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Complication of Hemodialysis clinical trials

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NCT ID: NCT05425056 Recruiting - Clinical trials for End Stage Renal Disease

A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery

ACCESS2
Start date: August 26, 2022
Phase: Phase 3
Study type: Interventional

The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an arteriovenous fistula for hemodialysis vascular access.

NCT ID: NCT02950389 Completed - Clinical trials for Complication of Hemodialysis

REmoval of Free Light Chains. A COmpaRison of Three Different dialyzERs

RECORDER
Start date: January 2016
Phase: N/A
Study type: Interventional

Immunoglobulin light chains are classified as middle molecule uremic toxins able to interact with B lymphocyte membranes leading to the activation of transmembrane signaling. The ensuing impairment of neutrophil function can contribute to the chronic inflammation state of uremic patients, and the increased risk of bacterial infections or vascular calcifications. The aim of this crossover observational study was to assess the difference in free light chain removal by three different hemodialysis filters in patients not affected by multiple myeloma. Free light chain removal was compared in the polymethylmethacrylate (PMMA) membrane Filtryzer BK-F, the polyphenylene HFR17 filter and the conventional polysulfone filter F7 High Performance dialysers (HPS). Twenty chronic hemodialysis patients were enrolled. The patients were randomized into two groups of treatment lasting six weeks each. The dialysis sessions checked were the midweek sessions and the blood was drawn at times 0, 120' and 240'. Kappa (k) and lambda (l) light chain levels, beta2microglobulin (β2M), C reactive protein (CRP) and albumin were checked.

NCT ID: NCT02870829 Completed - Clinical trials for Vascular Calcification

Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K

TReVasc-HDK
Start date: July 2016
Phase: Phase 2
Study type: Interventional

The proposed study will seek to evaluate the prevalence and the progression of vascular calcification in a cohort of maintenance hemodialysis patients in Asian population. It will also evaluate the efficacy of vitamin K 2 supplementation in reducing the progression of vascular calcification in this group of patients. This will be a single-center randomized, prospective and open-label interventional clinical trial of end stage renal failure patients on hemodialysis.Primary outcome will be absolute difference in coronary artery calcium (CAC) score at 18-month between control and intervention arms. Secondary outcomes will be to compare absolute difference in aortic valve calcification, percentage of patients with regression of coronary artery calcification of at least 10%, absolute difference in aortic and systemic arterial stiffness, mortality from any cause and major adverse cardiovascular events (MACE) over the same period.

NCT ID: NCT02747966 Completed - Clinical trials for Complication of Hemodialysis

The Relationship Between the Flow of Arteriovenous Fistula and Cardiac Function in Haemodialysis Patients

Start date: April 2009
Phase: N/A
Study type: Observational

A prospective longitudinal surveillance for a period of 2 months. Sample - identify suitable Chronic Kidney Disease (CKD) patients who undergo HD with functioning AVF. Participants at various age range and both sexes are recruited to observe their access flow, access recirculation and cardiac function and assess their relationship.

NCT ID: NCT02558153 Completed - Clinical trials for Vascular Access Complication

RCT of Paclitaxel DEB Compared to Standard PTA in Dialysis Fistula

APERTO
Start date: June 2015
Phase: N/A
Study type: Interventional

A multicenter randomized clinical trial of paclitaxel drug-eluting balloon (DEB) versus standard percutaneous transluminal angioplasty (PTA) to reduce restenosis in 150 patients with haemodialysis access stenoses.

NCT ID: NCT02513303 Completed - Clinical trials for End Stage Renal Disease

Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes

ACCESS
Start date: November 2015
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index procedure).

NCT ID: NCT02446535 Recruiting - Uremia Clinical Trials

Probing the Dry Weight (DW) by Bioimpedance (BIA): Which is the Gold Standard Between Clinical DW and BIA DW?

REST
Start date: February 2015
Phase: N/A
Study type: Interventional

Background Very recently, a test aimed at assessing dry weight (DW) in hemodialysis (HD) patients has been developed, the "resistance stabilization test" (REST) Aim of the study To verify if BIA-based DW (BIA DW) control is truly superior to current volume management in HD patients. Protocol of the study DW determined with clinical methods (Clinical DW) is the gold standard by definition: Clinical DW is determined under strict clinical surveillance by the same attending physician. He will be helped by a clinical score of volume state about symptoms and signs of hypo- or hypervolemia. The physician is asked to adjust the DW of the candidates until their clinical score reaches zero before the BIA measurement. This Clinical DW will be compared with BIA DW, as obtained after performing REST Phases of the study The protocol study includes three sequential phases: 1. the Clinical DW is the gold standard by definition. Items of form B must be strictly applied until score = 0 is achieved; 2. The Clinical DW as indicated by the score = 0 becomes the target DW of the next standard HD session, in which BIA measurements are performed: R values are recorded continuously during the session. 3. REST is performed the following dialysis session. As per protocol, these dialysis sessions may be one or more than one, until flattening of the curve of the ratio R0/Rt (R0 is R at time 0 and Rt is R at a given time t during the HD session) of less than + 1% over 20 minutes in the presence of ongoing UF, is obtained. Primary outcome The primary outcome is the definition for each patient of the gold standard DW when comparing the Clinical and the BIA DW. Two are the possible scenarios: 1. the Clinical and the BIA DW will be very similar ( < + 0.5 kg). Therefore, a reciprocal validation of the two methods for that specific patient has been obtained; 2. the Clinical and the BIA DW are different ( > + 0.5 kg). If the BIA DW will be confirmed in the following six dialysis sessions, it means that the gold standard DW for that patient is the BIA DW.

NCT ID: NCT02443376 Completed - Clinical trials for Complication of Hemodialysis

The Effects of Hemodialysis Session on Vascular Stiffness

PWV/CP/HD
Start date: May 2015
Phase: N/A
Study type: Observational

Central blood pressure and pulse wave velocity were measured using a Complior Analyse device before and immediately after the end of the dialysis session.

NCT ID: NCT02263196 Recruiting - Clinical trials for Complication of Hemodialysis

The Efficacy of Alcohol After Betadine and Combination of Alcohol and Betadine on Inflammation Vascular Access

Start date: September 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study was to compare the efficacy of combination of alcohol and povidone iodine 10% and Alcohol 70% after povidone iodine 10% on inflammation and infection related to vascular access area in hemodialysis patients.

NCT ID: NCT01825590 Completed - Clinical trials for Complication of Hemodialysis

Effects of Simple Sodium Alignment on Clinical Outcomes

Start date: May 2011
Phase: N/A
Study type: Observational

A difference between dialysate and serum sodium concentration leads to diffusive sodium transfer across the dialyzer membrane. The consequences of diffusive sodium flux into the patient can be chronic sodium overload leading to overhydration, hypertension, cardiovascular disease, and other problems. Diffusive sodium flux out of the patient can lead to intradialytic blood pressure instability. A simple strategy for alignment of dialysate and serum sodium concentrations was implemented starting in April/May 2010 in order to minimize the problems particularly associated with chronic sodium overload.