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| Name | Class |
|---|---|
| The Physicians' Services Incorporated Foundation | OTHER |
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This study will look at children with dehydration secondary to gastroenteritis requiring IV rehydration and determine whether the proportion rehydrated after two hours is greater in the children who receive rapid intravenous rehydration (RIVR) or in the children who receive standard IV rehydration.
Despite a movement toward increased use of enteral rehydration, many children still receive prolonged IV rehydration in the emergency department (ED). These children commonly receive a single IV bolus of normal saline followed by the administration of a hypotonic solution at a maintenance rate.
The mean time spent in the ED by children receiving IV rehydration is significantly longer than the mean time required to treat all other conditions. ED overcrowding has been associated with poor outcomes, prolonged pain and suffering, and dissatisfaction. One of the solutions proposed in the American Academy of Pediatrics Policy Statement on ED overcrowding is that hospitals should strive to improve the efficiency of the care provided. One small step in this direction may be to improve our management of gastroenteritis and dehydration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard IV rehydration | Drug | A 20 mL/kg 0.9% normal saline bolus (maximum 999 mL) will be administered over 1 hour. This will be followed by D5-0.9% normal saline at a maintenance rate (maximum 55 mL/hr). |
| Measure | Description | Time Frame |
|---|---|---|
| Rehydration criteria defined by: dehydration score ≤ 1, normal capillary refill time, normal skin turgor, normal respiratory rate | 2 hours following the initiation of IV rehydration |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization | 72 hours | |
| Ability to tolerate oral rehydration | Measured per 2 hour time period after consuming 5 mL/kg of liquid | |
| Repeat ED visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen B Freedman, MD | The Hospital for Sick Children, Toronto Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23993936 | Derived | Freedman SB, DeGroot JM, Parkin PC. Successful discharge of children with gastroenteritis requiring intravenous rehydration. J Emerg Med. 2014 Jan;46(1):9-20. doi: 10.1016/j.jemermed.2013.04.044. Epub 2013 Aug 30. | |
| 22094316 | Derived | Freedman SB, Parkin PC, Willan AR, Schuh S. Rapid versus standard intravenous rehydration in paediatric gastroenteritis: pragmatic blinded randomised clinical trial. BMJ. 2011 Nov 17;343:d6976. doi: 10.1136/bmj.d6976. |
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| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
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| Rapid intravenous rehydration (RIVR) | Drug | A 60 mL/kg 0.9% normal saline bolus (maximum 999 mL) over 1 hour will be administered. This will be followed by D5-0.9% normal saline at a maintenance rate (maximum 55 mL/hr). |
|
| 72 hours |
| Time (in minutes) from initiation of IV rehydration until disposition determination | Determined by outcome |
| Attending physician discharge comfort level | Two and four hours following initiation of IV rehydration |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |