Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 6:57 PM
Study NCT ID:
NCT06890195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-21
First Post:
2025-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dialysate Cooling Versus Sodium Profiling in Management of Intradialytic Hypotension Among Chronic Hemodialysis Patients
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Effect of Dialysate Cooling Versus Sodium Profiling in Management of Intradialytic Hypotension Among Chronic Hemodialysis Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
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:
Chronic kidney disease (CKD) is a worldwide public health issue. Dialysis patients have a tenfold greater relative risk of cardiovascular death than the general population.
Dialysate cooling prevents intradialytic hypotension (IDH). This is achieved by inducing vasoconstriction and activating the sympathetic nervous and therefore improving hemodynamic stability .
Intradialytic hypotension (IDH) is a common complication of HD. There is no consensus on the definition of IDH, but (IDH) is commonly defined as a drop in blood pressure during dialysis procedure and/ or hypotensive symptoms such as dizziness, weakness, nausea, cramps, blurred vision, and fatigue .
The pathophysiology of IDH is diverse. It could be the result of an inadequate cardiovascular response to the reduction in blood volume that occurs when the ultrafiltration volume is large . One process may involve an imbalance between a reduced effective circulating volume and the compensatory plasma refilling mechanism, wherein fluid from the interstitial and intracellular space is translocated into the intravascular compartment .
Cold dialysis reduces HD-induced brain damage by protecting the cerebral vascular beds from harmful perfusion . In the heart, long- term cold dialysis improved resting ejection fraction and reduced left ventricular mass and end-diastolic volumes while preserving aortic distensibility, decreasing the risk for future cardiovascular events
. Risk factors associated with IDH include old age, female gender, Hispanic ethnicity, long dialysis vintage, high intradialytic weight gain, high dialysis dose, anemia, diabetes, low pre-dialysis BP, high osmolarity, and high body mass index .
It can be applied universally and reduce the need for nursing involvement . Further, no additional cost is needed to conduct fixed reduction of dialysate temperature. While there are various methods of reducing dialysate temperature, optimal temperature or methods of temperature reduction to prevent IDH remain uncertain
To study the effect of dialysate cooling (0.5- 1 C lower than pre- dialysis core body temperature) Vs traditional sodium profiling on:
1. Reduction the episodes of IDH .
2. Net dry weight achievements.
3. Post dialysis fatigue.
Dialysate cooling prevents intradialytic hypotension (IDH). This is achieved by inducing vasoconstriction and activating the sympathetic nervous and therefore improving hemodynamic stability .
Intradialytic hypotension (IDH) is a common complication of HD. There is no consensus on the definition of IDH, but (IDH) is commonly defined as a drop in blood pressure during dialysis procedure and/ or hypotensive symptoms such as dizziness, weakness, nausea, cramps, blurred vision, and fatigue .
The pathophysiology of IDH is diverse. It could be the result of an inadequate cardiovascular response to the reduction in blood volume that occurs when the ultrafiltration volume is large . One process may involve an imbalance between a reduced effective circulating volume and the compensatory plasma refilling mechanism, wherein fluid from the interstitial and intracellular space is translocated into the intravascular compartment .
Cold dialysis reduces HD-induced brain damage by protecting the cerebral vascular beds from harmful perfusion . In the heart, long- term cold dialysis improved resting ejection fraction and reduced left ventricular mass and end-diastolic volumes while preserving aortic distensibility, decreasing the risk for future cardiovascular events
. Risk factors associated with IDH include old age, female gender, Hispanic ethnicity, long dialysis vintage, high intradialytic weight gain, high dialysis dose, anemia, diabetes, low pre-dialysis BP, high osmolarity, and high body mass index .
It can be applied universally and reduce the need for nursing involvement . Further, no additional cost is needed to conduct fixed reduction of dialysate temperature. While there are various methods of reducing dialysate temperature, optimal temperature or methods of temperature reduction to prevent IDH remain uncertain
To study the effect of dialysate cooling (0.5- 1 C lower than pre- dialysis core body temperature) Vs traditional sodium profiling on:
1. Reduction the episodes of IDH .
2. Net dry weight achievements.
3. Post dialysis fatigue.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: