Diabetic Ketoacidosis2BagDKANCT03660189
Two Bag System for Diabetic Ketoacidosis
A study testing Two bag system in people with Diabetic Ketoacidosis, run by MetroHealth Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetic Ketoacidosis
- What is being tested?
- Two bag system
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2018to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 18-85 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The "Two Bag" System for Treatment of Adults With Diabetic Ketoacidosis: a Prospective Randomized Study
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.
Read the 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
- Being tested
- Two bag system
- Keywords
- intravenous fluids, adults, two bag system
- Medical subject headings
- Diabetic Ketoacidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two bag systemOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Two bag system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: while in DKA
Secondary outcomes (11)
Number of Participants Experiencing Hypoglycemic Episodes
Symptomatic episodes of hypoglycemia
Measured: while in DKA
Number of Participants Experiencing Hypoxic Episodes
Desaturations less than 89% requiring supplemental oxygen
Measured: while in DKA
Pulmonary Edema
Pulmonary edema seen on either chest X-ray or with the change in the lung exam
Measured: while in DKA
Chest Pain With EKG Changes
Onset of new chest pain with new EKG changes concerning for ischemia
Measured: while in DKA
Hyponatremia Events
Sodium values less than 135 mmol/L (corrected for glucose)
Measured: while in DKA
Hypokalemia Events
Potassium values less than 3.3 mmol/L
Measured: while in DKA
ICU Length of Stay
Total time the patient was admitted in the stepdown unit and/or medical ICU
Measured: during hospitalization
Changes in Mental Status
Worsening in either CAM-ICU score or Glasgow Coma Scale
Measured: while in DKA
Total Volume of Intravenous Fluids Administered
Total volume of intravenous fluids administered
Measured: while in DKA
Hypernatremia
Maximum sodium level > 153 mmol/L
Measured: while in DKA
Hyperkalemia
Maximum K level > 5.3 mmol/L
Measured: while in DKA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start17 Sep 2018
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Why it stopped: COVID19 restrictions impeded our ability to recruit patients further
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vidya Krishnan, MetroHealth Medical Center
- Investigators
- Vidya Krishnan, MD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660189
- Sponsor's protocol ID
- IRB18-00025
- Acronym
- 2BagDKA
- Status last verified
- Oct 2024
- First submitted
- 4 Sep 2018
- Last updated
- 31 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan to share individual participant data at this time.
Publications
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.
PubMed 17130218Grimberg 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.
PubMed 10064682So 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.
PubMed 23055897Munir 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.
PubMed 28878933Poirier 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.
PubMed 15583776
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "Two Bag" System for Treatment of Adults With Diabetic Ketoacidosis: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03660189
- Acronym / sponsor ID
- 2BagDKA / IRB18-00025
- Conditions
- Diabetic Ketoacidosis
- Keywords
- intravenous fluids, adults, two bag system
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID19 restrictions impeded our ability to recruit patients further
- Enrolment
- 57 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Posted 31 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Two bag systemA two bag system of IV fluids will be used during insulin infusion administration. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of diabetic ketoacidosis defined as:
- 18-85 years of age
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two bag systemThe 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. | Other | Two bag system |
Primary outcome
Time to Anion Gap Closure in Hours
Time frame: while in DKA
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).
11 secondary outcomes
Number of Participants Experiencing Hypoglycemic Episodes
Time frame: while in DKA
Number of Participants Experiencing Hypoxic Episodes
Time frame: while in DKA
Pulmonary Edema
Time frame: while in DKA
Chest Pain With EKG Changes
Time frame: while in DKA
Hyponatremia Events
Time frame: while in DKA
Hypokalemia Events
Time frame: while in DKA
ICU Length of Stay
Time frame: during hospitalization
Changes in Mental Status
Time frame: while in DKA
Total Volume of Intravenous Fluids Administered
Time frame: while in DKA
Hypernatremia
Time frame: while in DKA
Hyperkalemia
Time frame: while in DKA
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17130218Kitabchi 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.
- Background: PubMed 10064682Grimberg 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.
- Background: PubMed 23055897So 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.
- Background: PubMed 28878933Munir 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.
- Background: PubMed 15583776Poirier 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.
- Individual participant dataSharing planned: No. No current plan to share individual participant data at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vidya Krishnan, MD principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two bag system in people with Diabetic Ketoacidosis, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Anion Gap Closure in Hours (time frame: while in DKA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03660189, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.