Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia

Hyponatremia Clinical Trial

Official title:

Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909336
• Other study ID #: SIvsSHnh
• Status: Completed
• Phase: Phase 3
• First received: July 14, 2013
• Last updated: April 2, 2015
• Start date: July 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2015
• Source: Instituto Tecnologico y de Estudios Superiores de Monterey
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics CommitteeMexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyponatremia

Intervention

Drug:
• 0.3% Saline in 3.3% dextrose
Hypotonic Solutions: 0.3% Saline in 3.3% dextrose
• 0.45% Saline in 5% dextrose
Hypotonic Solutions: 0.45% Saline in 5% dextrose
• 0.9% Saline in 5% dextrose
Isotonic Solutions 0.9% Saline in 5% dextrose

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Tecnologico y de Estudios Superiores de Monterey	Tecnologico de Monterrey

References & Publications (3)

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. Epub 2006 Jun 5. Review. — View Citation

Montañana PA, Modesto i Alapont V, Ocón AP, López PO, López Prats JL, Toledo Parreño 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital acquired hyponatremia	Serum sodium less than 135 mEq/L at 8 hours in a patient with normal serum sodium (135 mEq/L to 145mEq/L) at the beginning of the study	8 hours	Yes
Primary	Hospital acquired hyponatremia	Serum sodium less than 135 mEq/L at 24 hours in a patient with normal serum sodium (135 mEq/L to 145mEq/L) at the beginning of the study	24 hours	Yes
Secondary	change in serum sodium	rate of change in serum sodium from baseline to 8 hours	baseline to 8 hours	Yes
Secondary	change in serum sodium	change in serum sodium from baseline to 24 hours	Baseline to 24 hours	Yes
Secondary	Adverse Reactions attributed to Acute Plasma Sodium Changes	Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes assessed at 24 hours	24 hours	Yes