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| Name | Class |
|---|---|
| Oulu University Hospital | OTHER |
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The main objective of the trial is to evaluate the risk of hypokalemia following administration of a isotonic solution compared to a hypotonic solution in acutely ill hospitalised children, who need intravenous fluid therapy.
The main objective of the trial is to evaluate the risk of hypokalemia (low plasma potassium concentration) following administration of a Plasmalyte Glucos 50 mg/mL solution compared to a 0.45% saline in 5% dextrose solution in acutely ill hospitalised children, who need intravenous fluid therapy. The secondary objective of the trial is to evaluate the risk of hyponatremia (low plasma sodium concentration) and the risk of hypernatremia (high plasma sodium concentration) following administration of isotonic solution compared to hypotonic solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isotonic solution | Experimental | Plasmalyte Glucos 50 mg/mL; total daily fluid requirements are estimated using the Holiday-Segar method plus possible dehydration (according to child's weight loss during acute illness); intravenous fluids are administered using delivery pumps programmed for an hourly infusion rate (mL/hour); intravenous fluids are administered as long as needed during hospitalization, but no longer than seven days after admission. |
|
| Hypotonic solution | Active Comparator | 0.45% saline in 5% dextrose; total daily fluid requirements are estimated using the Holiday-Segar method plus possible dehydration (according to child's weight loss during acute illness); intravenous fluids are administered using delivery pumps programmed for an hourly infusion rate (mL/hour); intravenous fluids are administered as long as needed during hospitalization, but no longer than seven days after admission. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasmalyte Glucos 50 mg/mL | Drug | Solution contains potassium chloride 5 mmol/L and sodium chloride 140 mmol/L. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of children with a clinically significant electrolyte disorder | Plasma potassium concentration<3.5 mmol/L, or hypernatremia >148 mmol/L, or hyponatremia <132 mmol/L | Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of children with hyponatremia | Plasma sodium concentration of lower than 132 mmol/L. | Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days. |
| Proportion of children with hypernatremia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terhi Tapiainen, MD | Oulu University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu University Hospital | Oulu | 90029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33104176 | Derived | Lehtiranta S, Honkila M, Kallio M, Paalanne N, Peltoniemi O, Pokka T, Renko M, Tapiainen T. Risk of Electrolyte Disorders in Acutely Ill Children Receiving Commercially Available Plasmalike Isotonic Fluids: A Randomized Clinical Trial. JAMA Pediatr. 2021 Jan 1;175(1):28-35. doi: 10.1001/jamapediatrics.2020.3383. |
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| ID | Term |
|---|---|
| D007008 | Hypokalemia |
| D007010 | Hyponatremia |
| D006955 | Hypernatremia |
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 0.45% saline in 5% dextrose | Drug | Solution contains potassium chloride 20 mmol/L and sodium chloride 80 mmol/L. |
|
|
Plasma sodium concentration of higher than 148 mmol/L. |
| Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days. |
| Proportion of children with hypokalemia | Potassium < 3.5 mmol/L | 0-7 days from study entry |
| Proportion of children with severe hypokalemia | Hypokalemia defined as concentration of potassium <3.0 mmol/L | 0-7 days from study entry |
| Fluid retention (g) measured by the weight change | Weight (g) at discharge - weight (g) at admission | 0-7 days: Body weight is measured daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days. |
| Concentration of copeptin in plasma samples | Copeptin plasma concentration | 6-24 hours after study entry |
| Concentration of bicarbonate (HCO3) in plasma samples | Plasma concentration of bicarbonate HCO3 | 1-3 days after study entry |
| Acidosis measured by pH in blood gas analysis | pH in the blood gas analysis | 1-3 days after study entry |
| Alkalosis measured by base excess (BE) in blood gas analysis | Base excess in the blood gas analysis | 1-3 days after study entry |
| Duration of intravenous fluid therapy | Hours from study entry to the stop of fluid therapy | From randomization up to seven days. |
| Proportion of children who needed change of the study fluid treatment | Any change of the fluid used in the treatment | From randomization up to seven days. |
| Proportion of children admitted to ICU | Admission to ICU for any reason | From randomization up to seven days. |
| Time to discharge from hospital in hours | Time from study entry to discharge in hours | From randomization up to seven days. |
| Number of deaths | Any death during the study | 0-30 days from study entry |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |