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Hemodialysis Complication clinical trials

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NCT ID: NCT04681521 Completed - Fatigue Clinical Trials

Hot and Cold Compress in Hemodialysis

Start date: February 1, 2020
Phase: N/A
Study type: Interventional

Aims and objectives. To examine and compare the effects of hot and cold compresses administration on muscle cramps, fatigue, and comfort in hemodialysis (HD) patients. Background. Muscle cramps and fatigue are common complications in HD patients and reduce patient comfort. Among the nursing interventions stated for the management of these complications in the literature, hot and cold therapy are remarkable. To the best of our knowledge, the present study is the first research up to date that examined and compared the effects of hot and cold compress administrations on abovementioned complications in HD. Design. This placebo-controlled randomized trial was conducted in two hemodialysis centers between February and October 2020. Methods. The study sample consisted of 69 patients, stratified and randomly allocated to two intervention groups and placebo group. For patients of each group, the implementation of the study continued for four weeks, 12 HD sessions.

NCT ID: NCT04645121 Completed - Clinical trials for Hemodialysis Complication

Carbon Monoxide-based Rebreathing Method and Bioimpedance in Hemodialysis Patients

HEMOVOL
Start date: November 25, 2020
Phase:
Study type: Observational

The study is a case-control study with the primary aim of objectifying the volume status of patients receiving hemodialysis. Volume status will be assessed at dry weight and evaluated by a carbon monoxide rebreathing method, that measures blood volume, and bioimpedance that measures total body water. Case-control subjects will be matched on gender, age and weight. Secondary aims are to evaluate the carbon monoxide rebreathing method. Blood volumes obtained by the carbon monoxide rebreathing method will be correlated to blood volumes obtained by radioactive labelling of erythrocytes and albumin. In addition, it will be investigated whether hemoglobin is a valid marker of anemia in patients receiving hemodialysis by measuring the erythrocyte volume and the hemoglobin mass by the carbon monoxide rebreathing method and correlating this to the hemoglobin concentration measured before and after dialysis.

NCT ID: NCT04381234 Completed - Clinical trials for Hemodialysis Complication

Strategies for Asymmetrical Triacetate Dialyzer Heparin-Free Effective Hemodialysis

SAFE
Start date: January 6, 2018
Phase: Phase 2
Study type: Interventional

Not all dialysis patients tolerate heparin anticoagulation. Heparin should be avoided in patients at high risk of bleeding. Strategies include saline infusion, citrate-containing dialysate, regional citrate anticoagulation and heparin-coated membranes. We recently studied the combination of a heparin-coated membrane and citrate-containing dialysate, with a success rate of 94% . Although this combination resulted in low rates of clotting, heparin-coated membranes are not ubiquitously available. The quest for easy to perform, safe and affordable heparin-free dialysis is on. Asymmetric cellulose triacetate (ATA) dialyzers have a low degree of platelet contact activation and might be an alternative to heparin-coated dialyzers. This is a phase II pilot study in maintenance dialysis patients. Study design is a two-arm open-label cross-over study. In Arm 1, patients were dialyzed using a 1.9 m2 ATA membrane (Solaceaâ„¢-19H, Nipro Corp., Japan) in combination with citrate (1 mM) containing dialysate. In Arm 2, patients were dialyzed with the same 1.9 m2 ATA membrane, in combination with high volume predilution hemodiafiltration. The primary endpoint was the success rate to complete 4 hours of hemodialysis without preterm clotting.

NCT ID: NCT04319328 Completed - Clinical trials for End Stage Renal Disease

Is Cefazolin, Ceftazidime and Ciprofloxacin Dosing Optimal in Hemodialysis Patients?

Start date: October 18, 2019
Phase:
Study type: Observational

This study aims to optimize the dosing of cefazolin, ceftazidime, and ciprofloxacin for patients on high-flux hemodialysis. For each antibiotic 20 participants will be enrolled and three blood samples will be collected from each participant. Antibiotic levels will be measured in each blood sample. This data will be used to develop population-pharmacokinetic models for each antibiotic. Finally, Monte Carlo simulations will be used to develop evidence-based dosing recommendations.

