【ChiCTR2500113572】Comparison of Effectiveness of Oral Furosemide-Metolazone Versus Oral Furosemide-Spironolactone Combination Therapy in Management of Refractory Edema in Children with Nephrotic Syndrome.

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基本信息

登记号

ChiCTR2500113572

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2025-12-01

临床申请受理号

靶点

适应症

Nephrotic Syndrome

试验通俗题目

Comparison of Effectiveness of Oral Furosemide-Metolazone Versus Oral Furosemide-Spironolactone Combination Therapy in Management of Refractory Edema in Children with Nephrotic Syndrome.

试验专业题目

Comparison of Effectiveness of Oral Furosemide-Metolazone Versus Oral Furosemide-Spironolactone Combination Therapy in Management of Refractory Edema in Children with Nephrotic Syndrome.

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

54000

联系人通讯地址

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临床试验信息

试验目的

The aim of the study is to compare the effectiveness of oral furosemide-metolazone versus oral furosemide-spironolactone combination therapy in the management of refractory edema in children with nephrotic syndrome.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

Patients will be divided in two groups and recruited in the study through convenient sampling technique and then will be randomly assigned to each group according to consort guidelines 2010 by principle investigator. Written informed consent will be taken and will be allocated either to Group 1 or Group 2 by simple random sampling through sealed opaque envelope. Individuals in Group 1 will be given Oral Furosemide-Metolazone combination of diuretics. Individuals in Group 2 will be given Oral Furosemide-Spironolactone combination of diuretics.

盲法

Study medications should be packaged identically and labeled with participant ID only. Pharmacy (unblinded) prepares and dispenses; investigators, outcome assessors and participants remain blinded.

试验项目经费来源

Hospital

试验范围

目标入组人数

实际入组人数

第一例入组时间

2026-01-01

试验终止时间

2027-01-02

是否属于一致性

入选标准

1. Children diagnosed with nephrotic syndrome with refractory edema or severe anasarca and not achieving weight loss or diuresis after 2 days of treatment with oral furosemide therapy. 2. Age > 1 year and less than 15 years.；

排除标准

1. Patients taking albumin therapy. 2. Nephrotic syndrome patient caretakers who will refuse to give consent 3. The patients who will achieve weight loss or diuresis within 2 days of treatment with oral furosemide therapy. Children < 1 year and >15 years with nephrotic syndrome admitted in our department fulfilling inclusion criterion.；

研究者信息

研究负责人姓名

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试验机构

The Children's Hospital Lahore.

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

54000

联系人通讯地址