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Trial record 14 of 34 for:    DKA | "Diabetic Ketoacidosis"

Early Administration of Long-acting Insulin Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT02548494
Recruitment Status : Recruiting
First Posted : September 14, 2015
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
Rita Shridharani, Chattanooga-Hamilton County Hospital Authority

Brief Summary:

The management goals of diabetic ketoacidosis (DKA) in the pediatric type 1 diabetes (T1DM) population are fluid and electrolyte repletion, insulin administration, and correction of acidosis in order to stabilize the patient. Traditionally, a rapid-acting insulin IV infusion is begun immediately and continued until the acidosis is corrected and hyperglycemia normalized. Once the acidosis is corrected, patients are able to be transitioned to a subcutaneous insulin regimen.

The role that a subcutaneous long-acting insulin such as glargine has in the acute treatment of DKA has not been extensively studied. While giving glargine during the treatment of DKA is becoming more common place, few studies have examined the potential risks and benefits of its use. This study will investigate the effects of early administration of glargine during DKA in patients with newly diagnosed TIDM.

The design of this study is a prospective, double-blind study of children ages 2-21 who are admitted to the hospital in DKA with a diagnosis of T1DM. The control group will receive all traditional methods of treatment for DKA, including a placebo subcutaneous injection. The study group will receive the same treatment, but will be supplemented with a subcutaneous glargine injection.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Diabetic Ketoacidosis Drug: Glargine Drug: IV insulin Other: Electrolyte Correction Other: Correction of Fluid Loss Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Early Administration of Long-acting Insulin Glargine for the Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes: A Randomized Double Blind Trial
Study Start Date : November 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Placebo Comparator: Control Group
The control group will receive all traditional methods of treatment for DKA including iv insulin, correction of fluid loss, and electrolyte correction, including a placebo subcutaneous injection.
Drug: IV insulin
The intravenous infusion of insulin at a weight-based fixed rate until ketosis has subsided.

Other: Electrolyte Correction
If the potassium level is greater than 6 mEq/L, do not administer potassium supplement. If the potassium level is 4.5-6 mEq/L, administer 10 mEq/h of potassium chloride. If the potassium level is 3-4.5 mEq/L, administer 20 mEq/h of potassium chloride.

Other: Correction of Fluid Loss

Initial correction of fluid loss is either by isotonic sodium chloride solution or by lactated Ringer solution. The recommended schedule for restoring fluids is as follows:

  • Administer 1-3 L during the first hour.
  • Administer 1 L during the second hour.
  • Administer 1 L during the following 2 hours
  • Administer 1 L every 4 hours, depending on the degree of dehydration and central venous pressure readings

Experimental: Treatment Group
The study group will receive the same treatment including iv insulin, correction of fluid loss, and electrolyte correction, but will be supplemented with a subcutaneous glargine injection.
Drug: Glargine
The control group will receive all traditional methods of treatment for DKA, including a placebo subcutaneous injection. The study group will receive the same treatment, but will be supplemented with a subcutaneous glargine injection.
Other Name: Lantus

Drug: IV insulin
The intravenous infusion of insulin at a weight-based fixed rate until ketosis has subsided.

Other: Electrolyte Correction
If the potassium level is greater than 6 mEq/L, do not administer potassium supplement. If the potassium level is 4.5-6 mEq/L, administer 10 mEq/h of potassium chloride. If the potassium level is 3-4.5 mEq/L, administer 20 mEq/h of potassium chloride.

Other: Correction of Fluid Loss

Initial correction of fluid loss is either by isotonic sodium chloride solution or by lactated Ringer solution. The recommended schedule for restoring fluids is as follows:

  • Administer 1-3 L during the first hour.
  • Administer 1 L during the second hour.
  • Administer 1 L during the following 2 hours
  • Administer 1 L every 4 hours, depending on the degree of dehydration and central venous pressure readings




Primary Outcome Measures :
  1. Blood glucose [ Time Frame: Within 3 hrs of arrival ]

Secondary Outcome Measures :
  1. Blood glucose [ Time Frame: 4 hours after intervention initiation ]
    checking for changes in levels after intervention initiation

  2. blood pH [ Time Frame: within 3 hours of arrival ]
  3. blood pH [ Time Frame: 4 hours after intervention initiation ]
    checking for changes in levels after intervention initiation

  4. blood bicarbonate level [ Time Frame: Within 3 hrs of arrival ]
  5. blood bicarbonate level [ Time Frame: 4 hours after intervention initiation ]
    checking for changes in levels after intervention initiation

  6. Urinalysis for levels of ketones & glucosuria [ Time Frame: Within 3 hrs of arrival ]
  7. Urinalysis for levels of ketones & glucosuria [ Time Frame: 4 hours after intervention initiation ]
    checking for changes in levels after intervention initiation


Other Outcome Measures:
  1. Length of PICU Stay [ Time Frame: 1-2 days ]
  2. Length of Hospital Stay [ Time Frame: 1-5 days ]
  3. Hypoglycemic events [ Time Frame: length of hospital stay, an expected average of 3 days ]
    Hypoglycemia is defined as blood glucose less than 70 mg/dL.



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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • T1DM
  • Hyperglycemia >200 mg/dl
  • Bicarbonate ≤ 15 mmol/L
  • pH < 7.3
  • Ketonemia
  • Ketonuria
  • Glucosuria
  • Admission to PICU (Pediatric Intensive Care Unit)
  • Ages 1-21 years

Exclusion Criteria:

  • Patients who received glargine within the last 24 hours
  • Patients with sepsis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548494


Contacts
Contact: Rita Shridharani, MD 423-778-5521 rita.shridharani@erlanger.org

Locations
United States, Tennessee
Children's @ Erlanger Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Rita K Shridharani, MD    423-778-7000    Rita.Shridharani@Erlanger.org   
Sub-Investigator: Gregory Talbott, MD         
Sub-Investigator: Alissa Guarneri, MD         
Sub-Investigator: Amy Gerwin, PharmD         
Sponsors and Collaborators
Chattanooga-Hamilton County Hospital Authority
Investigators
Principal Investigator: Rita Shridharani, MD UTCOMC/ Children's at Erlanger

Publications:
Responsible Party: Rita Shridharani, Dr. Shridharani, Chattanooga-Hamilton County Hospital Authority
ClinicalTrials.gov Identifier: NCT02548494     History of Changes
Other Study ID Numbers: 15-Lantus
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Diabetic Ketoacidosis
Diabetes Mellitus
Diabetes Mellitus, Type 1
Ketosis
Acidosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Acid-Base Imbalance
Diabetes Complications
Insulin, Globin Zinc
Insulin
Insulin Glargine
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs