Clinical Trials Logo

Clinical Trial Summary

Online hemodiafiltration confers a reduced mortality risk. However, it is not clear why HDF improved survival. To gain more insight in this issue, the effect of 4 dialysis techniques (differing in dialysate temperature and the absence/presence of convective clearance) on intradialytic hemodynamic stability and cardiac function will be investigated in a prospective cross over trial.


Clinical Trial Description

Despite the use of high permeable dialyzers, which combine diffusive with convective clearance, the clinical outcome of hemodialysis (HD) patients remains poor. In post-dilution online hemodiafiltration (denoted further on as HDF) diffusive clearance is similar to HD, while the amount of convective transport is considerable increased. Recently, 4 randomized controlled trails have been published which compared HD with HDF. Although the results of the individual studies were inconclusive, a recent meta-analysis, using individual patient data of these studies, showed a superior outcome for patients treated with HDF. The largest mortality reduction was obtained in patients receiving the highest convection volume (high-volume HDF [HV-HDF] >23 L/1.73 m2/session): all-cause mortality [22% (95 % confidence interval [CI] 2-38)], cardiovascular disease (CVD) mortality [31% (95 % CI 0-53)]. It is far from clear, however, why (HV)HDF is associated with an improved survival. Both long term and short term effects may be involved. With respect to the latter, the intra-dialytic removal of middle molecular weight (MMW) uremic retention products and a superior bio-incompatibility (BI) profile may play a role. In addition, treatment with HDF may induce less intra-dialytic hypotension (IDH) and less tissue injury. Enhanced removal of the MMW substance FGF23 may reduce the intra-dialytic acute phase reaction (APR), which is regarded a chief element of HD-induced BI. Other key components which may contribute to IDH and are supposed to be alleviated by HDF, include dialysis-induced hypoxia and intra-dialytic extracellular vesicle release. Patho-physiologically, IDH depends both on a decline in the circulating blood volume and an impaired response to hypovolaemia. As a result, venous return, cardiac output and peripheral vascular resistance are impaired. Since IDH is reduced by HD with cool dialysate (C-HD), thermal factors may play an important role. Microcirculatory dysfunction is a prominent feature of HD patients. Since IDH occurs in 20-30% of the sessions, any interference with an already abnormal perfusion may further deteriorate the structure and function of vital organs, such as the brain, gut and heart. HD-associated cardiomyopathy, which is considered a model of repetitive organ ischemia-reperfusion injury, is superimposed on the cardiac changes resulting from the various inflammatory and metabolic derangements of pre-dialysis kidney disease. As measured by imaging techniques and biomarkers, HD induces a fall in cardiac perfusion and elicits tissue injury. While cardiac MRI is considered the reference method for LV quantification, intra-dialytic measurements can only be obtained in stable patients who can be safely transferred to the radiology department. Echocardiography, though, can be performed in all individuals at the bed-side, including hypotension-prone patients. Because of its superiority over standard echocardiography, especially with respect to diastolic (dys)function, speckle tracking echocardiography will be used in the present study. As mentioned, the effect on long term survival is especially prominent when HV-HDF is applied. Theoretically, HV-HDF is also the preferred treatment to circumvent dialysis-induced IDH, and hence, to alleviate the repetitive intra-dialytic tissue damage. Therefore, the following hypotheses will be tested: 1. intra-dialytic hemodynamic stability is better preserved during HV-HDF as compared to standard (S)-HD, C-HD and low volume (LV)-HDF; 2. mainly as a result of a better intra-dialytic hemodynamic stability, the severity of organ injury, especially the heart, is least evident during HV-HDF; 3. the mechanism of a better preserved intra-dialytic hemodynamic stability during HV-HDF depends on its superior thermal balance and/or bio-incompatibility, clearance of MMW substances, or a combination of these items. Worldwide, however, (HV)HDF is only limited available. Since intradialytic hemodynamic instability may contribute substantially to the poor clinical prospects of end-stage-kidney-disease (ESKD) patients, these individuals may benefit from each maneuver that minimizes the number and severity of intradialytic hypotensive episodes. Therefore, the question which of the comparator treatments [(S)-HD, C-HD and LV-HDF] has the best intradialytic hemodynamic stability, appears relevant as well. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03249532
Study type Interventional
Source VU University Medical Center
Contact
Status Completed
Phase N/A
Start date June 1, 2018
Completion date February 15, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT04892745 - Impact of Hemodialysis on Cutaneo-muscular Electrical Impedance
Not yet recruiting NCT04925674 - Study of HEC53856 in Patients With Subjects With End-Stage Renal Disease Receiving Dialysis. Phase 1
Active, not recruiting NCT03183245 - Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis Phase 3
Completed NCT03365635 - Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C Phase 4
Withdrawn NCT02904343 - Evaluation of Domestic Hemodialysis Machine: A Multi-center Clinical Study N/A
Withdrawn NCT01855334 - L-Arginine and Spironolactone Trial in Dialysis-Dependent ESRD Phase 4
Completed NCT01700465 - Estimating and Predicting Hemodynamic Changes During Hemodialysis N/A
Recruiting NCT01195519 - The Assessment of Quality of Life in Patients With Peritoneal Dialysis and Hemodialysis N/A
Completed NCT00737672 - GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis Phase 3
Completed NCT00527774 - Effect of HCV Infection on Insulin Resistance and Malnutrition-inflammation Complex Syndrome in Regular Hemodialysis Patients N/A
Completed NCT00942253 - Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS) Phase 2
Completed NCT00850252 - Use of a Lifeline Graft in the A-V Shunt Model Phase 1/Phase 2
Completed NCT00224081 - DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin) Phase 4
Completed NCT00776750 - Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients Phase 4
Recruiting NCT06351007 - Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Patients (EPAK) N/A
Withdrawn NCT03664141 - Impact of Cannabis Oil on Nutrition in Hemodialysis Patients Study (ICON-HP Study) Phase 3
Completed NCT03909698 - Antibiotic Dosing in Patients on Intermittent Hemodialysis
Recruiting NCT03311321 - Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients N/A
Recruiting NCT06098924 - HD Patients' Depression and Happiness
Recruiting NCT03419923 - Three Anticoagulation Strategies for Hemodialysis in Patients at Risk of Hemorrhage N/A