ABRuPT2
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StatusAccepting Candidates
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Age18 Years - N/A
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SexesAll
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Healthy VolunteersNo
Objective
This is a prospective randomized multi-center study which will compare acute fluid resuscitation using a colloid strategy (LR + 5% Albumin) to a crystalloid strategy (LR alone), in adults with an acute burn involving at least 25% of their total body surface area.
Description
Enrolled subjects will be randomly assigned to either the Colloid Group or the Crystalloid Group. Randomization will be based on an intent-to-treat basis. In order to ensure that the two groups have comparable injury severity at baseline, randomization will be block* stratified based on age (18-50 and > 50 years), burn size (25-50% and > 50% TBSA), and presence of inhalation injury confirmed by bronchoscopy (present or absent). In the Colloid Group resuscitation starts with LR and then 5% albumin will be introduced between 8 and 12 hours post burn in a ratio of 1/3 albumin to 2/3 LR. In the Crystalloid Group resuscitation is with LR only. Each group will have their study fluid maintained for the 1st 48 hours post burn and study fluids in each group will be identically titrated to the urinary output.
Details
| Full study title | The Acute Burn ResUscitation Multicenter Prospective Trial |
| Protocol number | OCR40078 |
| ClinicalTrials.gov ID | NCT04356859 |
| Phase | N/A |
Eligibility
Inclusion Criteria:
Age 鈮� 18 years
Total burn size (second and third degree) is 鈮� 25% of the TBSA
Burn center admission within 12 hours of injury.
There is a plan for formal fluid resuscitation.
Exclusion Criteria:
Significant associated trauma
High voltage (鈮� 1000 volts) electrical burns
Burn wound excision surgery within 48 hours from injury
Fresh frozen plasma (FFP) given at any time 鈮� 48 hours from injury
Hypertonic saline (HTS) given at any time 鈮� 48 hours from injury
Hydroxyethyl starch (HES) given at any time 鈮� 48 hours from injury
High dose Vitamin C infusion given at any time 鈮� 48 hours from injury
Administration of human albumin prior to randomization
Palliative comfort measures are instituted 鈮� 48 hours from injury
Pregnancy
Pre-injury chronic renal insufficiency equal to or greater than stage 3
Pre-injury chronic hepatic disease (Child-Pugh B or C)
Pre-injury left ventricular (LV) dysfunction (echocardiography LV grade II-IV or ejection fraction 鈮� 35%)
Participate in a study
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
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Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.