Fluid Resuscitation Clinical Trial
— ORTOfficial title:
Oral Rehydration Therapy in Burn Patients Phase 1
NCT number | NCT02124265 |
Other study ID # | 00038778 |
Secondary ID | |
Status | Terminated |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | May 2013 |
Est. completion date | March 2015 |
Verified date | February 2019 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Bayview Burn Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01494116 -
Pediatric Fast Fluid Randomized Controlled Trial
|
N/A | |
Not yet recruiting |
NCT05453565 -
Restricted or Liberal Fluid for Haemodynamic Resuscitation in Sepsis
|
||
Not yet recruiting |
NCT04449757 -
Bicarbonated Ringer's Solution Versus Lactated Ringer's Solution in Patients With Septic Shock
|
N/A | |
Completed |
NCT03118362 -
Fluid Resuscitation in Burn Patients
|
Phase 3 | |
Not yet recruiting |
NCT06370975 -
Effect of Fluid Resuscitation on Lactate in Traumatic Injury Patients
|
Phase 1/Phase 2 | |
Completed |
NCT02656654 -
COrporeal Compression at the ONset of Severe Sepsis and Septic Shock
|
N/A | |
Completed |
NCT06075407 -
Evaluation of Fluid Resuscitation in Shocked Patients by Electrical Cardiometry in Comparison to Transthoracic Echocardiography.
|