Clinical trial NCT01909336: Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia
Official title: Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyponatremia
Lead sponsor: Instituto Tecnologico y de Estudios Superiores de Monterey
Sponsor class: OTHER
Collaborators: name: Tecnologico de Monterrey
First posted: 2013-07-26
Enrollment: 161
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if isotonic solutions reduce the risk of hospital acquired hyponatremia compared with hypotonic solutions.

Detailed description: Multicenter, Randomized, Controlled clinical trial.

The purpose of this study is to determine if isotonic solutions reduce the risk of hospital acquired hyponatremia compared with hypotonic solutions

This study will include 150 patients in 2 groups according to these type of pathology: group 1: medical conditions which includes respiratory problems (pneumonia, bronchiolitis, acute asthma attack) and acute gastrointestinal problems (bacterial or viral gastroenteritis) and group 2: surgical conditions (pre, peri or postoperative patients will be included). Each group will be randomized to receive 3 types of interventions: 0.3% Saline (hypotonic solution), 0.45% Saline (hypotonic solution) or 0.9% Saline (isotonic solution). In non-dehydrated patients the daily total volume of liquid infused will be determined by the volumetric Holliday- Segar\* formula and the daily total volume will be calculated by adding the maintenance requirements (using the Holliday Segar formula) to the fluid deficit (according to percent of estimated weight\*\*) in dehydrated patients.

The glucose concentrations in the first group will be 3.3%, and in group 2 and 3 will be 5%. The potassium concentration will be 20mEq/L in all groups. Blood samples will be collected before, 8 hours and 24 hours after the start of intravenous fluid, for the analysis of sodium, potassium, glucose, urea and creatinine. The adverse clinical outcomes at 8 and 24 hours of the start of intravenous fluid will also be recorded. The sodium plasma level, the incidence of hyponatremia and the adverse clinical outcomes will be compared.

\*0-10 kilogram (kg): 100ml/kg per day; 10-20 kg: 1000 ml + 50 ml/kg/day over 10 kg; \>20 kg: 1500 ml + 20ml/ kg over 20kg

\*\* In patients under 10 kg correspond to a loss of 5% (50 mL/kg) in mild dehydration and 10% in moderate dehydration. In 10 kg or more: 3% (30 mL/kg) in mild dehydration and 6% (60 mL/kg) in moderate dehydration.

Eligibility criteria: Inclusion Criteria:

* Children between 3 months to 15 years.
* Need for intravenous fluids for 8 hours or more.
* Normal serum sodium at the beginning of the study of the study (135-145 mEQ/L).
* Acute respiratory problems (acute asthma attack, bronchiolitis or pneumonia).
* Acute gastrointestinal disorders (viral o bacterial gastroenteritis).
* Elective surgical procedures.
* Pre, peri o post operative patients (acute appendicitis, intussusception, intestinal perforation, ileus).

Exclusion Criteria:

* Severe hyponatremia (serum sodium \< 125 mEq/L).
* Severe hypernatremia (serum sodium \>155 mEq/L).
* Need for intravenous fluids for less than 8 hours according with their treating physician.
* Severe dehydration or Shock.
* Preexisting chronic diseases (renal diseases, heart diseases or endocrine disorders).
* Neurologic diseases.
* Head trauma.
* Cerebral edema or Intracranial hypertension.
* Diabetic ketoacidosis.
* Use of diuretics one week or less before the study.
* Need for admission to the pediatric critical intensive care unit

Primary outcomes:
measure: Hospital Acquired Hyponatremia
timeFrame: 8 hours
Secondary outcomes:
measure: Dysnatraemias at T8
timeFrame: 8 hours
measure: Adverse Reactions Attributed to Acute Plasma Sodium Changes
timeFrame: 8 hours
Other outcomes:
Locations:
Study officials:
affiliation: Tecnologico de Monterrey
name: Claudia Montserrat Flores Robles, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Medicina Basada en Evidencias, Escuela de Medicina y Ciencias de la Salud, Tecnológico de Monterrey.
name: Carlos Alberto Cuello García, MD
role: STUDY_DIRECTOR
References:
citation: Moritz ML, Ayus JC. Hospital-acquired hyponatremia--why are hypotonic parenteral fluids still being used? Nat Clin Pract Nephrol. 2007 Jul;3(7):374-82. doi: 10.1038/ncpneph0526.
citation: 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.
citation: Montanana PA, Modesto i Alapont V, Ocon AP, Lopez PO, Lopez Prats JL, Toledo Parreno JD. The use of isotonic fluid as maintenance therapy prevents iatrogenic hyponatremia in pediatrics: a randomized, controlled open study. Pediatr Crit Care Med. 2008 Nov;9(6):589-97. doi: 10.1097/PCC.0b013e31818d3192.