Ringer's lactate for Diabetic Ketoacidosis (BRISK-ED Trial)

N/A

Waitlist Available

Led By Justin W Yan, MD, MSc

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether Ringer's Lactate, a type of IV fluid, can help adults with diabetic ketoacidosis (DKA) recover faster than the commonly used normal saline. Ringer's Lactate is thought to be more balanced and less likely to increase blood acidity. If successful, this could lead to shorter hospital stays and better outcomes for patients. Ringer's Lactate has been studied as an alternative to normal saline for various conditions, including diabetic ketoacidosis, due to its balanced electrolyte composition and lower risk of causing acidosis.

Eligible Conditions

Diabetic Ketoacidosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient recruitment rate (feasibility outcome)

Time to DKA resolution (efficacy outcome)

Secondary study objectives

Hospital length of stay

Hyper- or hypo-kalemia post-emergency department

In-hospital acute kidney injury (Stage 2 or greater) post-emergency department

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ringer's lactateExperimental Treatment1 Intervention

The intervention is administration of IV Ringer's lactate. Rate of study fluid will be at the treating physician's (both ED and inpatient, if consulted for admission) discretion. Apart from fluid administered, there will be no other changes to the patient's clinical care, and patients will receive standard DKA treatment which may include insulin, electrolyte replacement, and/or supportive management. Pharmacy-prepared kits of 8 x 1L bags of study fluid (in Self et al., a maximum of 7090mL was given8) will be kept in a secure space within the ED. Once packaged, IV bags are useable for 30 days before expiration. If a kit is opened but not used completely, individual 1L bags may be returned to the pharmacy to save on costs.

Group II: Normal salineActive Control1 Intervention

The comparator is administration of IV normal saline. Rate of study fluid will be at the treating physician's (both ED and inpatient, if consulted for admission) discretion. Apart from fluid administered, there will be no other changes to the patient's clinical care, and patients will receive standard DKA treatment which may include insulin, electrolyte replacement, and/or supportive management. Pharmacy-prepared kits of 8 x 1L bags of study fluid (in Self et al., a maximum of 7090mL was given8) will be kept in a secure space within the ED. Once packaged, IV bags are useable for 30 days before expiration. If a kit is opened but not used completely, individual 1L bags may be returned to the pharmacy to save on costs.

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