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临床试验/NCT05905692
NCT05905692进行中(未招募)3 期

Evaluation of the Impact of L- Carnitine in Intradialytic Hypotension in Pediatric Patients on Regular Hemodialysis

Ain Shams University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年5月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
进行中(未招募)
入组人数
50
试验地点
1
主要终点
The number of events of intradialytic hypotension

研究概览

简要总结

Intradialytic hypotension (IDH) is defined as less than the 5th percentile of SBP measurements and is associated with clinical symptoms, such as abdominal pain, nausea, vomiting, muscle cramps, restlessness, light-headedness, syncope, and anxiety. In adults There is no consensus definition of IDH, however, according to the Kidney Disease Outcomes Quality Initiative and European Best Practice Guidelines, IDH is defined as a decline in systolic blood pressure ≥20 mmHg or a decrease in a mean arterial pressure by 10 mmHg and associated with clinical events like abdominal pain, nausea, vomiting, muscle cramps, dizziness, fatigue, and restlessness.

IDH occurs in response to the reduction in blood volume (BV) during ultrafiltration (UF) and subsequent poor compensatory mechanisms due to abnormal cardiac function (left ventricular dysfunction, chamber remodeling, congenital heart diseases, and arrhythmias) or autonomic or baroreceptor failure. To maintain volume status, the body shifts fluid from the interstitial space to the intravascular space and increases heart rate, contractility, and vascular tone.

Plasma refilling, another essential factor in maintaining euvolemia, depends on oncotic, osmotic, and hydraulic gradients across vascular beds. If UF rates surpass plasma refilling rates, intravascular volume falls and hypotension results. Hematocrit levels, tissue hydration and arterial vasoconstriction all promote plasma refilling rates. Alterations in these factors during dialysis decrease the plasma refilling rate, resulting in hypotension.

Aim of The Work:

The aim of this study is to assess and evaluate the efficacy and safety of L Carnitine in the prevention of intradialytic hypotension in pediatric patients on regular hemodialysis.

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
Double (Participant, Care Provider)

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 6-18 years
  • Patients on hemodialysis for 3 months or longer
  • Patients on hemodialysis frequency 3 times weekly (with the same dialysate concentration and temperature)
  • Patients who had two or more episodes of intradialytic hypotension during dialysis (less than the 5th percentile of SBP measurements and is associated with clinical symptoms) in the last 3 months.

排除标准

  • Patients with life expectancy < 3 months
  • Patients with known hypersensitivity to L carnitine
  • Patients received L carnitine in the previous 6 months

研究组 & 干预措施

L carnitine group

Experimental

patients will take L carnitine (20 mg/kg/day) 3 times per week (on the same days of the dialysis session, 30 minutes before the session)

干预措施: L Carnitine (Drug)

Placebo group

Placebo Comparator

patients will take placebo 3 times per week (on the same days of the dialysis session, 30 minutes before the session)

干预措施: L Carnitine (Drug)

结局指标

主要结局

The number of events of intradialytic hypotension

时间窗: 3 months (end of the study)

how many times intradialytic hypotension occurs

次要结局

  • development of any adverse effects or side effect in the L carnitine group.(up to 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Radwa Maher Abd El Kader El Borolossy

Lecturer of clinical pharmacy

Ain Shams University

研究点 (1)

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