Clinical trial NCT02124265: Oral Rehydration Therapy in Burn Patients
Official title: Oral Rehydration Therapy in Burn Patients Phase 1
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: 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
Keywords: Oral Rehydration Therapy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With a 20% Decrease in Required IV Fluid.
timeFrame: 24 hours post-burn
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Burn Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Stephen M Milner, MBBS
role: PRINCIPAL_INVESTIGATOR
References: