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

NCT06890195 | Not Yet Recruiting DMC

• 1 other identifier: cooling VS sodium profilingIDH
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

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. 1.Reduction the episodes of IDH .
2. 2.Net dry weight achievements.
3. 3.Post dialysis fatigue.

Conditions

Intradialytic Hypotension

Outcome Measures

Primary Outcomes (1)

• number in IDH episodes

  compare the total number in IDH episodes and Frequency of hypotensive symptoms between two group

  6 week

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Procedure: dialysate cooling

Group B

PLACEBO COMPARATOR

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

Procedure: standard dialysate temperature

Interventions

dialysate cooling PROCEDURE

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

Group A

standard dialysate temperature PROCEDURE

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

Group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 18-70 years old.
• Maintained on HD for not less than 6 months
• Documented episodes of IDH

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rsidant doctor

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 21, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-03