Oral Rehydration Therapy in Burn Patients
Condition: 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
MeSH terms: Burns
Intervention: CeraLyte 90
Intervention description: This is a prospective pilot study of patients with moderate-major burn wounds (20-65% TBSA).
Patients who meet inclusion/exclusion criteria will be enrolled in the study upon admission to the Burn Unit.
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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Oral Rehydration Therapy

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.
    

Eligibility criteria:

        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.