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临床试验/NCT05341843
NCT05341843已完成2 期

Effectiveness of Sertraline in Alleviating Uremic Pruritis in Hemodialysis Patients

Alexandria University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
1
主要终点
change in uremic pruritis intensity

研究概览

简要总结

This study aims to assess the effect of sertraline on uremic pruritis in patients undergoing regular haemodialysis.

详细描述

The reported prevalence of uremic pruritus in adult hemodialysis patients has varied over the years, and some studies suggest the prevalence may be decreasing with more effective dialysis. One of the largest trials (the Dialysis Outcomes and Practice Patterns Study [DOPPS]) reported that the prevalence of moderate pruritus remained constant at 18 percent until 2015.

A direct role for proinflammatory T cells and cytokines is suggested by studies that showed higher levels of proinflammatory T helper-1 (TH1) cells, C-reactive protein, interleukin-6, and interleukin-2 levels among hemodialysis patients versus those without pruritus. Also, histamine release from mast cells, other pruritogens and xerosis have been all implicated in the pathogenesis of uremic pruritus.

Less convincing associations have also been made to anemia, male sex, increased beta-2 microglobulin levels, serotype human leukocyte antigen (HLA)-B35, and comorbidities including congestive heart failure and neurologic disease. The risk of uremic pruritis appears to be independent of ethnicity, type of dialysis, and underlying renal disease. No single cause underlying uremic pruritus has been identified. Multiple factors have been associated in observational studies, and supportive therapies that are used to treat uremic pruritus have targeted such factors.

High quality evidence on which to base recommendations for the treatment of uremic pruritus is limited. Many pharmacologic treatments have been proposed for uremic pruritis through different clinical trials. However, the results were quite variable and most of these studies were small uncontrolled trials and hence they were flawed.

Several studies have revealed that the selective serotonin reuptake inhibitors (SSRI) could reduce the severity of pruritus. Sertraline hydrochloride is a selective serotonin reuptake inhibitor which established improvement in itching in patients with cholestatic pruritis. This was supported by Browning et al. (2003) whose study showed 86% of subjects who had been given sertraline for another indication improved considerably with pruritus disappearing in 30% of the subjects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

a double blinded study as participants, health care providers as well as the outcome assessor will be unaware about the type of treatment each patient receive.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥1 month of maintenance haemodialysis, 3 times per week for 4 hours.
  • Adult patients with ages between 18-80 years.

排除标准

  • Primary skin diseases (eczema, psoriasis, allergic dermatitis or drug rash).
  • Peripheral neuropathy, thyroid disease, leukemia, lymphoma, liver disease, Systemic lupus erythematosus or pregnancy.
  • Patients who consumed emollients cream, antihistamine, opioid antagonist, immunosuppressants, cholestyramine, corticosteroids or UVB phototherapy 1 month before study.
  • calcium X phosphorus (Ca X P) >55.0 mg/dl, P >5.5 mg/dl, parathyroid hormone (PTH) >450 pg/ml.
  • Selective serotonin reuptake inhibitors intolerance.

研究组 & 干预措施

sertraline

Experimental

they will receive sertraline at the intended dose of 50 mg twice daily for 8 weeks.

干预措施: sertraline (Drug)

placebo

Placebo Comparator

They will receive a placebo in the form of multivitamin tablets similar to the experimental drug with the same regimen, as one tablet /day for 8 weeks

干预措施: placebo (Drug)

结局指标

主要结局

change in uremic pruritis intensity

时间窗: 8 weeks

Assessment of pruritis will be done before and after the course of treatment (8 weeks) through the following scores: I) Visual analogue scale (VAS) II) 5D itch scale

次要结局

未报告次要终点

研究者

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

Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD

Lecturer

Alexandria University

研究点 (1)

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