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Two Bag System for Hydration in Diabetes

This study has been terminated.
(Because Monitoring Committee found significant (and clinical meaningful) difference between groups regarding main outcome, Ethics Committee terminated the study)
Sponsor:
Information provided by (Responsible Party):
Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier:
NCT01631929
First received: June 25, 2012
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

This is a randomized controlled trial comparing the time needed to get the conditions to space hourly controls to controls every 4 hours, using the one bag system versus the two bags system, in the initial treatment of children with diabetic ketoacidosis. After fast infusion of isotonic saline solution (20 ml/kg) to prevent shock, the administration of maintenance fluids and insulin therapy is indicated. Hourly plasmatic levels of glucose controls could determine changes in glucose IV administration. On using the classic one bag system each change determine a bag change. Using the two bag system allows to deliver the patient the appropriate glucose infusion in less time.


Condition Intervention
Diabetes
Ketoacidosis
Other: One bag
Other: Two bags

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Two Bag System vs. One Bag System for Hydration Patients With Diabetic Ketoacidosis

Resource links provided by NLM:


Further study details as provided by Hospital General de Niños Pedro de Elizalde:

Primary Outcome Measures:
  • Time to achieve patient stabilization [ Time Frame: Participants will be followed for the duration of ketoacidosis, an expected average of 8 hours ] [ Designated as safety issue: No ]

    Time needed to achieve patient stabilization defined by:

    • Plasmatic glucose < 250 mg/dl
    • Blood pH > 7.3
    • Plasmatic bicarbonate > 15 mmol/L
    • Negative ketonuria
    • Negative glycosuria


Enrollment: 12
Study Start Date: August 2012
Study Completion Date: July 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: One bag
IV infusion of fluids, electrolytes and dextrose using one bag
Other: One bag
Infusion of dextrose and electrolytes using one bag
Experimental: Two bags
Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.
Other: Two bags
Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.

Detailed Description:

The treatment of children with diabetic ketoacidosis includes fast infusion of isotonic saline solution to prevent shock (20 ml/kg), and then the administration of maintenance fluids and insulin therapy according to hourly plasmatic glucose levels controls. Finally, after patients stabilization, controls becomes less frequents (each 4 hours).

During the stabilization period infusion of glucose is calculated hourly according to plasmatic glucose levels. These modifications in IV infusion can be very frequent, sometimes by the hour, requiring preparation of a new solution for hydration (in a new bag).

This procedure takes time, during which the patient continues receiving the previous IV infusion until the changes are effectively made. Therefore, usually changes are not strictly hourly, interfering with the adjustment of the organism to the above mentioned changes.

The 2 bag system consists in using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line. Using this system allows that changes needed in the administration of fluids and/or dextrose, may be easily and instantly managed by delivering different amounts from each bag to achieve the desired infusion rate without having to replace the bag.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between 1 to 18 years old
  • Diabetic ketoacidosis(plasmatic glucose > 250mg/dl, pH < 7.3, bicarbonate < 15mmol/L, ketonuria and glycosuria)

Exclusion Criteria:

  • Patients who already received insulin in the Emergency Department.
  • Patients who, because of their clinical condition, require admission to intensive care unit.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631929

Locations
Argentina
Hospital General de NIños Pedro de Elizalde
Buenos Aires, Argentina, C1270AAN
Sponsors and Collaborators
Hospital General de Niños Pedro de Elizalde
Investigators
Principal Investigator: Juan P Ferrira, MD Hospital General de Niños Pedro de Elizalde
  More Information

Publications:
Responsible Party: Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier: NCT01631929     History of Changes
Other Study ID Numbers: 65-HGNPE-2012
Study First Received: June 25, 2012
Last Updated: August 29, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Hospital General de Niños Pedro de Elizalde:
Diabetes
Ketoacidosis
Children

Additional relevant MeSH terms:
Diabetes Mellitus
Ketosis
Acid-Base Imbalance
Acidosis
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014