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NCT06890195
Effect of Dialysate Cooling Versus Sodium Profiling in Management of Intradialytic Hypotension Among Chronic Hemodialysis Patients
NA trial testing dialysate cooling in Intradialytic Hypotension in 106 participants. Not yet recruiting.
1 April 2026
Quick facts
| Lead sponsor | Assiut University |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 106 |
| Start date | 1 April 2025 |
| Primary completion | 1 April 2026 |
| Estimated completion | 1 August 2026 |
Drugs / interventions tested
- dialysate cooling
- standard dialysate temperature
Conditions studied
- Intradialytic Hypotension — all drugs for Intradialytic Hypotension →
Sponsor
Assiut University
Who can join
Adults 18 to 70, any sex, with Intradialytic Hypotension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06890195
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Related trials
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Currently open trials in the same condition.
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- NCT07033273 — Inferior Vena Cava Collapsibility Index and Intradialytic Hypotension · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06890195 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assiut University
- Last refreshed: 21 March 2025
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