Burn Any Degree Involving 20-29 Percent of Body Surface, Burn Any Degree Involving 30-39 Percent of Body Surface, Burn Any Degree Involving 40-49 Percent of Body Surface, Burn Any Degree Involving 50-59 Percent of Body Surface, Burn Any Degree Involving 60-65 Percent of Body Surface, Fluid Resuscitation
Conditions
Keywords
Oral Rehydration Therapy
Brief summary
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.
Detailed description
Primary objectives * To show that ORT in burns (using Ceralyte® 90) can reduce the total amount of intravenous fluid needed for adequate resuscitation. * To test the efficacy and safety of ORT in resuscitation of burn patients Secondary objectives. * To encourage further research on the use of ORT in large thermal injuries and mass casualty situations.
Interventions
DRUGCeraLyte 90
1. This is a prospective pilot study of patients with moderate-major burn wounds (20-65% TBSA). 2. Patients who meet inclusion/exclusion criteria will be enrolled in the study upon admission to the Burn Unit. 3. Fluid requirements will be calculated according to the Parkland Formula (4 cc/kg/% Total Body Surface Area) administered over 24 hours since time of injury. 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.
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients aged 18-65 years * Partial- to full-thickness burn injuries involving 20-65% of total body surface area (TBSA)
Exclusion criteria
* Presence of inhalation injury * Hypotension or shock * Concomitant serious traumatic injury (i.e. head/ spine trauma) * Gastric Bypass Surgery * Small Bowel Obstruction * Delay in resuscitation \>2 hrs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a 20% Decrease in Required IV Fluid. | 24 hours post-burn | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Oral Rehydration Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 50.7 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 3 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 3 / 3 |
| serious Total, serious adverse events | 1 / 3 |
Outcome results
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
Time frame: 24 hours post-burn
Population: All participants who received the treatment (Ceralyte 90)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Rehydration Therapy | Number of Participants With a 20% Decrease in Required IV Fluid. | 0 participants |