Plasma Resuscitation WithOut Lung Injury
Overview
- Phase
- Phase 4
- Intervention
- Pathogen-Reduced Plasma
- Conditions
- Burns
- Sponsor
- Coalition for National Trauma Research
- Enrollment
- 13
- Locations
- 6
- Primary Endpoint
- The total volume of all resuscitation fluids delivered between hours 0-24 postern, in ml/kg.
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
The treatment of patients with major burns requires resuscitation with massive amounts of fluid, typically a type of salt water that is given by vein. This frequently results in injury to vital organs, especially the lungs and kidneys, and even in death. In this study, the investigators propose to use plasma, a specially prepared blood product made from the liquid part of blood, that has undergone special treatment to reduce the risk of disease transmission. The aims include 1) reduce the amount of fluid given during the first 24 hours after a burn 2) reduce the incidence of lung injury and other complications related to the administration of funds and 3) determine if the blood product has any effect on inflammation. An overall decrease the amount of fluids that burn patients receive should decrease the potential for lung injury, decrease days in the hospital, and improve survival.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 years
- •Weight \> 40 kg
- •Initial assessment of thermal injury size ≥ 20% TBSA
- •Admitted to the burn center and enroll able within 8 hours of injury
- •Expected to receive intravenous resuscitation fluids for at least 24 hours after injury
- •Expected to live \> 24 hours after injury
Exclusion Criteria
- •Chemical injury
- •Deep electric injury
- •Associated non-thermal injuries with estimated Injury Severity Score \> 25
- •Inability to obtain informed consent
- •Decision not to treat due to injury severity or other factors
- •Patient age \> 65 years or \< 18 years
- •Presence of anoxic brain injury that is not expected to result in complete recover
- •Patent already receiving plasma infusion, or judged to be likely to require plasma infusion
- •Patent already receiving "rescue procedures" (albumin infusion, CRRT, TPE, or high-dose ascorbic acid)
- •Existence of pre-morbid conditions: Congestive heart failure (NYHA Class IV); End-stage kidney disease (dialysis patient); Cirrhosis of the liver; Oxygen-dependent chronic obstructive pulmonary disease; Malignancy currently under treatment; Previous bilateral lower extremity amputations
Arms & Interventions
Plasma
Pathogen-Reduced Plasma resuscitation
Intervention: Pathogen-Reduced Plasma
Crystalloid
Standardized crystalloid resuscitation
Intervention: Crystalloid Solutions
Outcomes
Primary Outcomes
The total volume of all resuscitation fluids delivered between hours 0-24 postern, in ml/kg.
Time Frame: 24 hours
The total volume of all resuscitation fluids delivered between hours 0-24 postburn, in ml/kg
Secondary Outcomes
- Metabolic acidosis(48 hours)
- Total resuscitation volume in ml/kg(48 hours)
- Total 24 hour resuscitation volume in ml/kg/TBSA(24 hours)
- Total 48 hour resuscitation volume in ml/kg/TBSA(48 hours)
- Hemodynamic instability(48 hours)
- Incidence of "rescue" (b)(48 hours)
- Incidence of "rescue" (a)(48 hours)
- Acute Respiratory Distress Syndrome(7 days)
- Cytokines(48 hours)
- Mechanical ventilation(28 days)
- Incidence of "rescue" (c)(24 hours)
- Intensive Care Unit days(28 days)
- Multi-Organ Failure Assessment(7 days)
- Thromboembolic events(7 days)
- Patient reported outcomes(6 months)
- Syndecan-1 levels(48 hours)
- Transfusion-Related Acute Lung Injury(72 hours)
- Mortality(throughout study completion, an average of 1 year)