Clinical Trial: Double Blinded RCT of Types of IVF in Children With DKA

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 se

Detailed Summary:

There have been limited prospective clinical studies in pediatrics patients examining the association of the chloride content of intravenous fluids and outcome in DKA. This prospective randomized controlled trial is being performed to compare the duration of acidosis and hospital length of stay in children with DKA who are admitted to a pediatric intensive care unit and are treated with intravenous fluids containing NS or LR. The primary study hypothesis is that use of LR will be associated with decreased duration of hyperchloremic metabolic acidosis and, therefore, shorter hospitalization than use of NS in the treatment of pediatric DKA.

Primary hypothesis: Children with diabetic ketoacidosis (DKA) who are treated with intravenous fluids containing lactated ringers (LR) will have a shorter duration of hyperchloremic metabolic acidosis after hospital admission than those treated with intravenous fluids containing normal saline (NS).

Secondary hypothesis: The duration of acidosis after hospital admission in children with DKA will be associated with length of stay in the intensive care unit and hospital.

Outcomes

Primary outcome

The primary study outcome will be duration of metabolic acidosis. Resolution of metabolic acidosis will be defined in three ways:

  1. Serum ketone level <1mmol/L;
  2. Venous pH > 7.3;
  3. Serum bicarbonate level > 18mmol/L.

Secondary outcomes Secondary outcomes will include length of stay in the pediatric intensive care unit and length of stay in the
Sponsor: State University of New York at Buffalo

Current Primary Outcome: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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


Original Secondary Outcome: Same as current

Information By: State University of New York at Buffalo

Dates:
Date Received: February 23, 2017
Date Started: April 1, 2017
Date Completion: June 30, 2019
Last Updated: March 6, 2017
Last Verified: February 2017