NCT ID: NCT04299256 Completed - Fatigue Clinical Trials

Benson Relaxation Technique Combined With Music Therapy for Fatigue, Anxiety, and Depression in Hemodialysis Patients

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

This study carried out in the HD unit of a large-scale training and research hospital, and at a dialysis center associated with this hospital located in Ankara, Turkey. Participants will be randomized to one of two study arms. Arm 1: Intervention group Arm 2: Control group Hypothesis 1. The HD patients in the 8-week intervention of BRT combined with music therapy will report lower fatigue scores than those in the control group. Hypothesis 2. The HD patients in the 8-week intervention of BRT combined with music therapy will perceive lower anxiety and depression than those in the control group.

NCT ID: NCT04268264 Completed - Renal Failure Clinical Trials

A Feasibility Study to Test the Acceptability, Tolerance and Safety of Incremental Haemodialysis

ENDURE
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

This feasibility study tests if patients find incremental HD acceptable, whether they tolerate the treatment as planned and to evaluate its safety. Over a period of 18-months, 20 participants will be recruited in to the study who are about to start HD therapy for ESRD. The participants will start HD incrementally (incremental HD group) reaching full dose HD over a period of approximately 15 weeks. The outcomes will be compared to a cohort of 40 matched patients who previously started HD in the conventional manner (historical controls, conventional HD group). All patients will be followed-up for 6 months after first dialysis. Participants will be reviewed regularly during this time, and will undergo laboratory and bed-site monitoring tests. Acceptability and tolerance will be tested by documenting the numbers and percentages of patients who agree to participate and continue in the study. Patients who decline the invitation to join the study will be given the opportunity to express their reasons for declining to go on incremental HD (they will not play further part in the study). The safety of incremental HD will be tested by comparing the rates of pre-defined safety events in the incremental HD vs. conventional HD groups. The impact of incremental HD on patients' residual renal function will be monitored using serial 24-hour urine collections, bio-impedance testing will be conducted to estimate changes in fluid load, measurements of quality-of-life will be undertaken by using patient KDQOL-SF v1.3 questionnaires. These tests will be repeated at regular intervals. Blood tests for estimation of residual renal function and markers of renal anemia, bone disease and cardiac load will be performed at regular intervals and will be compared between the two groups (incremental HD vs. conventional HD groups). These measurements will help in the evaluation of impact of incremental HD on patients' health and well-being. The completion rates of these tests will provide important information about whether they should be included in a future larger trial of incremental HD. Participants undergoing incremental HD will be invited to take part in semi-structured interviews aimed at exploring patients' experiences of receiving incremental HD and their participation in the study. Data from this study will be used to test if it is feasible to use deaths (or a combination of deaths and cardiovascular events) as the main outcome measure in a future definitive trial on incremental HD. The data should enable a sample-size calculation for a future full-scale trial.

NCT ID: NCT04100421 Completed - Clinical trials for Chronic Kidney Diseases

Exposure Of Bisphenol Analogues In Chronic Kidney Disease and Dialysis Patients

Start date: June 1, 2017
Phase:
Study type: Observational

In this retrospective study, the serum levels of Bisphenol A (BPA) and three BPA analogs, namely, bisphenol B (BPB), bisphenol S (BPS), and bisphenol F (BPF), in patients with CKD, patients on dialysis therapy and healthy control were investigated to find out if BPA and BPA analogs accumulates in patients with chronic kidney disease (CKD), and if hemodialysis filters contribute to bisphenol burden in patients on hemodialysis (HD).

