Trial Outcomes & Findings for 0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children (NCT NCT01301274)

NCT ID: NCT01301274

Last Updated: 2012-03-07

Results Overview

Mean serum sodium level of each group will be compared at baseline and in the first 48 hours of IV fluid infusion

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 66 participants
• Primary outcome timeframe: first 48 hours
• Results posted on: 2012-03-07

Participant Flow

Intensive Care Unit without cardiovascular patients, since 01/02/2011 until 01/11/2011

251 admitted patients to ICU, 97 eligible patients, 9 patients did not give consent, 22 were not randomized by treatment physician

Participant milestones

Measure	Hypotonic Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.	Isotonic Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
Overall Study STARTED	34	32
Overall Study COMPLETED	32	31
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Hypotonic Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.	Isotonic Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
Overall Study Physician Decision	2	1

Baseline Characteristics

0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children

Baseline characteristics by cohort

Measure	Hypotonic n=34 Participants Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.	Isotonic n=32 Participants Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	34 Participants n=5 Participants	32 Participants n=7 Participants	66 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	3 years STANDARD_DEVIATION 4.7 • n=5 Participants	1.2 years STANDARD_DEVIATION 3.2 • n=7 Participants	2.2 years STANDARD_DEVIATION 4.1 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment Argentina	34 participants n=5 Participants	32 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: first 48 hours

Mean serum sodium level of each group will be compared at baseline and in the first 48 hours of IV fluid infusion

Outcome measures

Measure	Hypotonic Arm n=32 Participants patients who received for maintenance solution 0.45% ClNa in Dx 5%	Isotonic Arm n=31 Participants Patients who received for maintenance solution 0.9% ClNa in Dx 5%
Serum Sodium Levels in Both Groups	137.8 mEq/L Standard Deviation 4.3	140.0 mEq/L Standard Deviation 4.1

SECONDARY outcome

Timeframe: 28 days after admission

Population: The analysis was per intention to treat

Mortality in both groups will be compared 28 days after admission

Outcome measures

Measure	Hypotonic Arm n=32 Participants patients who received for maintenance solution 0.45% ClNa in Dx 5%	Isotonic Arm n=31 Participants Patients who received for maintenance solution 0.9% ClNa in Dx 5%
Mortality at 28 Days	3 participants	0 participants

SECONDARY outcome

Timeframe: first 28 day after starting mechanical ventilation

mechanical ventilation free days at the first 28 day of starting mechanical ventilation, if the patient died the corresponding value is zero.

Outcome measures

Measure	Hypotonic Arm n=32 Participants patients who received for maintenance solution 0.45% ClNa in Dx 5%	Isotonic Arm n=31 Participants Patients who received for maintenance solution 0.9% ClNa in Dx 5%
Mechanical Ventilation Free Days at 28 Day of Admission	19.9 days Standard Deviation 7.9	21.5 days Standard Deviation 6.6

SECONDARY outcome

Timeframe: 180 days

ICU length of stay (in days)

Outcome measures

Measure	Hypotonic Arm n=32 Participants patients who received for maintenance solution 0.45% ClNa in Dx 5%	Isotonic Arm n=31 Participants Patients who received for maintenance solution 0.9% ClNa in Dx 5%
ICU Length of Stay	8.5 days Standard Deviation 5.5	11.9 days Standard Deviation 11.5

Adverse Events

Hypotonic

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Isotonic

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Hypotonic n=34 participants at risk Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.	Isotonic n=32 participants at risk Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
General disorders hyponatremia <130 mEq/l	2.9% 1/34 • Number of events 1 • until they were receiving the maintenance solution, mean time 24 hours up to 48 hours. The adverse events were collected up to PICU discharged, mean time 7.4 days, except mortality up to 28 days.	0.00% 0/32 • until they were receiving the maintenance solution, mean time 24 hours up to 48 hours. The adverse events were collected up to PICU discharged, mean time 7.4 days, except mortality up to 28 days.
General disorders Death	8.8% 3/34 • Number of events 3 • until they were receiving the maintenance solution, mean time 24 hours up to 48 hours. The adverse events were collected up to PICU discharged, mean time 7.4 days, except mortality up to 28 days.	0.00% 0/32 • until they were receiving the maintenance solution, mean time 24 hours up to 48 hours. The adverse events were collected up to PICU discharged, mean time 7.4 days, except mortality up to 28 days.

Other adverse events

Measure	Hypotonic n=34 participants at risk Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.	Isotonic n=32 participants at risk Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
General disorders Serum sodium < 135 mEq/l	14.7% 5/34 • Number of events 5 • until they were receiving the maintenance solution, mean time 24 hours up to 48 hours. The adverse events were collected up to PICU discharged, mean time 7.4 days, except mortality up to 28 days.	12.5% 4/32 • Number of events 4 • until they were receiving the maintenance solution, mean time 24 hours up to 48 hours. The adverse events were collected up to PICU discharged, mean time 7.4 days, except mortality up to 28 days.

Additional Information

Dr Facundo Jorro Barón

Intensive Care Unit - Hospital Pedro de Elizalde

Phone: 00541143632100

Email: jorrobox@yahoo.com.ar

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place