Status:
COMPLETED
Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia
Lead Sponsor:
Instituto Tecnologico y de Estudios Superiores de Monterey
Collaborating Sponsors:
Tecnologico de Monterrey
Conditions:
Hyponatremia
Eligibility:
All Genders
3-15 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT01909336
Start Date
July 1 2013
End Date
April 1 2014
Last Update
December 16 2016
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