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临床试验/NCT07423559
NCT07423559已完成不适用

Comparison of Intensive Care Unit Stay and Relapse Among Diabetic Ketoacidosis Patients Maintained Basal Bolus Insulin Administration in Combination With Continuous Intravenous Insulin Infusion VS Non Maintaining Basal Insulin Patients

Tanta University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年11月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Resolution of diabetic ketoacidosis

研究概览

简要总结

This study aimed to assess intensive care unit stay and relapse among patients of Diabetic ketoacidosis (type 1 diabetes mellitus) maintained basal bolus insulin and patients non maintaining along with intervenors insulin infusion.

详细描述

Diabetic ketoacidosis is one of the common, potentially serious, and avoidable acute complications of diabetes mellitus. Diabetic ketoacidosis is caused by a decrease in effective circulating insulin associated with elevations in counter-regulatory hormones . This potentially life-threatening complication of type 1.

diabetes mellitus is frequently mismanaged, leading to morbidity and increased length of stay. Advances in near-patient testing technology have improved patient care, by facilitating rapid diagnosis and closer monitoring of treatment response.

Diabetic ketoacidosis most often occurs in people with type 1 diabetes, but can also occur in patients with poorly controlled type 2 diabetes under stressful conditions .

Management of Diabetic ketoacidosis requires reversing metabolic derangements by correcting volume depletion and electrolyte imbalances and administering insulin to correct acidosis while concurrently treating the precipitating illness .

Diabetic ketoacidosis is traditionally managed using intravenous regular insulin infusion in intensive care unit /high dependency unit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 21y or more
  • who are known to have type 1 diabetes on known basal bolus insulin regimen - presented with diabetic ketoacidosis.

排除标准

  • Patients with type 2 diabetes mellitus.
  • If hemodynamically unstable patients.
  • Patients with other metabolic problems (hepatic coma, renal failure, disturbed conscious level .

研究组 & 干预措施

Group I

Experimental

Patients treated with insulin infusion without basal insulin.

干预措施: insulin infusion without basal insulin (Drug)

Group II

Experimental

Patients treated with insulin infusion with basal insulin.

干预措施: insulin infusion with basal insulin (Drug)

Group III

Experimental

Patients treated with insulin infusion with basal insulin and bolus.

干预措施: Insulin infusion with basal insulin and bolus (Drug)

结局指标

主要结局

Resolution of diabetic ketoacidosis

时间窗: 4 days

Criteria of resolution of Diabetic Ketoacidosis The anion gap (AG) \<12 mEq/L. Venous pH \>7.3. Serum bicarbonate ≥15 mEq/L

次要结局

  • Random blood sugar assessment(every 2 hours till 4 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwa Hashem Mahrous Saad

Resident

Tanta University

研究点 (1)

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