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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier:
NCT01301274
First received: February 18, 2011
Last updated: March 6, 2012
Last verified: March 2012
  Purpose

The primary objective of this study is to compare the mean serum sodium after 48 hours of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in critically ill children requiring IV maintenance fluid administration.


Condition Intervention
Hyponatremia
Drug: hypotonic
Drug: isotonic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Controlled, Double Blinded, Clinical Trial: 0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children

Resource links provided by NLM:


Further study details as provided by Hospital General de Niños Pedro de Elizalde:

Primary Outcome Measures:
  • Serum Sodium Levels in Both Groups [ Time Frame: first 48 hours ] [ Designated as safety issue: Yes ]
    Mean serum sodium level of each group will be compared at baseline and in the first 48 hours of IV fluid infusion


Secondary Outcome Measures:
  • Mortality at 28 Days [ Time Frame: 28 days after admission ] [ Designated as safety issue: Yes ]
    Mortality in both groups will be compared 28 days after admission

  • Mechanical Ventilation Free Days at 28 Day of Admission [ Time Frame: first 28 day after starting mechanical ventilation ] [ Designated as safety issue: Yes ]
    mechanical ventilation free days at the first 28 day of starting mechanical ventilation, if the patient died the corresponding value is zero.

  • ICU Length of Stay [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    ICU length of stay (in days)


Enrollment: 66
Study Start Date: February 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hypotonic
Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
Drug: hypotonic
0.45% NaCl/5% dextrose IV maintenance fluids
Other Name: half saline/5% dextrose
Experimental: Isotonic
Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
Drug: isotonic
0.9% NaCl/5% dextrose IV maintenance fluids
Other Name: normal saline/5% dextrose

Detailed Description:

In patients without possibilities of oral intake, maintenance fluids provide electrolytes and water. Since the original descriptions by Holliday and Segar, the recommended standard maintenance solutions are based on "physiological needs", containing 30-50 mEq/L of sodium.

However hyponatremia has become increasingly recognized in hospitalized children suggesting that Holliday and Segar's recommendations are frequently inappropriately applied.

It has been described augmented intersticial lung water in patients receiving hypotonic maintenance solutions. Also, hyponatremia has been demonstrated in post-surgery critically ill children receiving hypotonic maintenance solutions.

More over, non-physiologic antidiuretic hormone (ADH) secretion has been described in the great majority of hospitalized children due to nausea, stress, pain, and/or surgical interventions.

It has been suggested that isotonic 0.9% NaCl/dextrose 5% should be the standard maintenance intravenous (IV) solution, to avoid the development of hyponatremia.

There are not studies in critically ill children evaluating the effect of isotonic solutions on sodium levels.

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 1 month to 18 years
  • ICU stay >24 hours
  • Normal seric sodium (135 - 145 mEq/L).
  • Requirement of IV maintenance solutions >80% total fluids intake

Exclusion Criteria:

  • Patients with diagnoses of renal failure (serum creatinine >1 g/dl in <3 years old children, >1,5 in >3 years), hepatic failure with ascitis and portal hypertension, adrenal failure, nephrotic - nephritic syndrome, Kawasaki disease, sickle cell anemia, Syndrome of inappropriate antidiuretic hormone secretion, diabetes insipidus,metabolic disease.
  • Diuretics use in the first 48 hours thereafter indicated IV solutions.
  • Plasma glucose is >200 mg%.
  • Any patients requiring IV fluids therapy different that maintenance (total parenteral nutrition, hyperhydration).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01301274

Locations
Argentina
Hospital General de Niños Pedro de Elizalde
Buenos Aires, Argentina
Sponsors and Collaborators
Hospital General de Niños Pedro de Elizalde
Investigators
Principal Investigator: Facundo A Jorro, MD Hospital General de Niños Pedro de Elizalde
Study Director: Gustavo De Baisi, MD Hospital General de Niños Pedro de Elizalde
Principal Investigator: Susana Bengoa Hospital General de Niños Pedro de Elizalde
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier: NCT01301274     History of Changes
Other Study ID Numbers: HGNPE-20-2011
Study First Received: February 18, 2011
Results First Received: November 16, 2011
Last Updated: March 6, 2012
Health Authority: Argentina: Ministry of Health

Keywords provided by Hospital General de Niños Pedro de Elizalde:
hyponatremia
maintenance solutions
pediatrics

Additional relevant MeSH terms:
Critical Illness
Hyponatremia
Disease Attributes
Pathologic Processes
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on September 11, 2014