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Two bag system for Diabetic Ketoacidosis (2BagDKA Trial)

N/A
Waitlist Available
Led By Vidya Krishnan, MD
Research Sponsored by MetroHealth Medical Center
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 during hospitalization
Awards & highlights

2BagDKA Trial Summary

This trial is investigating whether treating DKA with two IV bags of fluids leads to a shorter time requiring treatment with intravenous insulin, when compared to the traditional one bag system.

Eligible Conditions
  • Diabetic Ketoacidosis

2BagDKA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during hospitalization
This trial's timeline: 3 weeks for screening, Varies for treatment, and during hospitalization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to anion gap closure in hours
Secondary outcome measures
Changes in mental status
Chest pain with EKG changes
Hypoglycemic episodes
+6 more

2BagDKA Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Two bag systemExperimental Treatment1 Intervention
A two bag system of IV fluids will be used during insulin infusion administration.
Group II: Usual careActive Control1 Intervention
Usual care with a one bag system of IV fluids, as recommended in the American Diabetes Association consensus statement guidelines from 2009.

Find a Location

Who is running the clinical trial?

MetroHealth Medical CenterLead Sponsor
114 Previous Clinical Trials
21,332 Total Patients Enrolled
Vidya Krishnan, MDPrincipal InvestigatorMetroHealth Medical Center
1 Previous Clinical Trials
30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are joining this research project?

"Affirmative, according to clinicaltrials.gov this investigation is presently recruiting individuals. The protocol was initially posted on September 17th 2018 and the most recent update dates back to September 16th 2022. There are 100 participants needed from one centre of study."

Answered by AI

Is this trial still searching for participants?

"Affirmative. According to information on clinicaltrials.gov, this research study is presently seeking volunteers and has been since its posting in September 2018. 100 participants are expected from a single medical centre."

Answered by AI

What criteria must prospective participants fulfill to be eligible for inclusion in this trial?

"This clinical trial is recruiting 100 people with diabetic ketoacidosis aged 18 to 85. The essential characteristics for eligibility are anion gap greater than 10 +/- 2, blood sugar over 250 milligrams per deciliter, venous pH lower than 7.25, bicarbonate levels beneath 18, either positive urine ketones or elevated beta-hydroxybutyrate above 3 and age between 18 to 85 years old."

Answered by AI

Is there an age cutoff for participating in this medical experiment?

"Only individuals aged between 18 - 85 are eligible to participate in this clinical trial. For those under the age of 18, there are 4 alternative trials available and for those over 65, 27 options exist."

Answered by AI
Recent research and studies
Diabetes CareJournal
Hyperglycemic Crises in Adult Patients with Diabetes
Kitabchi, Abbas E., Guillermo E. Umpierrez, Mary Beth Murphy, and Robert A. Kreisberg. 2006. “Hyperglycemic Crises in Adult Patients with Diabetes”. Diabetes Care. American Diabetes Association. doi:10.2337/dc06-9916.
The Journal of Pediatric Pharmacology and TherapeuticsJournal
Evaluation of the Two-bag System for Fluid Management in Pediatric Patients with Diabetic Ketoacidosis
So, Tsz-Yin, and Elizabeth Grunewalder. 2009. “Evaluation of the Two-bag System for Fluid Management in Pediatric Patients with Diabetic Ketoacidosis”. The Journal of Pediatric Pharmacology and Therapeutics. Pediatric Pharmacy Advocacy Group. doi:10.5863/1551-6776-14.2.100.
The Journal of PediatricsJournal
The “two Bag System
Grimberg, Adda, Ruben W. Cerri, Marta Satin-Smith, and Pinchas Cohen. 1999. “The “two Bag System” for Variable Intravenous Dextrose and Fluid Administration: Benefits in Diabetic Ketoacidosis Management”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/s0022-3476(99)70469-5.
BMJ Open Diabetes Research & CareJournal
Comparison of a ‘two-bag System’ Versus Conventional Treatment Protocol (‘one-bag System’) in the Management of Diabetic Ketoacidosis
Munir, Iqbal, Ramiz Fargo, Roger Garrison, Almira Yang, Andy Cheng, Ilho Kang, Ali Motabar, Karen Xu, Lawrence K Loo, and Daniel I Kim. 2017. “Comparison of a ‘two-bag System’ Versus Conventional Treatment Protocol (‘one-bag System’) in the Management of Diabetic Ketoacidosis”. BMJ Open Diabetes Research & Care. BMJ. doi:10.1136/bmjdrc-2017-000395.
~9 spots leftby Apr 2025
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