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

NCT03066440 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 00001394
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Ketoacidosis

Keywords

diabetic ketoacidosis; fluid management; hyperchloremia

Outcome Measures

Primary Outcomes (1)

• Length of Acidosis

  Hours to pH\>7.25 and normal anion gap and serum bicarbonate over 15

  28 days

Secondary Outcomes (2)

• Length of Stay in the Pediatric Intensive Care Unit

  28 days

• Length of Stay in the Hospital

  28 days

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

Intervention: intravenous solutions containing only normal saline as the primary base during the entire treatment of diabetic ketoacidosis.

Drug: Normal saline

Lactated Ringers

EXPERIMENTAL

Intervention: intravenous solutions containing only lactated ringers as the primary base during the entire treatment of diabetic ketoacidosis.

Drug: Lactated Ringers

Interventions

Normal saline DRUG

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).

Also known as: 0.9 saline

Normal Saline

Lactated Ringers DRUG

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).

Also known as: Hartmann's Solution

Lactated Ringers

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 0 and 18 years
• Diagnosis of DKA:
• Venous pH less than 7.25
• Ketonuria as confirmed on urine point-of-care testing or urinalysis
• Hyperglycemia (Serum glucose \> 200 mg/dl)
• Serum bicarbonate \<15 mmol/L
• PICU admission

You may not qualify if:

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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

John R. Oishei Children's Hospital

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Diabetic Ketoacidosis

Interventions

Saline Solution; Sodium Chloride; Ringer's Lactate

Condition Hierarchy (Ancestors)

Ketosis; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Amanda B. Hassinger, Medical Director of the UBMD Pediatrics Sleep Center
• Organization: UBMD Pediatrics

albrooks@buffalo.edu

716-323-0158

Study Officials

• Amanda B Hassinger, MD, MS

  SUNY University at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-center randomized double-blinded control trial

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: February 28, 2017
• Study Start: September 1, 2018
• Primary Completion: March 18, 2024
• Study Completion: March 18, 2024
• Last Updated: August 6, 2024
• Results First Posted: August 6, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)