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Two Bag System for Diabetic Ketoacidosis

The Two Bag System for Treatment of Adults With Diabetic Ketoacidosis: a Prospective Randomized Study

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03660189
Acronym
2BagDKA
Enrollment
57
Registered
2018-09-06
Start date
2018-09-17
Completion date
2023-06-15
Last updated
2024-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Ketoacidosis

Keywords

intravenous fluids, adults, two bag system

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.

Interventions

OTHERTwo 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.

Sponsors

MetroHealth Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to Anion Gap Closure in Hourswhile in DKAAnion 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).

Secondary

MeasureTime frameDescription
Hypernatremiawhile in DKAMaximum sodium level \> 153 mmol/L
Hyperkalemiawhile in DKAMaximum K level \> 5.3 mmol/L
Number of Participants Experiencing Hypoglycemic Episodeswhile in DKASymptomatic episodes of hypoglycemia
Number of Participants Experiencing Hypoxic Episodeswhile in DKADesaturations less than 89% requiring supplemental oxygen
Pulmonary Edemawhile in DKAPulmonary edema seen on either chest X-ray or with the change in the lung exam
Total Volume of Intravenous Fluids Administeredwhile in DKATotal volume of intravenous fluids administered
Hyponatremia Eventswhile in DKASodium values less than 135 mmol/L (corrected for glucose)
Hypokalemia Eventswhile in DKAPotassium values less than 3.3 mmol/L
ICU Length of Stayduring hospitalizationTotal time the patient was admitted in the stepdown unit and/or medical ICU
Changes in Mental Statuswhile in DKAWorsening in either CAM-ICU score or Glasgow Coma Scale
Chest Pain With EKG Changeswhile in DKAOnset of new chest pain with new EKG changes concerning for ischemia

Countries

United States

Participant flow

Participants by arm

ArmCount
Usual Care
Usual care with a one bag system of IV fluids, as recommended in the American Diabetes Association consensus statement guidelines from 2009.
25
Two Bag System
A two bag system of IV fluids will be used during insulin infusion administration. Two bag system: The two IV fluid bags have identical fluids (normal saline or half normal saline) and electrolytes (optional addition of potassium chloride or potassium phosphate), 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. Total fluid rate (sum of rates of two bags) is 200mL/hour.
32
Total57

Baseline characteristics

CharacteristicUsual CareTwo Bag SystemTotal
Age, Continuous35.2 years
STANDARD_DEVIATION 13.3
38.6 years
STANDARD_DEVIATION 13.6
37.1 years
STANDARD_DEVIATION 13.5
pH on VBG (venous blood gas) at time of presentation7.11 unitless
STANDARD_DEVIATION 0.14
7.09 unitless
STANDARD_DEVIATION 0.14
7.10 unitless
STANDARD_DEVIATION 0.14
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
25 participants32 participants57 participants
Sex: Female, Male
Female
15 Participants21 Participants36 Participants
Sex: Female, Male
Male
10 Participants11 Participants21 Participants
Type of Diabetes (Number of Participants with Type 1 DM)20 Participants19 Participants39 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 250 / 32
other
Total, other adverse events
0 / 250 / 32
serious
Total, serious adverse events
0 / 250 / 32

Outcome results

Primary

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).

Time frame: while in DKA

ArmMeasureGroupValue (MEAN)Dispersion
Usual CareTime to Anion Gap Closure in HoursTime to AG closure (from ED admit)11.2 hoursStandard Deviation 5.1
Usual CareTime to Anion Gap Closure in HoursTime to AG closure (from first BMP)12.0 hoursStandard Deviation 6.7
Two Bag SystemTime to Anion Gap Closure in HoursTime to AG closure (from ED admit)12.2 hoursStandard Deviation 3.9
Two Bag SystemTime to Anion Gap Closure in HoursTime to AG closure (from first BMP)13.5 hoursStandard Deviation 7.7
p-value: 0.54t-test, 2 sided
p-value: 0.44t-test, 2 sided
Secondary

Changes in Mental Status

Worsening in either CAM-ICU score or Glasgow Coma Scale

Time frame: while in DKA

Secondary

Chest Pain With EKG Changes

Onset of new chest pain with new EKG changes concerning for ischemia

Time frame: while in DKA

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareChest Pain With EKG Changes0 Participants
Two Bag SystemChest Pain With EKG Changes0 Participants
Secondary

Hyperkalemia

Maximum K level \> 5.3 mmol/L

Time frame: while in DKA

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareHyperkalemia3 Participants
Two Bag SystemHyperkalemia5 Participants
p-value: 1Fisher Exact
Secondary

Hypernatremia

Maximum sodium level \> 153 mmol/L

Time frame: while in DKA

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareHypernatremia1 Participants
Two Bag SystemHypernatremia2 Participants
p-value: 1Fisher Exact
Secondary

Hypokalemia Events

Potassium values less than 3.3 mmol/L

Time frame: while in DKA

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareHypokalemia Events2 Participants
Two Bag SystemHypokalemia Events5 Participants
p-value: 0.45Fisher Exact
Secondary

Hyponatremia Events

Sodium values less than 135 mmol/L (corrected for glucose)

Time frame: while in DKA

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareHyponatremia Events9 Participants
Two Bag SystemHyponatremia Events12 Participants
p-value: 0.91Fisher Exact
Secondary

ICU Length of Stay

Total time the patient was admitted in the stepdown unit and/or medical ICU

Time frame: during hospitalization

Secondary

Number of Participants Experiencing Hypoglycemic Episodes

Symptomatic episodes of hypoglycemia

Time frame: while in DKA

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants Experiencing Hypoglycemic Episodes0 Participants
Two Bag SystemNumber of Participants Experiencing Hypoglycemic Episodes0 Participants
Secondary

Number of Participants Experiencing Hypoxic Episodes

Desaturations less than 89% requiring supplemental oxygen

Time frame: while in DKA

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareNumber of Participants Experiencing Hypoxic Episodes0 Participants
Two Bag SystemNumber of Participants Experiencing Hypoxic Episodes1 Participants
p-value: 1Fisher Exact
Secondary

Pulmonary Edema

Pulmonary edema seen on either chest X-ray or with the change in the lung exam

Time frame: while in DKA

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CarePulmonary Edema0 Participants
Two Bag SystemPulmonary Edema0 Participants
Secondary

Total Volume of Intravenous Fluids Administered

Total volume of intravenous fluids administered

Time frame: while in DKA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026