Trial Outcomes & Findings for Two Bag System for Diabetic Ketoacidosis (NCT NCT03660189)

Results Overview

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).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

57 participants

Primary outcome timeframe

while in DKA

Results posted on

2024-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care 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 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.
Overall Study STARTED	25	32
Overall Study COMPLETED	25	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=25 Participants 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 n=32 Participants 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.	Total n=57 Participants Total of all reporting groups
Age, Continuous	35.2 years STANDARD_DEVIATION 13.3 • n=25 Participants	38.6 years STANDARD_DEVIATION 13.6 • n=32 Participants	37.1 years STANDARD_DEVIATION 13.5 • n=57 Participants
Sex: Female, Male Female	15 Participants n=25 Participants	21 Participants n=32 Participants	36 Participants n=57 Participants
Sex: Female, Male Male	10 Participants n=25 Participants	11 Participants n=32 Participants	21 Participants n=57 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	25 participants n=25 Participants	32 participants n=32 Participants	57 participants n=57 Participants
Type of Diabetes (Number of Participants with Type 1 DM)	20 Participants n=25 Participants	19 Participants n=32 Participants	39 Participants n=57 Participants
pH on VBG (venous blood gas) at time of presentation	7.11 unitless STANDARD_DEVIATION 0.14 • n=24 Participants • Initial VBG unavailable for 1 participant in the usual care group.	7.09 unitless STANDARD_DEVIATION 0.14 • n=32 Participants • Initial VBG unavailable for 1 participant in the usual care group.	7.10 unitless STANDARD_DEVIATION 0.14 • n=56 Participants • Initial VBG unavailable for 1 participant in the usual care group.

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Usual Care n=25 Participants 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 n=32 Participants 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.
Time to Anion Gap Closure in Hours Time to AG closure (from ED admit)	11.2 hours Standard Deviation 5.1	12.2 hours Standard Deviation 3.9
Time to Anion Gap Closure in Hours Time to AG closure (from first BMP)	12.0 hours Standard Deviation 6.7	13.5 hours Standard Deviation 7.7

SECONDARY outcome

Timeframe: while in DKA

Symptomatic episodes of hypoglycemia

Outcome measures

Outcome measures
Measure	Usual Care n=25 Participants 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 n=32 Participants 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.
Number of Participants Experiencing Hypoglycemic Episodes	0 Participants	0 Participants

SECONDARY outcome

Timeframe: while in DKA

Desaturations less than 89% requiring supplemental oxygen

Outcome measures

Outcome measures
Measure	Usual Care n=25 Participants 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 n=32 Participants 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.
Number of Participants Experiencing Hypoxic Episodes	0 Participants	1 Participants

SECONDARY outcome

Timeframe: while in DKA

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

Outcome measures

Outcome measures
Measure	Usual Care n=25 Participants 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 n=32 Participants 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.
Pulmonary Edema	0 Participants	0 Participants

SECONDARY outcome

Timeframe: while in DKA

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

Outcome measures

Outcome measures
Measure	Usual Care n=25 Participants 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 n=32 Participants 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.
Chest Pain With EKG Changes	0 Participants	0 Participants

SECONDARY outcome

Timeframe: while in DKA

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

Outcome measures

Outcome measures
Measure	Usual Care n=25 Participants 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 n=32 Participants 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.
Hyponatremia Events	9 Participants	12 Participants

SECONDARY outcome

Timeframe: while in DKA

Potassium values less than 3.3 mmol/L

Outcome measures

Outcome measures
Measure	Usual Care n=25 Participants 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 n=32 Participants 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.
Hypokalemia Events	2 Participants	5 Participants

SECONDARY outcome

Timeframe: during hospitalization

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: while in DKA

Worsening in either CAM-ICU score or Glasgow Coma Scale

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: while in DKA

Total volume of intravenous fluids administered

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: while in DKA

Maximum sodium level \> 153 mmol/L

Outcome measures

Outcome measures
Measure	Usual Care n=25 Participants 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 n=32 Participants 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.
Hypernatremia	1 Participants	2 Participants

SECONDARY outcome

Timeframe: while in DKA

Maximum K level \> 5.3 mmol/L

Outcome measures

Outcome measures
Measure	Usual Care n=25 Participants 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 n=32 Participants 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.
Hyperkalemia	3 Participants	5 Participants

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Two Bag System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Chloe Castro

The MetroHealth System

Phone: 2167784527

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place