Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Time to Anion Gap Closure
研究概览
简要总结
Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management
详细描述
The transition from IV Insulin Infusion (IVII) to Subcutaneous Long-acting insulin injections in Diabetic Ketoacidosis (DKA) management frequently results in rebound hyperglycemia, particularly if there are high insulin requirements that can adversely affect the DKA recovery, increase Length Of Stay (LOS), morbidity, and mortality. Investigators propose a prospective, open-label, intervention, non-randomized, controlled study to test the hypothesis that an insulin glargine dose of 0.4 Units/kg early administered (within four hours) of IVII initiation in DKA management in adult would be effective and safe in shortening the time to anion gap closure comparing to the standard practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Meet DKA definition (BG ≥ 250 mg/dl, Anion Gap > 12 mEq/L, and positive Ketones in serum or urine)
- •Having the capacity to sign Informed consent
排除标准
- •IV insulin infusion was initiated for more than 4 hours.
- •Persistent hypotension (SBP<80 mmHg despite receiving 1000cc normal saline).
- •Require Vasopressor
- •Acute Coronary Syndrome
- •End-stage renal disease
- •Unwilling to consent to participate in the trial
- •Currently under police custody
- •Transferred from another hospital
- •Require emergent surgery
研究组 & 干预措施
Early Glargine
All consecutive adult patients getting admitted to Medical ICU and meet the inclusion criteria and accepted to receive insulin glargine early as per the protocol. They will receive insulin glargine 0.4 unit/kg within 4 hours from initiating the IV Insulin Infusion, as per the Cleveland Clinic DKA protocol.
干预措施: Early Glargine (Drug)
Early Glargine
All consecutive adult patients getting admitted to Medical ICU and meet the inclusion criteria and accepted to receive insulin glargine early as per the protocol. They will receive insulin glargine 0.4 unit/kg within 4 hours from initiating the IV Insulin Infusion, as per the Cleveland Clinic DKA protocol.
干预措施: IV insulin infusion (Other)
Early Glargine
All consecutive adult patients getting admitted to Medical ICU and meet the inclusion criteria and accepted to receive insulin glargine early as per the protocol. They will receive insulin glargine 0.4 unit/kg within 4 hours from initiating the IV Insulin Infusion, as per the Cleveland Clinic DKA protocol.
干预措施: IV fluid and electrolytes replacement (Other)
Standard practice (Late Glargine)
Retrospective, prespecified and matched sample of consecutive adults who admitted to the same Medical ICU with a diagnosis of DKA in the period between January 1st 2019 till the Institutional Review Board (IRB) approval date and didn't receive basal insulin before Anion Gap closure.
干预措施: Late Glargine (Drug)
Standard practice (Late Glargine)
Retrospective, prespecified and matched sample of consecutive adults who admitted to the same Medical ICU with a diagnosis of DKA in the period between January 1st 2019 till the Institutional Review Board (IRB) approval date and didn't receive basal insulin before Anion Gap closure.
干预措施: IV insulin infusion (Other)
Standard practice (Late Glargine)
Retrospective, prespecified and matched sample of consecutive adults who admitted to the same Medical ICU with a diagnosis of DKA in the period between January 1st 2019 till the Institutional Review Board (IRB) approval date and didn't receive basal insulin before Anion Gap closure.
干预措施: IV fluid and electrolytes replacement (Other)
结局指标
主要结局
Time to Anion Gap Closure
时间窗: Participants monitored from hospital admission to discharge, an average of 5 days
Measured in hours from starting insulin infusion till anion gap ≤ 12 milliequivalent/Liter (mEq/L)
次要结局
- Hospital Length of Stay(Participants monitored from hospital admission to discharge, an average of 5 days)
- ICU Length of Stay(Participants monitored from hospital admission to discharge, an average of 5 days)
- Incidence of Transitional Failure(up to 24 hours after IVII discontinuation)
- Total IV Insulin Infusion Dose(Participants monitored from hospital admission to discharge, an average of 5 days)
- Incidence of Hyperglycemia(up to 24 hours after initial Insulin Glargine dose)
- Incidence of Hypoglycemia(up to 24 hours after initial Insulin Glargine dose)
研究者
Mohammed Al-Jaghbeer
Clinical Assistant professor and Principal Investigator
The Cleveland Clinic