Trial Outcomes & Findings for Maintenance Intravenous Fluids in Children (NCT NCT00621348)

NCT ID: NCT00621348

Last Updated: 2011-08-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 167 participants
• Primary outcome timeframe: 72 hrs
• Results posted on: 2011-08-10

Participant Flow

Enrollment: September 2006 to April 2008 Analysis: May and June 2008 Pediatric ward and Pediatric intensive care unit in a tertiary care referral hospital in North India

Patients were stratified based on their age in to three groups (age 3 months to 1 year, 1-5 years, 6-12 years) and stratified randomization was used.

Participant milestones

Measure	Dextrose Normal Saline Normal saline in 5% dextrose at standard maintenance rate	Fluid Restriction Group Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose	Hypotonic Saline N/5 saline in 5% dextrose at standard maintenance rate
Overall Study STARTED	58	53	56
Overall Study COMPLETED	58	53	56
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Maintenance Intravenous Fluids in Children

Baseline characteristics by cohort

Measure	Dextrose Normal Saline n=58 Participants Normal saline in 5% dextrose at standard maintenance rate	Fluid Restriction Group n=53 Participants Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose	Hypotonic Saline n=56 Participants N/5 saline in 5% dextrose at standard maintenance rate	Total n=167 Participants Total of all reporting groups
Age, Categorical <=18 years	58 Participants n=5 Participants	53 Participants n=7 Participants	56 Participants n=5 Participants	167 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	3 years STANDARD_DEVIATION 0.44 • n=5 Participants	3 years STANDARD_DEVIATION 0.36 • n=7 Participants	4 years STANDARD_DEVIATION 0.28 • n=5 Participants	3.33 years STANDARD_DEVIATION 0.56 • n=4 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	35 Participants n=7 Participants	43 Participants n=5 Participants	114 Participants n=4 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	18 Participants n=7 Participants	13 Participants n=5 Participants	53 Participants n=4 Participants
Region of Enrollment India	58 participants n=5 Participants	53 participants n=7 Participants	56 participants n=5 Participants	167 participants n=4 Participants

PRIMARY outcome

Timeframe: 72 hrs

Population: 432 patients were eligible. 203 patients were excluded and 62 patients declined consent . Out of 167 patients, 58 patients were randomized to Arm 1, 53 to arm 2 and 56 to arm 3.Intention to treat analysis was used.

Outcome measures

Measure	Dextrose Normal Saline n=58 Participants Normal saline in 5% dextrose at standard maintenance rate	Fluid Restriction Group n=53 Participants Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose	Hypotonic Saline n=56 Participants N/5 saline in 5% dextrose at standard maintenance rate
Incidence of Hyponatremia (Defined as Serum Sodium Less Than 130 mmol/L)	1 participants	2 participants	8 participants

SECONDARY outcome

Timeframe: 72 hrs

Population: Intention To Treat analysis

Outcome measures

Measure	Dextrose Normal Saline n=58 Participants Normal saline in 5% dextrose at standard maintenance rate	Fluid Restriction Group n=53 Participants Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose	Hypotonic Saline n=56 Participants N/5 saline in 5% dextrose at standard maintenance rate
Incidence of Hypernatremia (Serum Sodium >150 mmol/L)	2 participants	4 participants	2 participants

SECONDARY outcome

Timeframe: 72 hrs

Defined as Hyponatremia (serum sodium < 130 mnol/L)and presence of symptoms attributed to hyponatremia such as altered sensorium, seizure, headache, and vomiting which can not be explained otherwise.

Outcome measures

Measure	Dextrose Normal Saline n=58 Participants Normal saline in 5% dextrose at standard maintenance rate	Fluid Restriction Group n=53 Participants Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose	Hypotonic Saline n=56 Participants N/5 saline in 5% dextrose at standard maintenance rate
Incidence of Symptomatic Hyponatremia	0 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: 72 hrs

Population: Intention to Treat analysis

Symptomatic hypernatremia is defined as serum sodium > 150 mmol/L and the presence of symptoms like altered sensorium, seizure, headache and vomiting not explained otherwise.

Outcome measures

Measure	Dextrose Normal Saline n=58 Participants Normal saline in 5% dextrose at standard maintenance rate	Fluid Restriction Group n=53 Participants Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose	Hypotonic Saline n=56 Participants N/5 saline in 5% dextrose at standard maintenance rate
Incidence of Symptomatic Hypernatremia	0 participants	0 participants	0 participants

Adverse Events

Dextrose Normal Saline

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Fluid Restriction Group

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Hypotonic Saline

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dextrose Normal Saline n=58 participants at risk Normal saline in 5% dextrose at standard maintenance rate	Fluid Restriction Group n=53 participants at risk Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose	Hypotonic Saline n=56 participants at risk N/5 saline in 5% dextrose at standard maintenance rate
Nervous system disorders Death or symptomatic hyponatremia	1.7% 1/58 • Number of events 1	1.9% 1/53 • Number of events 1	0.00% 0/56

Other adverse events

Measure	Dextrose Normal Saline n=58 participants at risk Normal saline in 5% dextrose at standard maintenance rate	Fluid Restriction Group n=53 participants at risk Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose	Hypotonic Saline n=56 participants at risk N/5 saline in 5% dextrose at standard maintenance rate
Renal and urinary disorders Hypernatremia	3.4% 2/58 • Number of events 2	7.5% 4/53 • Number of events 4	3.6% 2/56 • Number of events 2

Additional Information

Rakesh Lodha

AIIMS

Phone: 91 11 26593621

Email: rakesh_lodha@hotmail.com

Results disclosure agreements

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