Two Bag System for Diabetic Ketoacidosis

NCT03660189 | Terminated Results DMC

• 1 other identifier: IRB18-00025
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Ketoacidosis

Keywords

intravenous fluids; adults; two bag system

Outcome Measures

Primary Outcomes (1)

• Time to Anion Gap Closure in Hours

  Anion gap (Na - Cl - HCO3) is within normal range when corrected for the albumin (time to anion gap closure will be defined as the time to the first occurrence of a normal anion gap).

  while in DKA

Secondary Outcomes (11)

• Number of Participants Experiencing Hypoglycemic Episodes

  while in DKA

• Number of Participants Experiencing Hypoxic Episodes

  while in DKA

• Pulmonary Edema

  while in DKA

• Chest Pain With EKG Changes

  while in DKA

• Hyponatremia Events

  while in DKA

Study Arms (2)

Usual care

NO INTERVENTION

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

Two bag system

EXPERIMENTAL

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

Other: Two bag system

Interventions

Two bag system 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.

Two bag system

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of diabetic ketoacidosis defined as:
• Blood sugar greater than 250 mg/dl
• Venous pH less than 7.25
• Bicarbonate less than 18
• Evidence of ketone formation with either positive urine ketones or elevated beta-hydroxybutyrate \> 3
• Anion gap greater than 10 +/ - 2 (or higher than expected anion gap corrected for albumin)
• years of age

You may not qualify if:

• Pregnancy
• Hyperglycemic hyperosmolar state
• Ketosis from other etiology such as starvation or alcoholic ketosis
• Acute exacerbation of congestive heart failure
• Acute coronary syndrome or non-ST elevation MI
• Pulmonary edema from other cause such as decompensated liver failure or acute renal failure
• Renal failure requiring renal replacement therapy (hemodialysis)
• Septic shock

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (5)

• 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.

  PMID: 17130218 BACKGROUND

• 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.

  PMID: 10064682 BACKGROUND

• 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.

  PMID: 23055897 BACKGROUND

• 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.

  PMID: 28878933 BACKGROUND

• 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.

  PMID: 15583776 BACKGROUND

MeSH Terms

Conditions

Diabetic Ketoacidosis

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed (due to COVID19)

Results Point of Contact

• Title: Dr. Chloe Castro
• Organization: The MetroHealth System

ccastro@metrohealth.org

2167784527

Study Officials

• Vidya Krishnan, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Case Western Reserve University

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 6, 2018
• Study Start: September 17, 2018
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: October 31, 2024
• Results First Posted: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)