Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

February 18, 2011
March 6, 2012
February 2011
November 2011   (final data collection date for primary outcome measure)
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
serum sodium levels in both groups [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
Mean serum sodium level of each group will be compared at baseline and after 48 hours of IV fluid infusion
Complete list of historical versions of study NCT01301274 on ClinicalTrials.gov Archive Site
  • 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)
  • 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 ICU admission ] [ Designated as safety issue: Yes ]
    mechanical ventilation free days at the first 28 day of admission
  • ICU length of stay [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    ICU length of stay (in days)
Not Provided
Not Provided
 
0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hyponatremia
  • Drug: hypotonic
    0.45% NaCl/5% dextrose IV maintenance fluids
    Other Name: half saline/5% dextrose
  • Drug: isotonic
    0.9% NaCl/5% dextrose IV maintenance fluids
    Other Name: normal saline/5% dextrose
  • Active Comparator: Hypotonic
    Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
    Intervention: Drug: hypotonic
  • Experimental: Isotonic
    Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
    Intervention: Drug: isotonic

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
November 2011
November 2011   (final data collection date for primary outcome measure)

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).
Both
1 Month to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT01301274
HGNPE-20-2011
Yes
Hospital General de Niños Pedro de Elizalde
Hospital General de Niños Pedro de Elizalde
Not Provided
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
Hospital General de Niños Pedro de Elizalde
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP