Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394843
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-15
Brief Title:
Fluid Currents During Hemodialysis
Sponsor:
Joachim Zdolsek
Organization:
University Hospital Linkoeping
Study Overview
Official Title:
Mobilization of Fluid and Fluid Currents During Hemodialysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
During dialysis three objectives are achieved 1 Blood is cleansed from waste products 2 Excess water is removed 3 Electrolytes are regulated These processes occur simultaneously but vary from patient to patient depending on their specific needs Some patients still produce urine but of poor quality Others have no residual urine production at all and require removal of fluid from both blood and tissues Hypotension may occur during dialysis related to intravascular hypovolemia and inadequate fluid reinfusion which is common during ultrafiltration exceeding 400 mlh The amount of fluid removed is influenced by fluid recruitment from tissues This mainly occurs in two different ways osmotic recruitment across capillary membranes from the perivascular space or via lymphatic reflow The proportions are not fully understood When fluid is recruited from the perivascular space the influx of albumin and immunoglobulins is unlikely However these should accompany lymph to the blood if lymphatic flow is increased The content of albumin and immunoglobulins differs between lymph and plasma Thus the proportions of fluid recruitment from tissues should be calculable using mass balance calculations based on ultrafiltrate colloid osmotic pressure hemoglobin albumin and immunoglobulin concentrations The rate and proportions of fluid reinfusion into the bloodstream are not fully understood Therefore in this study the aim is to monitor fluid reinfusion and its proportions of lymphosmotic recruitment into the bloodstream
Detailed Description:
In Sweden approximately 3200 patients undergo hemodialysis annually In some cases it is solely about blood purification but for many patients removal of excess fluid accumulated since the last dialysis treatment is also necessary The amount of fluid removalultrafiltration prescribed by the physician during dialysis primarily depends on the amount of residual urine the patient produces but also on the patients fluid intake between dialysis treatments The most common complication of hemodialysis is hypotension during treatment occurring in about 10 of treatment sessions according to previous studies These hypotensive episodes lead to temporary hypoperfusion and repeated episodes can cause permanent organ damage The main cause of these hypotensive episodes is the reduction in circulating volume during ultrafiltration ie fluid removal The excess fluid that the patient accumulates between treatments is mainly located outside the bloodstream Therefore in connection with fluid removal during hemodialysis there is compensatory fluid recruitment to the circulation increasing the circulating volume and preventing hypotension How this occurs and from which fluid compartment fluid is recruited is not yet mapped out To increase understanding of hemodialysis and optimize treatment while minimizing the risk of hypotension it is interesting to understand how fluid recruitment occurs and from which fluid compartments recruitment occurs Using fluid kinetic calculations it has been possible to measure whether fluid is recruited perivascularly or from the lymphatic system during albumin infusion depending on the concentrations of proteins such as IgG and IgM as their concentrations differ By measuring the concentrations of these proteins in blood samples over time it has been possible to calculate from which fluid compartment fluid has been recruited
Purpose and Objective
The aim is to study
How much fluid is drawn from the interstitial space during dialysis depending on whether fluid removal is needed or not
The size and rate of fluid reinfusion during ongoing dialysis
The composition of the recruited fluid from the interstitium ie the proportion consisting of lymphlymph reflow and the proportion recruited across capillary membranesvenulae from the pericapillary space
Hypotheses The null hypothesis is that no detectable difference in fluid flows or source of fluid recruitment is found between patients where a large volume is dialyzed and those patients who do not have significant fluid removal during dialysis
The alternative hypothesis is that a clinical relevant difference in fluid flows from the interstitium and the pathway for fluid recruitment to the bloodstream is detected
Outcome Measures
Primary outcome variables are
Recruitment of fluid from the interstitium calculated from fluid removal and hemoglobin changes Proportion of recruited fluid via lymph or via capillaryvenulae walls based on fluid recruitment and changes in plasma albumin and immunoglobulins G and M
Secondary outcome variables are
Weight blood pressure impact and changes in bioimpedance variables
Study Design
Open-label prospective clinical observational study where patients are divided into two groups One group with an intact urine production and dialysis is performed solely to cleanse the blood and second group with little or no urine production which requires significant fluid removal in addition to blood purification
Purpose and Objective
The aim is to study
How much fluid is drawn from the interstitial space during dialysis depending on whether fluid removal is needed or not
The size and rate of fluid reinfusion during ongoing dialysis
The composition of the recruited fluid from the interstitium ie the proportion consisting of lymphlymph reflow and the proportion recruited across capillary membranesvenulae from the pericapillary space
Hypotheses The null hypothesis is that no detectable difference in fluid flows or source of fluid recruitment is found between patients where a large volume is dialyzed and those patients who do not have significant fluid removal during dialysis
The alternative hypothesis is that a clinical relevant difference in fluid flows from the interstitium and the pathway for fluid recruitment to the bloodstream is detected
Outcome Measures
Primary outcome variables are
Recruitment of fluid from the interstitium calculated from fluid removal and hemoglobin changes Proportion of recruited fluid via lymph or via capillaryvenulae walls based on fluid recruitment and changes in plasma albumin and immunoglobulins G and M
Secondary outcome variables are
Weight blood pressure impact and changes in bioimpedance variables
Study Design
Open-label prospective clinical observational study where patients are divided into two groups One group with an intact urine production and dialysis is performed solely to cleanse the blood and second group with little or no urine production which requires significant fluid removal in addition to blood purification
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