Clinical Trials Logo
  1. Home
  2. Diabetic Ketoacidosis
  3. NCT00920725
  4. Details
NCT00920725 Clinical Trial

Subcutaneous Aspart Insulin to Treat Diabetic Ketoacidosis (DKA) and Beta-Hydroxybutyrate Testing in DKA

Diabetic Ketoacidosis Clinical Trial

— DKA  

Official title:
Subcutaneous Aspart Insulin and Point of Care Beta Hydroxybutyrate Testing: A New Paradigm for the Management of Diabetic Ketoacidosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00920725
Other study ID # 05012103
Secondary ID
Status Completed
Phase N/A
First received June 12, 2009
Last updated August 14, 2012
Start date January 2005
Est. completion date December 2007

Study information
Verified date August 2012
Source Rush University Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether insulin administered by a subcutaneous injection is effective in the treatment of a diabetic crisis and to determine if beta-hydroxybutyrate is useful to monitor during treatment of a diabetic crisis.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date December 2007
Est. primary completion date July 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria: age 18 or older

- venous pH < 7.3 or arterial < 7.35

- at least 2 of the following 3:

1. serum HCO3 < 18/anion gap > 16

2. serum glucose > 300 mg/dl

3. serum acetone positive

Exclusion Criteria:

- pregnant

- less than age 18

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Insulin (Aspart Insulin [Novolog], Regular Insulin)
Aspart Insulin 0.2units/sq q 2 hours Regular Insulin 0.1units/kg/hr intravenous Aspart Insulin 0.1 units/kg/hr intravenous

Locations
Country Name City State
United States Rush University Medical Center Chicago Illinois

Sponsors (2)
Lead Sponsor Collaborator
Rush University Medical Center Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hours to resolution of ketoacidosis as defined as beta-hydroxybutyrate <0.6 q 2 hours No
Primary Hours to achieve blood glucose less than 200mg/dl q 1 hour No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Completed NCT03660189 - Two Bag System for Diabetic Ketoacidosis N/A
Terminated NCT03066440 - Double Blinded Randomized Control Trial of Types of IVF in Children With DKA Phase 4
Completed NCT04940897 - Use of Blood Ketone Meters to Improve Ambulance Hyperglycaemia Care N/A
Completed NCT02930044 - Early Subcutaneous Insulin Glargine Plus Standard of Care for Treatment of Diabetic Ketoacidosis N/A
Completed NCT04926740 - Intravenous Fluids in Adults With Diabetic Ketoacidosis in the Emergency Department N/A
Terminated NCT04567225 - Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management Phase 4
Completed NCT04017221 - Safety of Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors Among Patients With Type 2 Diabetes
Recruiting NCT03717896 - Thiamine as Adjunctive Therapy for Diabetic Ketoacidosis Phase 2
Terminated NCT02548494 - Early Administration of Long-acting Insulin Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes N/A
Completed NCT02006342 - Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis N/A
Completed NCT01753921 - Evaluation of a Non-invasive Brain Compliance Measurement Device
Completed NCT01365793 - Randomized Control Trial of Fluid Therapy for Pediatric Diabetic Ketoacidosis Phase 3
Completed NCT00426413 - Ketosis Prone Diabetes in African-Americans N/A
Not yet recruiting NCT05867797 - Risk Factors and Outcomes of Acute Kidney Injury in Patients With Diabetic Ketoacidosis at Sohag University Hospital.
Terminated NCT04234867 - Study to Explore the Effect of Dapagliflozin and Stress in Adolescent and Adult Subjects With Type 1 Diabetes (T1D) Phase 1
Not yet recruiting NCT05752279 - Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis Phase 3
Completed NCT04825639 - Identifying Risk Factors for Developing AKI in Sepsis
Recruiting NCT05155917 - Concurrent Subcutaneous Basal Insulin and Intravenous Insulin Pump in Hyperglycemic Crisis Patients Under Critical Care Phase 2
Recruiting NCT05383404 - Clinical and Laboratory Parameters Associated With Different Degrees of Dehydration Among Children With Diabetic Ketoacidosis