Clinical Trial: Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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

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



Original Primary Outcome:

  • Hospital Acquired Hyponatremia [ Time Frame: 8 hours ]
    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
  • Hospital acquired hyponatremia [ Time Frame: 24 hours ]
    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


Current Secondary Outcome:

  • Dysnatraemias at T8 [ Time Frame: 8 hours ]
    hyponatraemia (defined as serum sodium < 135 mmol/L), normonatremia (defined as serum sodium 135-145 mmol/L) or hypernatraemia (defined as serum sodium > 145 mmol/L)
  • Adverse Reactions Attributed to Acute Plasma Sodium Changes [ Time Frame: 8 hours ]
    Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes assessed at 8 hours


Original Secondary Outcome:

  • change in serum sodium [ Time Frame: baseline to 8 hours ]
    rate of change in serum sodium from baseline to 8 hours
  • change in serum sodium [ Time Frame: Baseline to 24 hours ]
    change in serum sodium from baseline to 24 hours
  • Adverse Reactions Attributed to Acute Plasma Sodium Changes [ Time Frame: 24 hours ]
    Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes assessed at 24 hours


Information By: Instituto Tecnologico y de Estudios Superiores de Monterey

Dates:
Date Received: July 14, 2013
Date Started: July 2013
Date Completion:
Last Updated: October 21, 2016
Last Verified: October 2016