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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypotonic | Active Comparator | Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids. |
|
| Isotonic | Experimental | Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypotonic | Drug | 0.45% NaCl/5% dextrose IV maintenance fluids |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | first 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at 28 Days | Mortality in both groups will be compared 28 days after admission | 28 days after admission |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Facundo A Jorro, MD | Hospital General de Niños Pedro de Elizalde | Principal Investigator |
| Gustavo De Baisi, MD | Hospital General de Niños Pedro de Elizalde | Study Director |
| Susana Bengoa | Hospital General de Niños Pedro de Elizalde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Niños Pedro de Elizalde | Buenos Aires | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 13465804 | Background | HOLLIDAY MA, SEGAR WE, LUKENBILL A, VALENCIA RM, DURELL AM. Variations in muscle electrolyte composition due to sampling and to aging. Proc Soc Exp Biol Med. 1957 Aug-Sep;95(4):786-8. doi: 10.3181/00379727-95-23364. No abstract available. | |
| 6861500 | Background | Burrows FA, Shutack JG, Crone RK. Inappropriate secretion of antidiuretic hormone in a postsurgical pediatric population. Crit Care Med. 1983 Jul;11(7):527-31. doi: 10.1097/00003246-198307000-00009. |
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251 admitted patients to ICU, 97 eligible patients, 9 patients did not give consent, 22 were not randomized by treatment physician
Intensive Care Unit without cardiovascular patients, since 01/02/2011 until 01/11/2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypotonic | Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids. |
| FG001 | Isotonic | Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypotonic | Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids. |
| BG001 | Isotonic | Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | mEq/L | first 48 hours |
|
|
until they were receiving the maintenance solution, mean time 24 hours up to 48 hours. The adverse events were collected up to PICU discharged, mean time 7.4 days, except mortality up to 28 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hypotonic | Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hyponatremia <130 mEq/l | General disorders | Severe hyponatremia | Non-systematic Assessment | serum sodium <130 mEq/l, without symptoms. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serum sodium < 135 mEq/l | General disorders | Hyponatremia | Non-systematic Assessment | serum sodium between 130 - 134,9 mEq/l, without neurological symptoms. |
Limitations: Antidiuretic hormone were not measured.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Facundo Jorro Barón | Intensive Care Unit - Hospital Pedro de Elizalde | 00541143632100 | 2035 | jorrobox@yahoo.com.ar |
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| ID | Term |
|---|---|
| D007010 | Hyponatremia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| isotonic | Drug | 0.9% NaCl/5% dextrose IV maintenance fluids |
|
|
| first 28 day after starting mechanical ventilation |
| ICU Length of Stay | ICU length of stay (in days) | 180 days |
| 20124948 | Background | Eulmesekian PG, Perez A, Minces PG, Bohn D. Hospital-acquired hyponatremia in postoperative pediatric patients: prospective observational study. Pediatr Crit Care Med. 2010 Jul;11(4):479-83. doi: 10.1097/PCC.0b013e3181ce7154. |
| 16754657 | Background | 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. doi: 10.1136/adc.2005.088690. Epub 2006 Jun 5. |
| 23912284 | Derived | Jorro Baron FA, Meregalli CN, Rombola VA, Bolasell C, Pigliapoco VE, Bartoletti SE, Debaisi GE. Hypotonic versus isotonic maintenance fluids in critically ill pediatric patients: a randomized controlled trial. Arch Argent Pediatr. 2013 Jul-Aug;111(4):281-7. doi: 10.5546/aap.2013.eng.281. English, Spanish. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
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| Secondary | Mortality at 28 Days | Mortality in both groups will be compared 28 days after admission | The analysis was per intention to treat | Posted | Number | participants | 28 days after admission |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | days | first 28 day after starting mechanical ventilation |
|
|
|
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| Secondary | ICU Length of Stay | ICU length of stay (in days) | Posted | Mean | Standard Deviation | days | 180 days |
|
|
|
|
| 4 |
| 34 |
| 5 |
| 34 |
| EG001 | Isotonic | Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids. | 0 | 32 | 4 | 32 |
|
| Death | General disorders | Systematic Assessment | patient death that occurred between up to 28 days after randomization. |
|
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