Fluid Resuscitation Clinical Trial
Official title:
Oral Rehydration Therapy in Burn Patients Phase 1
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
- 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.
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