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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

Recruitment Details  
Pre-assignment Details  
Arm/Group Title One Bag Two Bags
Hide 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
Arm/Group Title One Bag Two Bags Total
Hide 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
Hide 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
1.Primary Outcome
Title Time to Achieve Patient Stabilization
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title One Bag Two Bags
Hide 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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title One Bag Two Bags
Hide 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   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
One Bag Two Bags
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide 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%) 
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
Name/Title: Ferreira Juan Pablo MD
Organization: HOSPITAL GENERAL DE NIÑOS PEDRO DE ELIZALDE
Phone: +5491136085959
Responsible Party: Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier: NCT01631929     History of Changes
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