Trial Outcomes & Findings for Oral Rehydration Therapy in Burn Patients (NCT NCT02124265)

Last Updated: 2019-02-18

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

3 participants

Primary outcome timeframe

24 hours post-burn

Results posted on

2019-02-18

Participant Flow

Participants aged 18-65 years with 20-65% of total body surface area (TBSA) partial- to full-thickness burns were recruited from the burn unit from May 2013 through May 2015.

Participant milestones

Participant milestones
Measure	Oral Rehydration Therapy Ceralyte 90® was administered during first 24-hours post-burn. Fluid requirements were calculated according to Parkland Formula: 50% administered during first 8 hours, 50% administered over next 16 hours. During first 2 hours IV fluids were started at Parkland goal minus 250cc, which was administered using Ceralyte via oral, nasogastric, or dobhoff tube. ORT and IV fluids were monitored with additional doses given hourly. Urine output was monitored hourly and gastric residuals were monitored every 2 hours, with adjustments made as needed to ensure adequate fluid resuscitation.
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Oral Rehydration Therapy Ceralyte 90® was administered during first 24-hours post-burn. Fluid requirements were calculated according to Parkland Formula: 50% administered during first 8 hours, 50% administered over next 16 hours. During first 2 hours IV fluids were started at Parkland goal minus 250cc, which was administered using Ceralyte via oral, nasogastric, or dobhoff tube. ORT and IV fluids were monitored with additional doses given hourly. Urine output was monitored hourly and gastric residuals were monitored every 2 hours, with adjustments made as needed to ensure adequate fluid resuscitation.
Overall Study Adverse Event	1

Baseline Characteristics

Oral Rehydration Therapy in Burn Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Rehydration Therapy n=3 Participants Ceralyte 90® was administered during first 24-hours post-burn. Fluid requirements were calculated according to Parkland Formula: 50% administered during first 8 hours, 50% administered over next 16 hours. During first 2 hours IV fluids were started at Parkland goal minus 250cc, which was administered using Ceralyte via oral, NG, or dobhoff tube. ORT and IV fluids were monitored with additional doses given hourly. Urine output was monitored hourly and gastric residuals were monitored every 2 hours, with adjustments made as needed to ensure adequate fluid resuscitation.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	50.7 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours post-burn

Population: All participants who received the treatment (Ceralyte 90)

Outcome measures

Outcome measures
Measure	Oral Rehydration Therapy n=3 Participants Ceralyte 90® was administered during first 24-hours post-burn. Fluid requirements were calculated according to Parkland Formula: 50% administered during first 8 hours, 50% administered over next 16 hours. During first 2 hours IV fluids were started at Parkland goal minus 250cc, which was administered using Ceralyte via oral, NG, or dobhoff tube. ORT and IV fluids were monitored with additional doses given hourly. Urine output was monitored hourly and gastric residuals were monitored every 2 hours, with adjustments made as needed to ensure adequate fluid resuscitation.
Number of Participants With a 20% Decrease in Required IV Fluid.	0 participants

Adverse Events

Oral Rehydration Therapy

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oral Rehydration Therapy n=3 participants at risk Ceralyte 90® was administered during first 24-hours post-burn. Fluid requirements were calculated according to Parkland Formula: 50% administered during first 8 hours, 50% administered over next 16 hours. During first 2 hours IV fluids were started at Parkland goal minus 250cc, which was administered using Ceralyte via oral, NG, or dobhoff tube. ORT and IV fluids were monitored with additional doses given hourly. Urine output was monitored hourly and gastric residuals were monitored every 2 hours, with adjustments made as needed to ensure adequate fluid resuscitation.
Renal and urinary disorders Anuria	33.3% 1/3 • Number of events 3 • 24 hours

Other adverse events

Other adverse events
Measure	Oral Rehydration Therapy n=3 participants at risk Ceralyte 90® was administered during first 24-hours post-burn. Fluid requirements were calculated according to Parkland Formula: 50% administered during first 8 hours, 50% administered over next 16 hours. During first 2 hours IV fluids were started at Parkland goal minus 250cc, which was administered using Ceralyte via oral, NG, or dobhoff tube. ORT and IV fluids were monitored with additional doses given hourly. Urine output was monitored hourly and gastric residuals were monitored every 2 hours, with adjustments made as needed to ensure adequate fluid resuscitation.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 2 • 24 hours
Gastrointestinal disorders Residuals	66.7% 2/3 • Number of events 7 • 24 hours
Renal and urinary disorders Anuria	66.7% 2/3 • Number of events 5 • 24 hours

Additional Information

Carisa Cooney

Johns Hopkins University School of Medicine

Phone: 443-287-4629

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place