Two Bag System for Diabetic Ketoacidosis

NCT ID: NCT03660189

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-17
• Study Completion Date: 2023-06-15

Brief Summary

This is a study investigating the best way to treat diabetic ketoacidosis (DKA) with intravenous (IV) fluids in the hospital. The purpose of this study is to determine whether the "two bag" system of administering IV fluids for the treatment of adults with DKA leads to a shorter time requiring intravenous insulin (a shorter time to anion gap closure), when compared to usual care the traditional "one bag" system of IV fluids. Participants will be assigned randomly to either the usual care group or the "two bag" system group. Based on studies performed in the past, the investigators predict that patients treated with the two bag system of IV fluids for DKA will have a significantly shorter time requiring treatment with intravenous insulin when compared to the traditional one bag system.

Detailed Description

The two bag system has been studied in the pediatric population and is used frequently in pediatric intensive care units. It involves two bags of identical fluids with electrolytes, except one bag has 0% dextrose and the other has 10% dextrose. The two fluid bags run simultaneously into a single IV. The rates of the two fluid bags are adjusted according to the patient's blood sugar. Since the hyperglycemia in DKA typically corrects before the ketosis, this provides a more efficient method of titrating the dextrose concentration based on the patient's needs, while continuing to infuse the insulin at a constant rate to prevent further ketogenesis. The benefits of the two bag system from the pediatric literature include: decreased response time to IV fluid changes, decreased time to correction of bicarbonate and ketones, and decreased total IV fluid volume administered. There was one retrospective study of the two bag system in adults, which showed decreased time to anion gap closure and decreased hypoglycemic events. To this date, there are no prospective randomized trials to evaluate the efficacy of the two bag system in adults.

Patients admitted with DKA in the critical care pavilion will be randomized to either the "two bag system" or "usual care" group.

Patients in both groups will be treated for DKA with IV fluid resuscitation for dehydration and an insulin infusion according to usual care, recommended at 0.1 U/kg/hr.

The two bag system of IV fluids will be ordered as delineated below:

If blood sugar is > 300, run D10 solution at 0 ml/hr and saline solution at 200 ml/hr.

If blood sugar is 250-299, run D10 solution at 50 ml/hr and saline solution at 150 ml/hr.

If blood sugar is 200-249, run D10 solution at 100 ml/hr and saline solution at 100 ml/hr.

If blood sugar is 150-199, run D10 solution at 150 ml/hr and saline solution at 50 ml/hr.

If blood sugar is < 150, run D10 solution at 200 ml/hr and saline solution at 0 ml/hr.

The control group will be usual care of DKA based on the American Diabetes Association Guidelines using a "one bag system."

In both groups, blood sugars will be checked every hour while on the insulin drip. A basic metabolic panel will be checked every 4 hours to monitor the anion gap. Once the anion gap is closed on two occasions and the subject is able to tolerate an enteral diet, the patient will be transitioned to subcutaneous insulin and insulin drip will be discontinued.

Conditions

Diabetic Ketoacidosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Usual care

Usual care with a one bag system of IV fluids, as recommended in the American Diabetes Association consensus statement guidelines from 2009.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Two bag system

A two bag system of IV fluids will be used during insulin infusion administration.

Group Type: EXPERIMENTAL

Two bag system

Intervention Type: OTHER

The two IV fluid bags have identical fluids and electrolytes, except one has 10% dextrose and the other has no dextrose. The two fluid bags run simultaneously and their rates are adjusted according to the patient's blood sugar.

Interventions

Two bag system

The two IV fluid bags have identical fluids and electrolytes, except one has 10% dextrose and the other has no dextrose. The two fluid bags run simultaneously and their rates are adjusted according to the patient's blood sugar.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of diabetic ketoacidosis defined as:

1. Blood sugar greater than 250 mg/dl

2. Venous pH less than 7.25

3. Bicarbonate less than 18

4. Evidence of ketone formation with either positive urine ketones or elevated beta-hydroxybutyrate > 3

5. Anion gap greater than 10 +/ - 2 (or higher than expected anion gap corrected for albumin)

2. 18-85 years of age

Exclusion Criteria

1. Pregnancy

2. Hyperglycemic hyperosmolar state

3. Ketosis from other etiology such as starvation or alcoholic ketosis

4. Acute exacerbation of congestive heart failure

5. Acute coronary syndrome or non-ST elevation MI

6. Pulmonary edema from other cause such as decompensated liver failure or acute renal failure

7. Renal failure requiring renal replacement therapy (hemodialysis)

8. Septic shock

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MetroHealth Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Vidya Krishnan

Professor, Case Western Reserve University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vidya Krishnan, MD

Role: PRINCIPAL_INVESTIGATOR

MetroHealth Medical Center

Locations

MetroHealth Medical Center

Cleveland, Ohio, United States

Countries

United States

References

Kitabchi AE, Umpierrez GE, Murphy MB, Kreisberg RA. Hyperglycemic crises in adult patients with diabetes: a consensus statement from the American Diabetes Association. Diabetes Care. 2006 Dec;29(12):2739-48. doi: 10.2337/dc06-9916. No abstract available.

Reference Type: BACKGROUND

PMID: 17130218 (View on PubMed)

Grimberg A, Cerri RW, Satin-Smith M, Cohen P. The "two bag system" for variable intravenous dextrose and fluid administration: benefits in diabetic ketoacidosis management. J Pediatr. 1999 Mar;134(3):376-8. doi: 10.1016/s0022-3476(99)70469-5.

Reference Type: BACKGROUND

PMID: 10064682 (View on PubMed)

So TY, Grunewalder E. Evaluation of the two-bag system for fluid management in pediatric patients with diabetic ketoacidosis. J Pediatr Pharmacol Ther. 2009 Apr;14(2):100-5. doi: 10.5863/1551-6776-14.2.100.

Reference Type: BACKGROUND

PMID: 23055897 (View on PubMed)

Munir I, Fargo R, Garrison R, Yang A, Cheng A, Kang I, Motabar A, Xu K, Loo LK, Kim DI. Comparison of a 'two-bag system' versus conventional treatment protocol ('one-bag system') in the management of diabetic ketoacidosis. BMJ Open Diabetes Res Care. 2017 Aug 11;5(1):e000395. doi: 10.1136/bmjdrc-2017-000395. eCollection 2017.

Reference Type: BACKGROUND

PMID: 28878933 (View on PubMed)

Poirier MP, Greer D, Satin-Smith M. A prospective study of the "two-bag system'' in diabetic ketoacidosis management. Clin Pediatr (Phila). 2004 Nov-Dec;43(9):809-13. doi: 10.1177/000992280404300904.

Reference Type: BACKGROUND

PMID: 15583776 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB18-00025

Identifier Type: -

Identifier Source: org_study_id