Ignite Creation Date:
2024-05-06 @ 10:24 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03249532
Status:
COMPLETED
Last Update Posted:
2021-11-30
First Post:
2017-05-23
Brief Title:
Effect of Dialysis Techniques on Blood Pressure and Cardiac Function During Dialysis
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Effect of High-volume Online hemodiafiLtration on Intra-diaLytic hemodynAmic iNsTability and Cardiac Function in Chronic Hemodialysis Patients the HOLLANT Study
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOLLANT
Brief 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 absencepresence of convective clearance on intradialytic hemodynamic stability and cardiac function will be investigated in a prospective cross over trial
Detailed 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 L173 m2session 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 HVHDF 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 dysfunction 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 andor bio-incompatibility clearance of MMW substances or a combination of these items
Worldwide however HVHDF 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
It is far from clear however why HVHDF 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 dysfunction 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 andor bio-incompatibility clearance of MMW substances or a combination of these items
Worldwide however HVHDF 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None