CTRI/2025/12/099219尚未招募不适用
Balanced crystalloids versus normal saline efficacy in adults with diabetic ketoacidosis in the emergency department: prospective single blind randomized controlled superiority trial.
Tarun Rana1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年12月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time of resolution of DKA from starting of treatment. Its based on lab criteria, pH7.35 bicarbonate 18 meq/lit
研究概览
简要总结
This trail is comparing the efficacy of fluids which is ringers lactate vs normal saline in resolution of DKA. As limited studies are present in the Emergency setting hence this trail is being done to collect more data that will be helpful in standardizing the fluid management of dka in emergency settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patient more than or equal to 18 years of age has clinical criteria satisfying for DKA.
- •blood glucose more than 200 Anion gap more than 10mmol per lit Bicarbonate level less than 18 Presence of beta hydroxy butyrate or ketone in blood or urine.
排除标准
- •Patient received treatment from outside facility in form of iv fluids more than 1 litre.
- •Refered TO AIIMS for further care only.
- •Had euglycemic DKA.
结局指标
主要结局
Time of resolution of DKA from starting of treatment. Its based on lab criteria, pH7.35 bicarbonate 18 meq/lit
时间窗: To find the time of DKA resolution, patient will be assessed every 2 hourly with venous blood gas.
次要结局
- To compare time to insulin pump discontinuation (hours)(To compare electrolyte abnormalities including hyperkalemia, hypokalemia & hyperchloridemia.)
研究者
Tarun Rana
Aiims Rishikesh
研究点 (1)
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