Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children

NCT01251770 | Completed Phase 3 Results DMC

• 1 other identifier: HGNPE-15-2010
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare the blood sodium level after 12 hours following the initiation of therapy with either 0.3% NaCl/dextrose 5% or 0.45% NaCl/dextrose 5%, in postsurgical hospitalized children requiring maintenance IV fluid administration.

Conditions

Hyponatremia

Keywords

Hyponatremia; Water-Electrolyte Imbalance

Outcome Measures

Primary Outcomes (1)

• Change in Sodium Levels

  Change from baseline in sodium level after 12 hours

Secondary Outcomes (1)

• IV Fluid Intake

  12 hours from baseline

Study Arms (2)

half saline

EXPERIMENTAL

Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids.

Drug: 0.45% NaCl/dextrose 5%

third saline

ACTIVE COMPARATOR

Subjects in this arm will receive 0.3% NaCl/dextrose 5% intravenous (IV) maintenance fluids.

Drug: 0.3% NaCl/dextrose 5%

Interventions

0.45% NaCl/dextrose 5% DRUG

Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids.Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m\^2 body surface.

Also known as: half saline

half saline

0.3% NaCl/dextrose 5% DRUG

Drug: 0.3% NaCl/dextrose 5% IV maintenance fluids. Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m\^2 surface.

Also known as: third saline

third saline

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Postsurgical children admitted to HGNPE Department of Surgery between january 2010 and october 2011.
• Aged 1 month to 16 years. Initial plasma Na between 135-145 mmol/L. Primary route of fluid administration is anticipated to be intravenous, in the first 12 hours following surgery.
• Informed consent of parent/guardian.

You may not qualify if:

• Children with illness that have primary fluid and electrolyte imbalance such as:
• Shock: Defined as acute circulatory failure resulting in decreased tissue perfusion and manifesting as altered sensorium, hypothermia (\<35oC), tachycardia, prolonged capillary filling time (\>3 seconds), hypotension (BP \< 5th percentile for age), oliguria (\<0.5 ml/kg/hr), hypoxemia, hyperlactatemia, requirement of fluid bolus and/ or vasopressors.
• Diarrhea and Dehydration: Children presenting with diarrhea and features of dehydration: lethargy, irritability and altered sensorium, thirst, decreased urine output, sunken eyes \& dry mucous membranes, loss of skin elasticity.; children with ongoing diarrhea will be excluded even if there is no dehydration.
• Fluid Overload: Cirrhosis, Congestive heart failure, Acute and Chronic renal failure, Nephrotic syndrome.
• Hyperglycemia: blood glucose \> 180 mg/ dl.
• Require ICU admission.
• Severe Protein Energy Malnutrition: Defined as grade III (50-59% of expected weight for age) and grade IV (less than 50% of expected weight for age) as per IAP classification.
• Patients in whom either hypotonic or isotonic solutions may be contraindicated/necessary: i.e. specific neurosurgical patients (ie those at risk of increased ICP, e.g. requiring actual brain surgery, ICP monitor or external ventricular drain insertion), patients with diabetic ketoacidosis, acute (≤ 7 days) burns, pre-existing CHF, liver failure or cirrhosis, renal failure.
• Patients with known pre-existing risk of PNa derangements: DI or SIADH

Sponsors & Collaborators

• Hospital General de Niños Pedro de Elizalde: lead

Study Sites (1)

Hospital de Niños Pedro de Elizalde

Buenos Aires, Buenos Aires F.D., C1270AAN, Argentina

Location

Related Publications (3)

• Choong K, Kho ME, Menon K, Bohn D. Hypotonic versus isotonic saline in hospitalised children: a systematic review. Arch Dis Child. 2006 Oct;91(10):828-35. doi: 10.1136/adc.2005.088690. Epub 2006 Jun 5.

  PMID: 16754657 BACKGROUND

• Neville KA, Sandeman DJ, Rubinstein A, Henry GM, McGlynn M, Walker JL. Prevention of hyponatremia during maintenance intravenous fluid administration: a prospective randomized study of fluid type versus fluid rate. J Pediatr. 2010 Feb;156(2):313-9.e1-2. doi: 10.1016/j.jpeds.2009.07.059. Epub 2009 Oct 9.

  PMID: 19818450 BACKGROUND

• Yung M, Keeley S. Randomised controlled trial of intravenous maintenance fluids. J Paediatr Child Health. 2009 Jan-Feb;45(1-2):9-14. doi: 10.1111/j.1440-1754.2007.01254.x. Epub 2007 Nov 25.

  PMID: 18036144 BACKGROUND

Related Links

• Hyponatremia treatment guidelines 2007: expert panel recommendations

MeSH Terms

Conditions

Hyponatremia; Water-Electrolyte Imbalance

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr Facundo Jorro Barón
• Organization: Hospital General de Niños Pedro de Elizalde

jorrobox@yahoo.com.ar

00541143632100

Study Officials

• Manuela Dicembrino, md

  Hospital de Niños Pedro de Elizalde

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 2, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 3, 2017
• Results First Posted: January 25, 2012

Record last verified: 2017-01

Locations

AR (1)