临床试验/CTRI/2025/02/080980

CTRI/2025/02/080980

招募中

3 期

Plasma-Lyte-A versus Normal Saline for intravenous fluid therapy in children: A Randomized Controlled Trial

Jawaharlal Nehru Medical College1 个研究点分布在 1 个国家目标入组 438 人开始时间: 2025年3月3日最近更新: 2025年2月20日

概览

阶段: 3 期
状态: 招募中
发起方: Jawaharlal Nehru Medical College
入组人数: 438
试验地点: 1
主要终点: Increase in serum chloride by at least 5 mmol/L

概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

概览

简要总结

This randomized controlled trial is designed to compare, in hospital setting, two isotonic fluids, i.e. Plasma-Lyte A and normal saline for intravenous fluid therapy in children. The primary outcome measure of the study is change in serum chloride level at 48 hours from baseline. Secondary outcome measures include new onset AKI, length of PICU stay, length of hospital stay and PICU-free survival.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 0.50 Year(s) 至 14.00 Year(s)（—）
性别: All

入选标准

•Admitted to PICU or emergency due to medical conditions.
•Need for intravenous fluid administration
•Serum sodium more than 130 mmol/L (measured on admission or no longer than 48 h before randomization).

排除标准

•Pre-existing conditions like cardiac conditions and chronic kidney disease.
•Disease-specific IVF protocols.
•Traumatic brain injury or at risk of cerebral edema, Burns, Post-liver transplant, post-renal transplant, Diabetic ketoacidosis, Oncology patients needing hyperhydration.
•Blood sugar less than 60 mg/dl at the time of start of intervention and during 48 hours of intervention.

结局指标

主要结局

Increase in serum chloride by at least 5 mmol/L

时间窗: At baseline and at the end of 48 hours from the beginning of the infusion of intervention/comparator agents

次要结局

1. New-onset acute kidney injury (AKI).(2. Length of PICU stay)

研究者

发起方

Jawaharlal Nehru Medical College

申办方类型

Government medical college

责任方

Principal Investigator

主要研究者

Kamran Afzal

Jawaharlal Nehru Medical College, AMU

研究点 (1)

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