Hyponatremia
Conditions
Keywords
hyponatremia, maintenance solutions, pediatrics
Brief summary
The primary objective of this study is to compare the mean serum sodium after 48 hours of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in critically ill children requiring IV maintenance fluid administration.
Detailed description
In patients without possibilities of oral intake, maintenance fluids provide electrolytes and water. Since the original descriptions by Holliday and Segar, the recommended standard maintenance solutions are based on physiological needs, containing 30-50 mEq/L of sodium. However hyponatremia has become increasingly recognized in hospitalized children suggesting that Holliday and Segar's recommendations are frequently inappropriately applied. It has been described augmented intersticial lung water in patients receiving hypotonic maintenance solutions. Also, hyponatremia has been demonstrated in post-surgery critically ill children receiving hypotonic maintenance solutions. More over, non-physiologic antidiuretic hormone (ADH) secretion has been described in the great majority of hospitalized children due to nausea, stress, pain, and/or surgical interventions. It has been suggested that isotonic 0.9% NaCl/dextrose 5% should be the standard maintenance intravenous (IV) solution, to avoid the development of hyponatremia. There are not studies in critically ill children evaluating the effect of isotonic solutions on sodium levels.
Interventions
Sponsors
Hospital General de Niños Pedro de Elizalde
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age 1 month to 18 years * ICU stay \>24 hours * Normal seric sodium (135 - 145 mEq/L). * Requirement of IV maintenance solutions \>80% total fluids intake
Exclusion criteria
* Patients with diagnoses of renal failure (serum creatinine \>1 g/dl in \<3 years old children, \>1,5 in \>3 years), hepatic failure with ascitis and portal hypertension, adrenal failure, nephrotic - nephritic syndrome, Kawasaki disease, sickle cell anemia, Syndrome of inappropriate antidiuretic hormone secretion, diabetes insipidus,metabolic disease. * Diuretics use in the first 48 hours thereafter indicated IV solutions. * Plasma glucose is \>200 mg%. * Any patients requiring IV fluids therapy different that maintenance (total parenteral nutrition, hyperhydration).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Sodium Levels in Both Groups | first 48 hours | Mean serum sodium level of each group will be compared at baseline and in the first 48 hours of IV fluid infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality at 28 Days | 28 days after admission | Mortality in both groups will be compared 28 days after admission |
| Mechanical Ventilation Free Days at 28 Day of Admission | first 28 day after starting mechanical ventilation | mechanical ventilation free days at the first 28 day of starting mechanical ventilation, if the patient died the corresponding value is zero. |
| ICU Length of Stay | 180 days | ICU length of stay (in days) |
Countries
Argentina
Participant flow
Recruitment details
Intensive Care Unit without cardiovascular patients, since 01/02/2011 until 01/11/2011
Pre-assignment details
251 admitted patients to ICU, 97 eligible patients, 9 patients did not give consent, 22 were not randomized by treatment physician
Participants by arm
| Arm | Count |
|---|---|
| Hypotonic Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids. | 34 |
| Isotonic Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids. | 32 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 2 | 1 |
Baseline characteristics
| Characteristic | Isotonic | Hypotonic | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 32 Participants | 34 Participants | 66 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 1.2 years STANDARD_DEVIATION 3.2 | 3 years STANDARD_DEVIATION 4.7 | 2.2 years STANDARD_DEVIATION 4.1 |
| Region of Enrollment Argentina | 32 participants | 34 participants | 66 participants |
| Sex: Female, Male Female | 12 Participants | 14 Participants | 26 Participants |
| Sex: Female, Male Male | 20 Participants | 20 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 34 | 4 / 32 |
| serious Total, serious adverse events | 4 / 34 | 0 / 32 |
Outcome results
Primary
Serum Sodium Levels in Both Groups
Mean serum sodium level of each group will be compared at baseline and in the first 48 hours of IV fluid infusion
Time frame: first 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypotonic Arm | Serum Sodium Levels in Both Groups | 137.8 mEq/L | Standard Deviation 4.3 |
| Isotonic Arm | Serum Sodium Levels in Both Groups | 140.0 mEq/L | Standard Deviation 4.1 |
p-value: 0.04t-test, 2 sided
Secondary
ICU Length of Stay
ICU length of stay (in days)
Time frame: 180 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypotonic Arm | ICU Length of Stay | 8.5 days | Standard Deviation 5.5 |
| Isotonic Arm | ICU Length of Stay | 11.9 days | Standard Deviation 11.5 |
p-value: 0.129t-test, 2 sided
Secondary
Mechanical Ventilation Free Days at 28 Day of Admission
mechanical ventilation free days at the first 28 day of starting mechanical ventilation, if the patient died the corresponding value is zero.
Time frame: first 28 day after starting mechanical ventilation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypotonic Arm | Mechanical Ventilation Free Days at 28 Day of Admission | 19.9 days | Standard Deviation 7.9 |
| Isotonic Arm | Mechanical Ventilation Free Days at 28 Day of Admission | 21.5 days | Standard Deviation 6.6 |
p-value: 0.396t-test, 2 sided
Secondary
Mortality at 28 Days
Mortality in both groups will be compared 28 days after admission
Time frame: 28 days after admission
Population: The analysis was per intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hypotonic Arm | Mortality at 28 Days | 3 participants |
| Isotonic Arm | Mortality at 28 Days | 0 participants |
p-value: 0.081Chi-squared