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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intradialytic Hypotension
• Intervention / Treatment: Procedure: dialysate cooling; Procedure: standard dialysate temperature

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; dialysate cooling group: patients will be subjected to individualized cool dialysate (dialysate temperature 0.5 °C lower than core body temperature)	Procedure: dialysate cooling; patients will be subjected to individualized cool dialysate (dialysate temperature 0.5 °C lower than core body temperature)
Placebo Comparator: Group B; sodium profiling group: patients will be subjected to standard dialysate temperature (dialysate temperature of 37 °C).	Procedure: standard dialysate temperature; patients will be subjected to standard dialysate temperature (dialysate temperature of 37 °C).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number in IDH episodes	compare the total number in IDH episodes and Frequency of hypotensive symptoms between two group	6 week

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension; Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: cooling VS sodium profilingIDH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No