Oral Rehydration Therapy in Burn Patients

NCT02124265 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: 00038778
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Drug: CeraLyte 90

Interventions

CeraLyte 90 DRUG

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.

Ceralyte 90

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18-65 years
• Partial- to full-thickness burn injuries involving 20-65% of total body surface area (TBSA)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Burn Center

Baltimore, Maryland, 21224, United States

Location

Related Links

• Oral Rehydration

Results Point of Contact

• Title: Carisa Cooney
• Organization: Johns Hopkins University School of Medicine

ccooney3@jhmi.edu

443-287-4629

Study Officials

• Stephen M Milner, MBBS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: April 28, 2014
• Study Start: May 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: February 18, 2019
• Results First Posted: February 18, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)