Background: Sepsis and septic shock occur commonly in severe burns. Acute kidney injury (AKI) is also common and often results as a consequence of sepsis. Mortality is unacceptably high in burn patients who develop AKI requiring renal replacement therapy and is presumed to be even higher when combined with septic shock. We hypothesized that high-volume hemofiltration (HVHF) as a blood purification technique would be beneficial in this population. Methods: We conducted a multicenter, prospective, randomized, controlled clinical trial to evaluate the impact of HVHF on the hemodynamic profile of burn patients with septic shock and AKI involving seven burn centers in the United States. Subjects randomized to the HVHF were prescribed a dose of 70 ml/kg/hour for 48 hours while control subjects were managed in standard fashion in accordance with local practices.
Acute kidney injury (AKI) after severe burns is historically associated with a high mortality. Over the past two decades, various modes of renal replacement therapy (RRT) have been used in this population. The purpose of this multicenter study was to evaluate demographic, treatment, and outcomes data among severe burn patients treated with RRT collectively at various burn centers around the United States. After institutional review board approval, a multicenter observational study was conducted. All adult patients aged 18 or older, admitted with severe burns who were placed on RRT for acute indications but not randomized into a concurrently enrolling interventional trial, were included. Across eight participating burn centers, 171 subjects were enrolled during a 4-year period. Complete data were available in 170 subjects with a mean age of 51 ± 17, percent total body surface area burn of 38 ± 26% and injury severity score of 27 ± 21. Eighty percent of subjects were male and 34% were diagnosed with smoke inhalation injury. The preferred mode of therapy was continuous venovenous hemofiltration at a mean delivered dose of 37 ± 19 (ml/kg/hour) and a treatment duration of 13 ± 24 days. Overall, in hospital, mortality was 50%. Among survivors, 21% required RRT on discharge from the hospital while 9% continued to require RRT 6 months after discharge. This is the first multicenter cohort of burn patients who underwent RRT reported to date. Overall mortality is comparable to other critically ill populations who undergo RRT. Most patients who survive to discharge eventually recover renal function.
Managing multicenter clinical trials (MCTs) is demanding and complex. The Randomized controlled Evaluation of high-volume hemofiltration in adult burn patients with Septic shoCk and acUte kidnEy injury (RESCUE) trial was a prospective, MCT involving the impact of high-volume hemofiltration continuous renal replacement therapy on patients experiencing acute kidney injury and septic shock. Ten clinical burn centers from across the United States were recruited to enroll a target sample size of 120 subjects. This manuscripts reviews some of the obstacles and knowledge gained while coordinating the RESCUE trial. The first subject was enrolled in February 2012, 22 months after initial IRB approval and 29 months from the time the grant was awarded. The RESCUE team consisted of personnel at each site, including the lead site, a data coordination center, data safety monitoring board, steering committees, and the sponsor. Seven clinical sites had enrolled 37 subjects when enrollment stopped in February 2016. Obstacles included changes in institutional review boards, multiple layers of review, staffing changes, creation and amendment of study documents and procedures, and finalization of contracts. Successful completion of a MCT requires a highly functional research team with sufficient patient population, expertise, and research infrastructure. Additionally, realistic timelines must be established with strategies to overcome challenges. Inevitable obstacles should be discussed in the pretrial phase and continuous correspondence must be maintained with all relevant research parties throughout all phases of study.
Background Positive Focused Assessment with Sonography in Trauma (FAST) and hypotension often indicates urgent surgery. An abdomen/pelvis CT (apCT) may allow less invasive management but the delay may be associated with adverse outcomes. Methods Patients in the Prospective Observational Multicenter Major Trauma Transfusion study with hypotension and a positive FAST (HF+) who underwent a CT (apCT+) were compared to those who did not. Results Of the 92 HF+ identified, 32(35%) underwent apCT during initial evaluation and apCT was associated with decreased odds of an emergency operation, OR 0.11 95% CI (0.001–0.116) and increased odds of angiographic intervention, OR 14.3 95% CI (1.5–135). There was no significant difference in 30 day mortality or need for dialysis. Conclusion An apCt in HF+ patients is associated with reduced odds of emergency surgery, but not mortality. Select HF+ patients can safely undergo apCT to obtain clinically useful information.
Introduction Burn care continues to focus on providing enough fluid resuscitation to perfuse end organs with the least amount of fluid necessary in order to prevent complications related to excess fluid. In this observational trial of 5 ABA-verified burn centers that utilized the Burn Navigator (BN), a clinical decision support tool, we sought to examine resuscitation-related complications that occurred in the first 48 hours after burn injury. Since minimal literature exists regarding the incidence of resuscitation-related complications in the acute phase after burn injury, we aimed to present our data for future comparison. Methods An observational study of adult patients undergoing burn resuscitation utilizing the BN was conducted. Data were gathered hourly for the first 48 hours for patients on fluid infusion rates, laboratory data, critical care elements to include ventilator settings and clinically relevant outcomes. Morbidities were classified based on each burn center’s definition as related to over or under-resuscitation and variables associated with these outcomes were extracted from the data set. Results Three hundred patients were enrolled into the study, and 156 resuscitation-related complications were documented in 92 patients in the first 48 hours after admission. Compartment syndromes (abdominal, extremity, ocular) accounted for 62 (40%) of the complications. ARDS occurred in 9 patients. ARDS patients were the most severely injured, reflected by highest Baux score. None of the ARDS patients had an inhalation injury. The under-resuscitation morbidities of shock and acute kidney injury accounted for 81 (52%) of the complications. Patients experiencing shock received greater than the Parkland formula in the first 24 hours after injury. Most patients with AKI continued to make adequate urine during their resuscitation period, with 59% making an average of >30 ml/hr over the first 24 hours. Nearly half of patients with AKI were placed on renal replacement therapy in the first 48 hours. Seventeen patients (18.5%) experienced both a compartment syndrome and either AKI or shock. Conclusions This large observational study demonstrates variables associated with different complications across 5 major burn centers and shows that complications associated with over- and under-resuscitation can occur within the same patient during resuscitation after burn injury. Additional comparative studies are needed to better understand the cause of these complications, to determine the incidence of these complications in a larger population and criteria used to define each complication.
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