Burn Any Degree Involving 20-29 Percent of Body SurfacePhase 1ORTNCT02124265
Oral Rehydration Therapy in Burn Patients
A Phase 1 study testing CeraLyte 90 in people with Burn Any Degree Involving 20-29 Percent of Body Surface and Burn Any Degree Involving 30-39 Percent of Body Surface, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- 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
- What is being tested?
- CeraLyte 90
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Mar 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18-65 years
- Partial- to full-thickness burn injuries involving 20-65% of total body surface area (TBSA)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Burn Center
Baltimore, Maryland, 21224
About this study
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.
Read more
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.
Read the 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.
- 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
- Being tested
- CeraLyte 90
- Keywords
- Oral Rehydration Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeraLyte 90Drug
- 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.
- Patients will be monitored according to standard of care.
- If gastric residuals are >300cc, ORT will be stopped and only IV fluid resuscitation will be used.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CeraLyte 90 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours post-burn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startMay 2013
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Intervention appeared to be associated with increased nausea in some patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Burn Any Degree Involving 20-29 Percent of Body SurfaceStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen M Milner, MBBS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124265
- Sponsor's protocol ID
- 00038778
- Acronym
- ORT
- Status last verified
- Feb 2019
- First submitted
- 13 Aug 2013
- Last updated
- 18 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Only 3 patients were enrolled. No statistical analyses were performed.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Rehydration Therapy in Burn Patients Phase 1
- ClinicalTrials.gov ID
- NCT02124265
- Acronym / sponsor ID
- ORT / 00038778
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Intervention appeared to be associated with increased nausea in some patients.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Posted 18 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ceralyte 90 | Experimental | Drug: CeraLyte 90Ceralyte® 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients aged 18-65 years
- Partial- to full-thickness burn injuries involving 20-65% of total body surface area (TBSA)
Key exclusion criteria (6 listed)
- Presence of inhalation injury
- Hypotension or shock
- Concomitant serious traumatic injury (i.e. head/ spine trauma)
- Gastric Bypass Surgery
- Small Bowel Obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeraLyte 901. 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. | Drug | Ceralyte 90 |
Primary outcome
Number of Participants With a 20% Decrease in Required IV Fluid.
Time frame: 24 hours post-burn
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Oral RehydrationLink provided by the sponsor.
- Individual participant dataSharing planned: No. Only 3 patients were enrolled. No statistical analyses were performed.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen M Milner, MBBS principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CeraLyte 90 in people with Burn Any Degree Involving 20-29 Percent of Body Surface and Burn Any Degree Involving 30-39 Percent of Body Surface, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a 20% Decrease in Required IV Fluid. (time frame: 24 hours post-burn). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.