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Intervention appeared to be associated with increased nausea in some patients.
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In patients with moderate to severe thermal injuries (> 20% TBSA) adequate fluid resuscitation is the main priority to achieve successful outcomes. Soon after burn injury substantial amounts of fluid accumulate rapidly in the wound while more is lost in the third space. Without intervention this process leads to hypotension and shock. The Parkland formula was devised to calculate how much intravenous (IV) fluid, i.e. crystalloids, is needed for adequate resuscitation during the first 24 hours post-burn. However, IV resuscitation can lead to overexpansion of (third space) volume, leading to severe complications such as compartment syndrome or pulmonary edema.
In major population centers, catastrophic events causing mass casualties will disrupt many hospital and emergency services, potentially delaying acute IV fluid resuscitation. Burn patient case reports have shown that oral rehydration therapy (ORT) used to supplement or in place of IV therapy is efficacious. ORT could be easily applied in mass burn casualties.
ORT is generally known in the third world for treating life-threatening dehydration due to diarrhea. The glucose-sodium co transport mechanism enables the affected human intestine to absorb a sufficient amount of water and electrolytes to replace large fluid losses due to severe diarrhea, even under adverse field conditions. No electrolyte disturbances have been recorded in such cases. Studies on enteral resuscitation in animal burn models showed high rates of small intestinal absorption which should be adequate for resuscitation following major burn injury.
The optimal composition of oral rehydration solution for resuscitation in burn wounds has not been determined. In cholera patients, Ceralyte® has proven superior to the World Health Organization Oral Rehydration Solution, increasing fluid absorption of the intestine. The Ceralyte® 90 solution, with 90mEq/L sodium and a low osmolarity of <275mOsm, may also contribute to optimal intestinal fluid uptake without causing electrolyte disturbances in thermal injury. ORT use might reduce the occurrence of compartment syndrome and pulmonary edema since fluid is regulated by the intestine according to physiologic requirements. The investigators propose to conduct a prospective study using Ceralyte® 90 to show that oral resuscitation therapy (ORT) in burns can reduce the total amount of IV fluid needed for adequate resuscitation and to test the efficacy and safety of ORT in the resuscitation of burn patients.
Primary objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceralyte 90 | Experimental | Ceralyte® will be administered during the first 24-hours post-burn. Fluid requirements will be calculated according to the Parkland Formula with 50% administered during the first 8 hours and the second 50% administered over the next 16 hours. During the first 2 hours IV fluids will be started at the Parkland goal minus 250cc, which will be administered using Ceralyte via oral, nasogastric (NG), or dobhoff tube. ORT and IV fluids will be monitored with additional doses given hourly. Urine output will be monitored hourly and gastric residuals will be monitored every 2 hours, with adjustments made as needed to ensure adequate fluid resuscitation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CeraLyte 90 | Drug |
5. Patients will be monitored according to standard of care. a. If gastric residuals are >300cc, ORT will be stopped and only IV fluid resuscitation will be used. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a 20% Decrease in Required IV Fluid. | Number of participants whose IV fluids were reduced to less than or equal to 80% of the Parkland Goal IV resuscitation formula within the first 24 hours of initial burn injury. To test the efficacy and safety of Oral RehydrationTherapy in resuscitation of burn patients | 24 hours post-burn |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen M Milner, MBBS | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Burn Center | Baltimore | Maryland | 21224 | United States |
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| Label | URL |
|---|---|
| Oral Rehydration | View source |
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Only 3 patients were enrolled. No statistical analyses were performed.
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Participants aged 18-65 years with 20-65% of total body surface area (TBSA) partial- to full-thickness burns were recruited from the burn unit from May 2013 through May 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Rehydration Therapy | Ceralyte 90® was administered during first 24-hours post-burn. Fluid requirements were calculated according to Parkland Formula: 50% administered during first 8 hours, 50% administered over next 16 hours. During first 2 hours IV fluids were started at Parkland goal minus 250cc, which was administered using Ceralyte via oral, nasogastric, or dobhoff tube. ORT and IV fluids were monitored with additional doses given hourly. Urine output was monitored hourly and gastric residuals were monitored every 2 hours, with adjustments made as needed to ensure adequate fluid resuscitation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Rehydration Therapy | Ceralyte 90® was administered during first 24-hours post-burn. Fluid requirements were calculated according to Parkland Formula: 50% administered during first 8 hours, 50% administered over next 16 hours. During first 2 hours IV fluids were started at Parkland goal minus 250cc, which was administered using Ceralyte via oral, NG, or dobhoff tube. ORT and IV fluids were monitored with additional doses given hourly. Urine output was monitored hourly and gastric residuals were monitored every 2 hours, with adjustments made as needed to ensure adequate fluid resuscitation. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Number of Participants With a 20% Decrease in Required IV Fluid. | Number of participants whose IV fluids were reduced to less than or equal to 80% of the Parkland Goal IV resuscitation formula within the first 24 hours of initial burn injury. To test the efficacy and safety of Oral RehydrationTherapy in resuscitation of burn patients | All participants who received the treatment (Ceralyte 90) | Posted | Number | participants | 24 hours post-burn |
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24 hours
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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 | Oral Rehydration Therapy | Ceralyte 90® was administered during first 24-hours post-burn. Fluid requirements were calculated according to Parkland Formula: 50% administered during first 8 hours, 50% administered over next 16 hours. During first 2 hours IV fluids were started at Parkland goal minus 250cc, which was administered using Ceralyte via oral, NG, or dobhoff tube. ORT and IV fluids were monitored with additional doses given hourly. Urine output was monitored hourly and gastric residuals were monitored every 2 hours, with adjustments made as needed to ensure adequate fluid resuscitation. | 0 | 3 | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Residuals | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Anuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carisa Cooney | Johns Hopkins University School of Medicine | 443-287-4629 | ccooney3@jhmi.edu |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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