Effect of Dialysate Cooling Versus Sodium Profiling in Management of Intradialytic Hypotension Among Chronic Hemodialysis Patients

NCT ID: NCT06890195

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-08-01

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.

Conditions

Intradialytic Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

dialysate cooling group: patients will be subjected to individualized cool dialysate (dialysate temperature 0.5 °C lower than core body temperature)

Group Type: ACTIVE_COMPARATOR

dialysate cooling

Intervention Type: PROCEDURE

patients will be subjected to individualized cool dialysate (dialysate temperature 0.5 °C lower than core body temperature)

Group B

sodium profiling group: patients will be subjected to standard dialysate temperature (dialysate temperature of 37 °C).

Group Type: PLACEBO_COMPARATOR

standard dialysate temperature

Intervention Type: PROCEDURE

patients will be subjected to standard dialysate temperature (dialysate temperature of 37 °C).

Interventions

dialysate cooling

patients will be subjected to individualized cool dialysate (dialysate temperature 0.5 °C lower than core body temperature)

Intervention Type: PROCEDURE

standard dialysate temperature

patients will be subjected to standard dialysate temperature (dialysate temperature of 37 °C).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• • Patients age 18-70 years old.

• Maintained on HD for not less than 6 months
• Documented episodes of IDH

Exclusion Criteria

• • Severly anemic patients (Hb<7 g/dl)

• Patients taking more than 3 antihypertensive (on days other than dialysis day).
• Patients with documented IHD.
• Patients on midodraine therapy prior dialysis session.
• patient refusal, incompliance or ineffective dialysis.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Samir Abbas

Rsidant doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

cooling VS sodium profilingIDH

Identifier Type: -

Identifier Source: org_study_id