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Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia.
The purpose of this study is to determine if isotonic solutions reduce the risk of hospital acquired hyponatremia compared with hypotonic solutions.
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.
Age
0 - 15 years
Sex
ALL
Healthy Volunteers
Yes
Start Date
July 1, 2013
Primary Completion Date
February 1, 2014
Completion Date
April 1, 2014
Last Updated
December 16, 2016
161
ACTUAL participants
0.3% Saline in 3.3% dextrose
DRUG
0.45% Saline in 5% dextrose
DRUG
0.9% Saline in 5% dextrose
DRUG
Lead Sponsor
Instituto Tecnologico y de Estudios Superiores de Monterey
Collaborators
NCT06408077
NCT07255833
NCT03557957
Data Source & Attribution
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