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NCT02124265 · ClinicalTrials.gov registry record · Phase 1
Oral Rehydration Therapy in Burn Patients
A Phase 1 study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT02124265: Clinical Trial Phase 1 study, sponsored by Johns Hopkins University.
NCT02124265 is a Phase 1 study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02124265, a Phase 1 study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study 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 upta
Interventions
- DRUG CeraLyte 90
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2013-05 |
| Est. Completion | 2015-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02124265
The ClinicalTrials.gov registry entry for NCT02124265 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CeraLyte 90 is the first listed.
NCT02124265 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02124265 about?
NCT02124265 is a clinical study titled "Oral Rehydration Therapy in Burn Patients". 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 pr...
What is the current status of trial NCT02124265?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2013-05. Estimated completion is 2015-03.
What interventions are being tested in trial NCT02124265?
The interventions under investigation include: CeraLyte 90 (DRUG).
Who is sponsoring clinical trial NCT02124265?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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