may improve membrane integrity and therefore fluid status. Further research in the form of a robust randomized controlled trial should be carried out to assess the true extent of the cardiovascular benefits these biocompatible solutions may hold.

scholarly journals Landmark-guided Versus Modified Ultrasound-assisted Paramedian Techniques in Combined Spinal-epidural Anesthesia for Elderly Patients with Hip Fractures: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Bo Qu ◽  
Luying Chen ◽  
Yuling Zhang ◽  
Mengting Jiang ◽  
Caineng Wu ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Success Rate ◽  
Hip Fractures ◽  
Controlled Trial ◽  
Median Number ◽  
Needle Insertion ◽  
Success Rates ◽  
First Pass ◽  
Ultrasound Assisted ◽  
Ultrasound Group

Abstract Background: Combined spinal-epidural (CSE) anesthesia is considerably challenging for elderly patients with hip fractures due to spine degeneration and limitations in positioning. This study aimed to investigate the ability of a modified preprocedural ultrasound-guided technique to improve the success rate and efficacy of CSE anesthesia for elderly patients with hip fractures. Methods: This prospective, single-blinded, parallel-group randomized controlled trial included 80 patients (aged ≥ 65 years) who were scheduled for elective hip fracture surgery with CSE anesthesia. Patients were randomly allocated into landmark group (n = 40) or the ultrasound group (n = 40). The primary outcome was first-pass success rate. Secondary outcomes included first-attempt success rate; number of needle insertion attempts; number of needle passes; locating, puncture, and total time; level of block; procedural adverse reactions and postoperative complications; and patient satisfaction score. Patients were blinded to group allocation.Results: 80 patients completed the study and were included in the final analysis. The first-pass success rates for the landmark and ultrasound groups were 20% and 70%, respectively (P < 0.001). The first-attempt success rates in the landmark and ultrasound groups were 42.5% and 85%, respectively (P < 0.001). The median number of attempts was lower in ultrasound-assisted group (1[1,1]) than landmark-guided group (2[1,2]), P < 0.001). The median number of needle passes was lower in ultrasound group (1[1,2]) than in landmark-guided group (3[2,4], P < 0.001). The locating time (P < 0.001) and total time (P = 0.001) were longer in the ultrasound group, while puncture time was shorter (P = 0.003). No significant difference was found regarding the incidence of adverse reactions and complications. More patients in the ultrasound group had a high satisfaction score of 4–5 (P = 0.007). Interestingly, subgroup analysis demonstrated benefits for ultrasound in patients with scoliosis.Conclusions: Modified ultrasound-assisted CSE anesthesia increases first-pass and first-attempt success rates, and reduces needle insertion attempts, passes, and puncture time for elderly patients with hip fracture, especially those with scoliosis. This technique improves patient satisfaction and warrants consideration for application in clinical practice.Trial registration: Chinese Clinical Trial Register (identifier, ChiCTR1900020819; date of registration, January 20, 2019).

scholarly journals Anticoagulation in Patients with End-Stage Renal Disease and Atrial Fibrillation: Confusion, Concerns and Consequences

2020 ◽  
Vol 22 (3) ◽  
pp. 306-316
Author(s):  
Narender Goel ◽  
Deepika Jain ◽  
Danny B. Haddad ◽  
Divya Shanbhogue
Keyword(s):  
Atrial Fibrillation ◽  
Renal Disease ◽  
End Stage Renal Disease ◽  
Clinical Decision Making ◽  
Controlled Trial ◽  
Oral Anticoagulants ◽  
Increased Risk ◽  
Stage Renal Disease ◽  
End Stage ◽  
Esrd Patients

End-stage renal disease (ESRD) patients have a higher prevalence of diabetes mellitus, hypertension, congestive heart failure and advanced age, along with an increased incidence of non-valvular atrial fibrillation (AF), thereby increasing the risk for cerebrovascular accidents. Systemic anticoagulation is therefore recommended in patients with ESRD with AF to reduce the risk and complications from thromboembolism. Paradoxically, these patients are at an increased risk of bleeding due to great degree of platelet dysfunction and impaired interaction between platelet and endothelium. Currently, CHA2DS2-VASc and Hypertension, Abnormal liver/kidney function, Stroke, Bleeding, Labile INR, Elderly, Drugs or alcohol (HAS-BLED) are the recommended models for stroke risk stratification and bleeding risk assessment in patients with AF. There is conflicting data regarding benefits and risks of medications such as antiplatelet agents, warfarin and direct oral anticoagulants in ESRD patients with AF. Moreover, there is no randomized controlled trial data to guide the clinical decision making. Hence, a multi-disciplinary approach with annual re-evaluation of treatment goals and risk-benefit assessment has been recommended. In this article, we review the current recommendations with risks and benefits of anticoagulation in patients with ESRD with AF.

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