To compare the effect of Normal Saline vs Ringer Lactate on resolution time of biochemical parameters in patients presenting to Department of Trauma and Emergency with Diabetic Ketoacidosis : A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Time taken for resolution of biochemical parameters in groups receiving normal saline vs ringer lactate.
研究概览
简要总结
Diabetic ketoacidosis (DKA) is an acute, life threatening complication of diabetes requiring replacement of fluid losses with IV fluids, correction of hyperglycemia with appropriate administration of insulin, correction of electrolyte losses, detection of precipitating causes and maintenance insulin to prevent recurrence.
In adult subjects with DKA, the overall mortality is <1%; however, a mortality of > 5 % has been reported in the elderly and in patients with concomitant life threatening illnesses. Current DKA treatment guidelines recommend normal saline (NS-0.9% sodium chloride) for resuscitation and treatment of DKA. Normal saline administration causes hyperchloremic metabolic acidosis, which is associated increased incidences of AKI.
This study aims to find which IV fluid administration leads to faster resolution of diabetic ketoacidosis among normal saline and ringer lactate; as its primary objective. As its secondary objectives this study aims to to find changes in metabolic and clinical parameters over period of time and incidences of hyperkalemia episodes, during treatment using either fluid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Meeting laboratory diagnostic criteria of diabetic ketoacidosis (As per ADA) Blood glucose greater than or equal to 250 mg/dl.
- •pH less than 7.
- •Bicarbonate less than18 mEq/L.
- •Blood Ketones greater than or equal to 3.0 mmol/L.
排除标准
- •Patients with cardiogenic shock Patients with CKD Patients with CLD Pregnant patients.
结局指标
主要结局
Time taken for resolution of biochemical parameters in groups receiving normal saline vs ringer lactate.
时间窗: Time taken until resolution of Diabetes Ketoacidosis
次要结局
- Change in chloride, bicarbonate, pH levels over time(Time taken for resolution of Diabetic ketoacidosis)
- Comparison of effect on clinical parameters in both study groups(Time taken for resolution of Diabetic ketoacidosis)
- Incidence of hyper/hypokalemic events during study interval.(Time taken for resolution of Diabetic ketoacidosis)
研究者
Ashok Choudhary
ALL INDIA INSTITUTE OF MEDICAL SCIENCES