Two Bag System for Hydration in Diabetes

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ClinicalTrials.gov Identifier: NCT01631929

Recruitment Status : Terminated (Monitoring Committee found significant & meaningful difference on main outcome)

First Posted : June 29, 2012

Results First Posted : October 26, 2015

Last Update Posted : February 9, 2017

Sponsor:

Information provided by (Responsible Party):

Hospital General de Niños Pedro de Elizalde

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Diabetes Ketoacidosis
Interventions	Other: One bag Other: Two bags
Enrollment	12

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	One Bag	Two Bags
Arm/Group Description	IV infusion of fluids, electrolytes...	Using 2 bags with different solutio...
Arm/Group Description	IV infusion of fluids, electrolytes and dextrose using one bag One bag: Infusion of dextrose and electrolytes using one bag	Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line. Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.
Period Title: Overall Study
Started	6	6
Completed	6	6
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		One Bag	Two Bags	Total
Arm/Group Description		IV infusion of fluids, electrolytes...	Using 2 bags with different solutio...	Total of all reporting groups
Arm/Group Description		IV infusion of fluids, electrolytes and dextrose using one bag One bag: Infusion of dextrose and electrolytes using one bag	Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line. Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.	Total of all reporting groups
Overall Number of Baseline Participants		6	6	12
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	6 participants	6 participants	12 participants
	<=18 years	6 100.0%	6 100.0%	12 100.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	6 participants	6 participants	12 participants
		8.83 (1.7)	9.67 (2.7)	9.2 (3.4)
Gender Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	6 participants	6 participants	12 participants
	Female	5 83.3%	5 83.3%	10 83.3%
	Male	1 16.7%	1 16.7%	2 16.7%
Disease debuted Measure Type: Number Unit of measure: Participants	Number Analyzed	6 participants	6 participants	12 participants
Yes		4	2	6
Not		2	4	6

Outcome Measures

1.Primary Outcome


Title	Time to Achieve Patient Stabilization
Description	Time needed to achieve p...
Description	Time needed to achieve patient stabilization defined by: Plasmatic glucose < 250 mg/dl Blood pH > 7.3 Plasmatic bicarbonate > 15 mmol/L
Time Frame	Participants were followed for the duration of ketoacidosis (an expected average of 12 hours)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	One Bag	Two Bags
Arm/Group Description:	IV infusion of fluids, electrolytes...	Using 2 bags with different solutio...
Arm/Group Description:	IV infusion of fluids, electrolytes and dextrose using one bag One bag: Infusion of dextrose and electrolytes using one bag	Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line. Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.
Overall Number of Participants Analyzed	6	6
Mean (95% Confidence Interval) Unit of Measure: Hours
	13.3 (10.5 to 16.1)	9.8 (8.64 to 10.96)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	One Bag	Two Bags
Arm/Group Description	IV infusion of fluids, electrolytes...	Using 2 bags with different solutio...
Arm/Group Description	IV infusion of fluids, electrolytes and dextrose using one bag One bag: Infusion of dextrose and electrolytes using one bag	Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line. Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.
All-Cause Mortality
	One Bag	Two Bags
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	One Bag	Two Bags
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/6 (0.00%)	0/6 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	One Bag	Two Bags
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/6 (0.00%)	0/6 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Ferreira Juan Pablo MD
Organization:	HOSPITAL GENERAL DE NIÑOS PEDRO DE ELIZALDE
Phone:	+5491136085959
EMail:	ferreirajuanpablo@hotmail.com

Publications of Results:

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.

Other Publications:

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.

Layout table for additonal information

Responsible Party:	Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier:	NCT01631929
Other Study ID Numbers:	65-HGNPE-2012
First Submitted:	June 25, 2012
First Posted:	June 29, 2012
Results First Submitted:	August 19, 2015
Results First Posted:	October 26, 2015
Last Update Posted:	February 9, 2017

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