NCT ID: NCT04063423 Completed - Clinical trials for End Stage Renal Disease

Non- Clinical Coagulation Activation During Hemodialysis

NC-Coact
Start date: October 25, 2018
Phase:
Study type: Observational

Every patient included in the study will undergo 1 conventional hemodialysis treatment, ie 1 study visit. During the conventional hemodialysis treatment lasting 4 hours, 2 blood samples will be taken at different time points (5 minutes after dialysis start and 240 minutes after dialysis = at the end of the dialysis session) to evaluate coagulation activation (TAT, PF1+2). Hemodialysis session parameters (arterial and venous pressure, TMP, OCM, BVM and prefilter pressure) will be noted at different time points (T5, T30, T60, T120, T180, T240). After discontinuation of the dialysis session, total cell volume will be measured using the Renatron II system® and the number of open fibers will be determined using micro-CT scanning.

NCT ID: NCT04057313 Completed - Clinical trials for Hemodialysis Complication

Coffee in Hemodialysis and Headache

CoffeeHD
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Coffee is the most consumed drink worldwide, sometimes needed to boost energy and other times to entertain social connectivity. Caffeine is mostly present unbound in the plasma, only 10 to 30% of caffeine binds to plasma proteins. It is distributed freely into the intracellular space, and it has a small distribution volume. Therefore, caffeine can pass through the dialysis membrane during a standard hemodialysis session. In hemodialysis patients, headache occurs in 40 to 75% of patients. Some authors have suggested that one of the reasons of headache during hemodialysis is caffeine withdrawal. This trial aims to find whether coffee intake during hemodialysis reduces the headache episodes. It is a randomized double blind multicenter trial where 160 patients will be randomized to 2 groups: group 1 of 80 patients will be given a cup of coffee each dialysis session for 4 weeks and group 2 will receive decaffeinated coffee each dialysis session for 4 weeks.

NCT ID: NCT03990142 Completed - Clinical trials for Hemodialysis Complication

Study of Abnormalities of the Nervous System in the Occurrence of Intradialytic Arterial Hypotension

SUDHEMO
Start date: June 25, 2019
Phase: N/A
Study type: Interventional

Intradialytic hypotension is a common complication of hemodialysis sessions in patients with chronic renal failure, with an estimated prevalence of 10 to 30%. This hypotensopn is classically defined by a decrease in systolic blood pressure greater than 30 mmHg associated with clinical signs (cramps, abdominal pain, unconsciousness, convulsions). Its repetition is correlated with cardiovascular events, neurological events and excess mortality. Several clinical factors have been proposed to predict the risk of intradialytic hypotension such as age, certain comorbidities (diabetes, ischemic heart disease...), dialysis modalities (hemodialysis), ultrafiltration, conductivity but also alterations of the autonomic nervous system (especially the sympathetic system). In recent years, the study of vegetative functions has been facilitated by the use of SUDOSCAN® (Impeto, Paris, France) which is a simple, non-invasive tool that allows the study of Chlorine conductance directly reflecting the activity of small non-myelinated C fibers that innervate the sweat glands. SUDOSCAN® has shown good sensitivity and specificity in the diagnosis of vegetative damage in diabetic patients and also a good correlation with cardiac autonomic neuropathy. More recently, SUDOSCAN® has shown good sensitivity in the detection of neuropathies small fibers especially in diabetic patients. This sensitivity is comparable to QST-type quantitative tests and the correlation with cardiovascular dysautonomia tests is good. This test, simple and fast realization, does not require the active participation of the patient. There is a good correlation between the results of SUDOSCAN® and the reduction of intra-dermal fiber density at cutaneous biopsy. Hemodialysis patients are at risk of peripheral neurological involvement not only because of an increasing incidence of diabetes (30-40%) but also because of the abnormal production and elimination of certain uremic toxins. Few studies exist on the anomalies of the vegetative system in hemodialysis. A recent publication has suggested a difference in nerve excitability depending on the type of hemodialysis suggesting nerve changes secondary to ionic changes. The identification of patients at risk of intradialytic hypotension during dialysis sessions could be useful for adapting hemodialysis protocols. Patients will be classified into 2 groups according to the occurrence of intradialytic hypotension. Group 1 corresponds to patients with intradialytic hypotension and group 2 corresponds to patients without intradialytic hypotension.