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Oral Rehydration Therapy in Burn Patients (ORT)

Primary Purpose

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

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CeraLyte 90
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn Any Degree Involving 20-29 Percent of Body Surface focused on measuring Oral Rehydration Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Bayview Burn Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ceralyte 90

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 13, 2013
Last Updated
February 11, 2019
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT02124265
Brief Title
Oral Rehydration Therapy in Burn Patients
Acronym
ORT
Official Title
Oral Rehydration Therapy in Burn Patients Phase 1
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Intervention appeared to be associated with increased nausea in some patients.
Study Start Date
May 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ceralyte 90
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
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.
Primary Outcome Measure Information:
Title
Number of Participants With a 20% Decrease in Required IV Fluid.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen M Milner, MBBS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Burn Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only 3 patients were enrolled. No statistical analyses were performed.
Links:
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2933130/
Description
Oral Rehydration

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Oral Rehydration Therapy in Burn Patients

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