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COVID19 restrictions impeded our ability to recruit patients further
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Hypoglycemic Episodes | Symptomatic episodes of hypoglycemia | while in DKA |
| Number of Participants Experiencing Hypoxic Episodes | Desaturations less than 89% requiring supplemental oxygen |
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Inclusion Criteria:
Diagnosis of diabetic ketoacidosis defined as:
18-85 years of age
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vidya Krishnan, MD | MetroHealth Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17130218 | Background | 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. | |
| 10064682 | 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. |
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No current plan to share individual participant data at this time.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Usual care with a one bag system of IV fluids, as recommended in the American Diabetes Association consensus statement guidelines from 2009. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Usual care with a one bag system of IV fluids, as recommended in the American Diabetes Association consensus statement guidelines from 2009. |
| BG001 | Two Bag System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | hours | while in DKA |
|
During the index hospitalization - from time of onset of DKA (time of ED check-in or time of first BMP, whichever is first) through the resolution of the DKA. This would be an average of about 12 hours, and a maximum of 48.5 hours.
Review of EMR
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Usual care with a one bag system of IV fluids, as recommended in the American Diabetes Association consensus statement guidelines from 2009. |
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Early termination leading to small numbers of subjects analyzed (due to COVID19)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chloe Castro | The MetroHealth System | 2167784527 | ccastro@metrohealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2018 | Jul 7, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016883 | Diabetic Ketoacidosis |
| ID | Term |
|---|---|
| D007662 | Ketosis |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| while in DKA |
| Pulmonary Edema | Pulmonary edema seen on either chest X-ray or with the change in the lung exam | while in DKA |
| Chest Pain With EKG Changes | Onset of new chest pain with new EKG changes concerning for ischemia | while in DKA |
| Hyponatremia Events | Sodium values less than 135 mmol/L (corrected for glucose) | while in DKA |
| Hypokalemia Events | Potassium values less than 3.3 mmol/L | while in DKA |
| ICU Length of Stay | Total time the patient was admitted in the stepdown unit and/or medical ICU | during hospitalization |
| Changes in Mental Status | Worsening in either CAM-ICU score or Glasgow Coma Scale | while in DKA |
| Total Volume of Intravenous Fluids Administered | Total volume of intravenous fluids administered | while in DKA |
| Hypernatremia | Maximum sodium level > 153 mmol/L | while in DKA |
| Hyperkalemia | Maximum K level > 5.3 mmol/L | while in DKA |
| 23055897 | 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. |
| 28878933 | 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. |
| 15583776 | 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. |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type of Diabetes (Number of Participants with Type 1 DM) | Count of Participants | Participants |
|
| pH on VBG (venous blood gas) at time of presentation | range from 0 to 14, 7.0 is neutral | Initial VBG unavailable for 1 participant in the usual care group. | Mean | Standard Deviation | unitless |
|
|
|
|
| Secondary | Number of Participants Experiencing Hypoglycemic Episodes | Symptomatic episodes of hypoglycemia | Posted | Count of Participants | Participants | while in DKA |
|
|
|
| Secondary | Number of Participants Experiencing Hypoxic Episodes | Desaturations less than 89% requiring supplemental oxygen | Posted | Count of Participants | Participants | while in DKA |
|
|
|
|
| Secondary | Pulmonary Edema | Pulmonary edema seen on either chest X-ray or with the change in the lung exam | Posted | Count of Participants | Participants | while in DKA |
|
|
|
| Secondary | Chest Pain With EKG Changes | Onset of new chest pain with new EKG changes concerning for ischemia | Posted | Count of Participants | Participants | while in DKA |
|
|
|
| Secondary | Hyponatremia Events | Sodium values less than 135 mmol/L (corrected for glucose) | Posted | Count of Participants | Participants | while in DKA |
|
|
|
|
| Secondary | Hypokalemia Events | Potassium values less than 3.3 mmol/L | Posted | Count of Participants | Participants | while in DKA |
|
|
|
|
| Secondary | ICU Length of Stay | Total time the patient was admitted in the stepdown unit and/or medical ICU | Not Posted | during hospitalization | Participants |
| Secondary | Changes in Mental Status | Worsening in either CAM-ICU score or Glasgow Coma Scale | Not Posted | while in DKA | Participants |
| Secondary | Total Volume of Intravenous Fluids Administered | Total volume of intravenous fluids administered | Not Posted | while in DKA | Participants |
| Secondary | Hypernatremia | Maximum sodium level > 153 mmol/L | Posted | Count of Participants | Participants | while in DKA |
|
|
|
|
| Secondary | Hyperkalemia | Maximum K level > 5.3 mmol/L | Posted | Count of Participants | Participants | while in DKA |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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. | 0 | 32 | 0 | 32 | 0 | 32 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |