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Double Blinded Randomized Control Trial of Types of IVF in Children With DKA

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ClinicalTrials.gov Identifier: NCT03066440
Recruitment Status : Suspended (Shortage of potassium acetate for study intravenous fluids)
First Posted : February 28, 2017
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
State University of New York at Buffalo

Brief Summary:

Objectives: Intravenous (IV) fluid administration is a fundamental component of diabetic ketoacidosis (DKA) treatment. Normal saline (NS), the most common IV fluid used in DKA management, contains more chloride than human blood. Excessive amounts of chloride have been shown to cause a detrimental metabolic acidosis. Other IV fluids have more physiologic chloride levels, such as lactated ringers (LR). This study will compare the rates of hyperchloremic metabolic acidosis in children treated with NS to those treated with LR to determine the effect on overall length of acidosis and length of stay in the hospital or intensive care unit.

Design: Single-center, double blinded, randomized controlled trial.

Subjects: Children aged 0 to 18 years who present with diabetic ketoacidosis and require pediatric intensive care unit admission. Patients with evidence of shock, multi-organ failure or clinically significant cerebral edema will be excluded. The projected study population will be 104 patients, 52 in each arm.

Interventions: Patients will be enrolled within 1 hour of presentation to the emergency room or pediatric intensive care unit if transferred directly from another facility. They will be randomized to receive intravenous fluids containing 0.9% saline or lactated ringers. All patients will be treated using the institutional DKA protocol with the content of the intravenous fluids being the only difference in treatment between arms. Study intervention lasts until the end of the acute management of DKA.

Planned measurements and study outcomes: The primary study outcome will be duration of metabolic acidosis. Resolution of metabolic acidosis will be defined in three ways: 1. Normalization of the ketosis; 2. Normalization of the serum pH; 3. Normalization of the serum bicarbonate level. Secondary outcomes will include length of stay in the pediatric intensive care unit and length of stay in the hospital. All outcomes will be correlated with the overall chloride load given via intravenous fluids during DKA management. Regression modelling will control for any baseline differences between the groups in regards to severity of DKA, and if newly diagnosed or poorly controlled diabetes mellitus.


Condition or disease Intervention/treatment Phase
Diabetic Ketoacidosis Drug: Normal saline Drug: Lactated Ringers Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-center randomized double-blinded control trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The intravenous fluids administered will all have generic labeling making the study arm assignment unknown to all providers, study personnel and participants. Only the pharmacist filling the orders will known arm assignment.
Primary Purpose: Treatment
Official Title: A Single-center Randomized Double Blinded Control Trial of Intravenous Fluid Content in Children With Diabetic Ketoacidosis Admitted to the Pediatric Intensive Care Unit
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Normal Saline
Intervention: intravenous solutions containing only normal saline as the primary base during the entire treatment of diabetic ketoacidosis.
Drug: Normal saline
All intravenous fluids used in the treatment of pediatric diabetic ketoacidosis will be based in normal saline for participants in the interventional arm instead of normal saline (as given to participants in the control arm).
Other Name: 0.9 saline

Experimental: Lactated Ringers
Intervention: intravenous solutions containing only lactated ringers as the primary base during the entire treatment of diabetic ketoacidosis.
Drug: Lactated Ringers
All intravenous fluids used in the treatment of pediatric diabetic ketoacidosis will be based in lactated ringer's solution for participants in the interventional arm instead of normal saline (as given to participants in the control arm).
Other Name: Hartmann's Solution




Primary Outcome Measures :
  1. Length of acidosis [ Time Frame: 28 days ]
    The time from admission to the emergency room or pediatric intensive care unit to resolution of acidosis (defined as normal pH, serum bicarbonate level >15 and serum ketone level <1)


Secondary Outcome Measures :
  1. Length of stay in the pediatric intensive care unit [ Time Frame: 28 days ]
    Time from admission to the emergency room or pediatric intensive care unit and transfer from the pediatric intensive care unit to the general pediatric ward

  2. Length of stay in the hospital [ Time Frame: 28 days ]
    Time from admission to the emergency room or pediatric intensive care unit and transfer from the pediatric intensive care unit to discharge home



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 0 and 18 years
  2. Diagnosis of DKA:

    1. Venous pH less than 7.25
    2. Ketonuria as confirmed on urine point-of-care testing or urinalysis
    3. Hyperglycemia (Serum glucose > 200 mg/dl)
    4. Serum bicarbonate <15 mmol/L
  3. PICU admission

Exclusion Criteria:

  1. Age > 18 Years
  2. Physician discretion
  3. Septic or hypovolemic shock
  4. Signs of life-threatening cerebral edema or multi-organ failure upon presentation to the emergency room or pediatric intensive care unit
  5. Enrollment time more than 1 hr since arrival to emergency room or PICU
  6. Pregnancy

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): NCT03066440


Locations
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United States, New York
John R. Oishei Children's Hospital
Buffalo, New York, United States, 14203
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
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Principal Investigator: Amanda B Hassinger, MD, MS SUNY University at Buffalo

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Responsible Party: State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT03066440     History of Changes
Other Study ID Numbers: 00001394
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by State University of New York at Buffalo:
diabetic ketoacidosis
fluid management
hyperchloremia
Additional relevant MeSH terms:
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Ketosis
Acidosis
Diabetic Ketoacidosis
Acid-Base Imbalance
Metabolic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Diabetes Complications
Endocrine System Diseases
Pharmaceutical Solutions