Effect of Dialysate Cooling Versus Sodium Profiling in Management of Intradialytic Hypotension Among Chronic Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 106
- 主要终点
- number in IDH episodes
研究概览
简要总结
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:
- Reduction the episodes of IDH .
- Net dry weight achievements.
- Post dialysis fatigue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients age 18-70 years old.
- •Maintained on HD for not less than 6 months
- •Documented episodes of IDH
排除标准
- •• 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.
研究组 & 干预措施
Group A
dialysate cooling group: patients will be subjected to individualized cool dialysate (dialysate temperature 0.5 °C lower than core body temperature)
干预措施: dialysate cooling (Procedure)
Group B
sodium profiling group: patients will be subjected to standard dialysate temperature (dialysate temperature of 37 °C).
干预措施: standard dialysate temperature (Procedure)
结局指标
主要结局
number in IDH episodes
时间窗: 6 week
compare the total number in IDH episodes and Frequency of hypotensive symptoms between two group
次要结局
未报告次要终点
研究者
Mostafa Samir Abbas
Rsidant doctor
Assiut University