Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04755491
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2021-02-11
Brief Title:
Chloride Transfer During Continuous Renal Replacement Therapy in the Intensive Care Unit a Prospective Observational Cohort Study
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Chloride Transfer During Continuous Renal Replacement Therapy in the Intensive Care Unit a Prospective Observational Cohort Study
Status:
COMPLETED
Status Verified Date:
2022-09
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:
CLODICUS
Brief Summary:
Acute kidney injury AKI is a frequently encountered complication in the intensive care unit ICU affecting on average 25 to 35 of patients It is associated with an increased mortality proportional to AKI severity RRT induces important shifts of water and electrolytes Thus significant amount of chloride might unintentionally be transferred to patients
Chloride is the main anion of the organism It is involved in the regulation of numerous physiological processes Thus significant and rapid modification of chloride amount contained in the organism as might be induced by renal replacement therapy may be responsible for important and potentially deleterious consequences to critically ill patients
Studies have shown that the administration of high amounts of chloride rich solutions such as sodium chloride NaCl 09 was associated with the development of hyperchloremic acidosis in a dose-dependent manner This hyperchloremic acidosis could also be theoretically associated with deleterious physiological effects However the true clinical consequences of administration of high amounts of chloride rich solutions remains unclear Their effect on mortality remains a matter of debate the results of studies being very conflicting in that respect Nevertheless hyperchloremia itself andor the rise of chloremia in the intensive care unit seems to be associated with increased mortality Moreover the impact of those chloride rich solutions on the development of acute kidney injury is also a subject of controversy data from the literature being here again very conflicting
A recent study already showed that continuous RRT CRRT techniques induce a significant transfer of sodium to patients benefiting from those techniques In that study the amount of sodium transferred depended mainly on the difference between patients natremia and sodium concentration in dialysate andor replacement fluid usually higher than patients natremia used
By analogy it is likely that an occult transfer of chloride also happens during RRT given the high chloride concentration of dialysate fluids in continuous veno-venous dialysis CVVD and replacement fluids in continuous veno-venous hemofiltration CVVH or when these 2 modalities are combined continuous veno-venous hemodiafiltration CVVHDF Finally the investigators suspect although it remains undemonstrated so far that the RRT technique convective vs diffusive may influence this transfer to an unknown extent Nevertheless this transfer and its potential determinants have never been studied yet
If chloride overload and its potential clinical consequences induced by the administration of solutions such as NaCl 09 is being extensively studied no study has ever focused on chloride transfer that may result from the use of renal replacement therapy However as mentioned above it is very likely that such a chloride transfer to patients happens and that its magnitude depends on different parameters such as RRT modality RRT fluids characteristics or patients chloremia at the start of RRT
The investigators conduct the present study to describe and compare the intensity of chloride transfer during the first 24 hours of renal replacement therapy by continuous veno-venous hemofiltration CVVH continuous veno-venous hemodialysis CVVDor continuous veno-venous hemodiafiltration CVVHDF and to determine if that transfer is more important with one or the other of those two techniques in ICU patients affected with severe AKI requiring RRT Secondary aims are to describe and compare the effects of chloride transfer under 3 RRT modalities CVVD CVVH and CVVHDF on patients outcome organ failures electrolyte and acid-base balance fluid balance and hemodynamics Finally the investigators aim to develop a pharmacokinetic compartment model of chloride transfer during different modalities of RRT
Chloride is the main anion of the organism It is involved in the regulation of numerous physiological processes Thus significant and rapid modification of chloride amount contained in the organism as might be induced by renal replacement therapy may be responsible for important and potentially deleterious consequences to critically ill patients
Studies have shown that the administration of high amounts of chloride rich solutions such as sodium chloride NaCl 09 was associated with the development of hyperchloremic acidosis in a dose-dependent manner This hyperchloremic acidosis could also be theoretically associated with deleterious physiological effects However the true clinical consequences of administration of high amounts of chloride rich solutions remains unclear Their effect on mortality remains a matter of debate the results of studies being very conflicting in that respect Nevertheless hyperchloremia itself andor the rise of chloremia in the intensive care unit seems to be associated with increased mortality Moreover the impact of those chloride rich solutions on the development of acute kidney injury is also a subject of controversy data from the literature being here again very conflicting
A recent study already showed that continuous RRT CRRT techniques induce a significant transfer of sodium to patients benefiting from those techniques In that study the amount of sodium transferred depended mainly on the difference between patients natremia and sodium concentration in dialysate andor replacement fluid usually higher than patients natremia used
By analogy it is likely that an occult transfer of chloride also happens during RRT given the high chloride concentration of dialysate fluids in continuous veno-venous dialysis CVVD and replacement fluids in continuous veno-venous hemofiltration CVVH or when these 2 modalities are combined continuous veno-venous hemodiafiltration CVVHDF Finally the investigators suspect although it remains undemonstrated so far that the RRT technique convective vs diffusive may influence this transfer to an unknown extent Nevertheless this transfer and its potential determinants have never been studied yet
If chloride overload and its potential clinical consequences induced by the administration of solutions such as NaCl 09 is being extensively studied no study has ever focused on chloride transfer that may result from the use of renal replacement therapy However as mentioned above it is very likely that such a chloride transfer to patients happens and that its magnitude depends on different parameters such as RRT modality RRT fluids characteristics or patients chloremia at the start of RRT
The investigators conduct the present study to describe and compare the intensity of chloride transfer during the first 24 hours of renal replacement therapy by continuous veno-venous hemofiltration CVVH continuous veno-venous hemodialysis CVVDor continuous veno-venous hemodiafiltration CVVHDF and to determine if that transfer is more important with one or the other of those two techniques in ICU patients affected with severe AKI requiring RRT Secondary aims are to describe and compare the effects of chloride transfer under 3 RRT modalities CVVD CVVH and CVVHDF on patients outcome organ failures electrolyte and acid-base balance fluid balance and hemodynamics Finally the investigators aim to develop a pharmacokinetic compartment model of chloride transfer during different modalities of RRT
Detailed Description:
None
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