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临床试验/CTRI/2024/10/074986
CTRI/2024/10/074986已完成不适用

A Randomized Control trial to Compare Balanced Salt Solution with Normal Saline for fluid resuscitation in pateints with Diabetic Ketoacidosis reporting to Emergency Department.

Dr Kriti Gupta1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年10月23日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
92
试验地点
1
主要终点
Time of DKA resolution

研究概览

简要总结

Along with insulin therapy, intravenous fluid administration to expand intravascular, interstitial, and intracellular volume is a key component of the acute management of diabetic ketoacidosis (DKA).1-3 Saline (0.9% sodium chloride, also called normal saline) is the most commonly used fluid for this purpose and the primary fluid recommended in current DKA clinical practice guidelines.1-3 The chloride concentration in saline (154 mmol/L) is higher than that in human plasma (94-111 mmol/L), which can cause hyperchloremic metabolic acidosis, especially when administered in large volumes.4-7 Although the clinical outcomes of saline infusion remain incompletely understood, accumulating evidence suggests that saline may increase the risk of kidney injury and impair recovery from severe illness, possibly because of the induction of metabolic acidosis.8-13. Balanced salt solution(BSS), including Ringer lactate and Plasma-Lyte A contain

chloride concentrations similar to those in human plasma and do not induce metabolic acidosis.4-7 Therefore, treatment of DKA with balanced salt solution rather than saline may lead to faster resolution of DKA.14-17

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Double

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Fitting the ADA criteria for DKA.

排除标准

  • Pt with hypervolemia or conditions where giving liberal fluid is contraindicated.
  • Pregnant women.

结局指标

主要结局

Time of DKA resolution

时间窗: Assessment and assignment to DKA as per ADA guidelines at arrival of the patient to ED. Considering it as baseline values. | Hourly RBS, 2nd Hourly VBG for pH, anion gap and bicarbonate values, till resolution of DKA. | Resolution will be considered in correspondence to ADA guidelines for DKA.

Resolution will be considered in correspondence to ADA guidelines for DKA.

时间窗: Assessment and assignment to DKA as per ADA guidelines at arrival of the patient to ED. Considering it as baseline values. | Hourly RBS, 2nd Hourly VBG for pH, anion gap and bicarbonate values, till resolution of DKA. | Resolution will be considered in correspondence to ADA guidelines for DKA.

次要结局

  • Time of insulin infusion(New electrolytes changes)

研究者

发起方
Dr Kriti Gupta
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Kriti Gupta

AIIMS raipur

研究点 (1)

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