Skip to main content
OpenTrials
Completed

NCT Number: NCT01301274

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General de Niños Pedro de Elizalde

Buenos Aires, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

hypotonic

Drug

0.45% NaCl/5% dextrose IV maintenance fluids

Other names: half saline/5% dextrose

Isotonic

Drug

0.9% NaCl/5% dextrose IV maintenance fluids

Other names: normal saline/5% dextrose

Primary outcomes

  1. Serum Sodium Levels in Both Groups

    Time frame: first 48 hours

    Mean serum sodium level of each group will be compared at baseline and in the first 48 hours of IV fluid infusion

Secondary outcomes

  1. Mortality at 28 Days

    Time frame: 28 days after admission

    Mortality in both groups will be compared 28 days after admission

  2. Mechanical Ventilation Free Days at 28 Day of Admission

    Time frame: first 28 day after starting mechanical ventilation

    mechanical ventilation free days at the first 28 day of starting mechanical ventilation, if the patient died the corresponding value is zero.

  3. ICU Length of Stay

    Time frame: 180 days

    ICU length of stay (in days)

Sponsors and collaborators

Lead sponsor

Hospital General de Niños Pedro de Elizalde

Other

Registry information

Official study 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

Acronym: NaCrICh

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 23, 2011
Registry last updated
Mar 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.