Maintenance Intravenous Fluids in Children

NCT00621348 | Completed Phase 3 Results

• 1 other identifier: RL-1
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

Hyponatraemia arises in between 20% and 45% of sick hospitalized children. An important reason for this high incidence could be use of hypotonic fluids in sick children for maintenance fluid therapy. There are no randomized controlled trials to evaluate the effect of various types of intravenous fluids on the incidence of hyponatremia in sick hospitalized children. Hypothesis: Use of normal saline in 5% dextrose or reduced (2/3) volume of N/5 saline in 5% dextrose reduces incidence of hyponatremia (serum sodium 130 mmol/L) by two-thirds when compared to N/5 saline in 5% dextrose at standard maintenance rate in hospitalized children receiving intravenous maintenance fluids.

Conditions

Hyponatremia

Keywords

maintenance fluids; hyponatremia; vasopressin; children

Outcome Measures

Primary Outcomes (1)

• Incidence of Hyponatremia (Defined as Serum Sodium Less Than 130 mmol/L)

  72 hrs

Secondary Outcomes (3)

• Incidence of Hypernatremia (Serum Sodium >150 mmol/L)

  72 hrs

• Incidence of Symptomatic Hyponatremia

  72 hrs

• Incidence of Symptomatic Hypernatremia

  72 hrs

Study Arms (3)

Isotonic fluid group

ACTIVE COMPARATOR

Normal saline in 5% dextrose at standard maintenance rate

Drug: Isotonic fluid

Fluid restriction group

ACTIVE COMPARATOR

Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose

Drug: Hypotonic fluid

Hypotonic fluid group

ACTIVE COMPARATOR

N/5 saline in 5% dextrose at standard maintenance rate

Drug: Hypotonic fluid

Interventions

Isotonic fluid DRUG

0.9% saline with 5% dextrose at standard maintenance rate

Also known as: Dextrose normal saline

Isotonic fluid group

Hypotonic fluid DRUG

Reduced volume (two thirds of standard maintenance rate) of N/5 saline in 5% dextrose

Also known as: Hypotonic fluid,, 0.2 % saline in 5 % dextrose

Fluid restriction group

Eligibility Criteria

• Age: 3 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All children (3 months to 12 years) who are admitted to pediatric ward or pediatric ICU, who require exclusive intravenous maintenance fluid therapy for at least 24 hours will be eligible for the study

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.
• Abnormal serum sodium or Hyperglycemia at Presentation:
• Hyponatremia : serum sodium \< 130 mmol/L.
• Hypernatremia : serum sodium \>150 mmol/L.
• Hyperglycemia: blood glucose \> 180 mg/ dl.
• 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.
• Child who is receiving drugs which cause abnormality in serum sodium such as diuretics, vasopressin, etc.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Related Publications (1)

• Kannan L, Lodha R, Vivekanandhan S, Bagga A, Kabra SK, Kabra M. Intravenous fluid regimen and hyponatraemia among children: a randomized controlled trial. Pediatr Nephrol. 2010 Nov;25(11):2303-9. doi: 10.1007/s00467-010-1600-4. Epub 2010 Jul 29.

  PMID: 20668885 RESULT

MeSH Terms

Conditions

Hyponatremia; Diabetes Insipidus

Interventions

Sodium Chloride; Glucose

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates

Results Point of Contact

• Title: Rakesh Lodha
• Organization: AIIMS

rakesh_lodha@hotmail.com

91 11 26593621

Study Officials

• Rakesh Lodha, MD

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: February 22, 2008
• Study Start: September 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: May 1, 2008
• Last Updated: August 10, 2011
• Results First Posted: August 5, 2011

Record last verified: 2011-08

Locations

IN (1)