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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-09-2-0194 | Other Grant/Funding Number | U.S. Army Medical Research and Materiel Command | |
| Combat Casualty Grant | Other Identifier | American Burn Association |
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| Name | Class |
|---|---|
| United States Army Institute of Surgical Research | FED |
| Tampa General Hospital | OTHER |
| Medstar Health Research Institute | OTHER |
| Loyola University |
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The purpose of this study is determine if High-Volume Hemofiltration in addition to 'contemporary' care will result in an improvement of select clinical outcomes when compared to 'contemporary' care alone in the treatment of critically ill patients with ARF secondary to septic shock.
Acute renal failure (ARF) is a common and devastating complication in critically ill burn patients with mortality reported to be between 80 and 100%.(3-7) Despite recent advances in burn care, the unacceptably high mortality rate in this subgroup has not changed over time. The pathogenesis of ARF in burns, similar to other critically ill populations, is often multi-factorial with one major component being sepsis induced ischemic tubular necrosis. Thus, ARF secondary to septic shock is a common and devastating condition in the burn ICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-volume hemofiltration at 70ml/kg/hr | Experimental | Paired randomization into four groups via central randomization center. Group 1: age 18-65 and <40%TBSA Group 2: age 18-65 and >40%TBSA Group 3: age >65 and <40%TBSA Group 4: age >65 and >40%TBSA |
|
| Control group | Active Comparator | Contemporary care via consideration of the Burn-Specific Sepsis Bundle adapted form the most recent Surviving Sepsis campaign recommendations and specifically modified to our patient population. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| An FDA approved continuous renal replacement device | Device | 70ml/kg/hr for treatment group for 48 hours with the following requirements:
|
| Measure | Description | Time Frame |
|---|---|---|
| Vasopressor dependency index | Vasopressor dependency index = MAP/Inotropic score • This index will correct for the inter-center variability that exists with regards to the point (minimum MAP) at which vasopressors are initiated or weaned off. Thus, this eliminates the need to 'standardize' starting/stopping criteria of vasopressors. Modified Inotropic index (30) = (dopamine dose X1)+(dobutamine dose X1)+(epi doseX100)+(norepi doseX100)+(phenylephrine doseX100)+(vasopressin doseX100) • All units recorded at each time point in mcg/kg/min Mean Arterial Pressure (mmHg) | first 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| PaO2/FiO2 ratio and Oxygenation index | first 48 hours | |
| Vasopressors-free days | first 14 days | |
| Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin K Chung, MD | United States Army Institute of Surgical Research | Study Chair |
| Amy M Sprague, MD | Doctors Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Burn Center | Phoenix | Arizona | 85008 | United States | ||
| The Burn Center at Washington Hospital Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18492867 | Background | VA/NIH Acute Renal Failure Trial Network; Palevsky PM, Zhang JH, O'Connor TZ, Chertow GM, Crowley ST, Choudhury D, Finkel K, Kellum JA, Paganini E, Schein RM, Smith MW, Swanson KM, Thompson BT, Vijayan A, Watnick S, Star RA, Peduzzi P. Intensity of renal support in critically ill patients with acute kidney injury. N Engl J Med. 2008 Jul 3;359(1):7-20. doi: 10.1056/NEJMoa0802639. Epub 2008 May 20. | |
| 9177886 |
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| OTHER |
| University of Texas Southwestern Medical Center | OTHER |
| Valleywise Health | OTHER |
| University of Tennessee | OTHER |
| University of Kansas Medical Center | OTHER |
| Doctors Hospital-Joseph M Still Burn Center | UNKNOWN |
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|
|
| Control Group | Other | Both groups will receive 'contemporary' care via consideration of the Burn-specific Sepsis Bundle adapted from the most recent Surviving Sepsis Campaign (SSC) (1) recommendations and specifically modified to our patient population |
|
|
| 14 days, 28 days, and discharge |
| ICU days | Total number of days in ICU from date of Therapy Initiated through discharge |
| Ventilator free days | First 28 days after enrollment |
| Renal loss (need for long term renal replacement therapy) | greater than 28 days |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Doctors Hospital-Joseph M Still Burn Center | Augusta | Georgia | 30909 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | United States |
| Regional Medical Center at Memphis | Memphis | Tennessee | 38103 | United States |
| University of Texas Southwestern Medical Center-Burn Center Parkland Health | Dallas | Texas | 75235 | United States |
| US Army Institute of Surgical Research | Fort Sam Houston | Texas | 78234 | United States |
| Background |
| Leblanc M, Thibeault Y, Querin S. Continuous haemofiltration and haemodiafiltration for acute renal failure in severely burned patients. Burns. 1997 Mar;23(2):160-5. doi: 10.1016/s0305-4179(96)00085-x. |
| 17925660 | Background | Greenhalgh DG, Saffle JR, Holmes JH 4th, Gamelli RL, Palmieri TL, Horton JW, Tompkins RG, Traber DL, Mozingo DW, Deitch EA, Goodwin CW, Herndon DN, Gallagher JJ, Sanford AP, Jeng JC, Ahrenholz DH, Neely AN, O'Mara MS, Wolf SE, Purdue GF, Garner WL, Yowler CJ, Latenser BA; American Burn Association Consensus Conference on Burn Sepsis and Infection Group. American Burn Association consensus conference to define sepsis and infection in burns. J Burn Care Res. 2007 Nov-Dec;28(6):776-90. doi: 10.1097/BCR.0b013e3181599bc9. |
| 18704007 | Background | Azevedo LC, Park M, Schettino GP. Novel potential therapies for septic shock. Shock. 2008 Oct;30 Suppl 1:60-6. doi: 10.1097/SHK.0b013e318181a425. |
| 17596062 | Background | Ratanarat R, Permpikul C. Roles of extracorporeal blood purification in sepsis. J Med Assoc Thai. 2007 May;90(5):1021-31. |
| 19409089 | Background | Chung KK, Lundy JB, Matson JR, Renz EM, White CE, King BT, Barillo DJ, Jones JA, Cancio LC, Blackbourne LH, Wolf SE. Continuous venovenous hemofiltration in severely burned patients with acute kidney injury: a cohort study. Crit Care. 2009;13(3):R62. doi: 10.1186/cc7801. Epub 2009 May 1. |
| 16328222 | Background | Piccinni P, Dan M, Barbacini S, Carraro R, Lieta E, Marafon S, Zamperetti N, Brendolan A, D'Intini V, Tetta C, Bellomo R, Ronco C. Early isovolaemic haemofiltration in oliguric patients with septic shock. Intensive Care Med. 2006 Jan;32(1):80-6. doi: 10.1007/s00134-005-2815-x. Epub 2005 Nov 18. |
| 10892761 | Background | Ronco C, Bellomo R, Homel P, Brendolan A, Dan M, Piccinni P, La Greca G. Effects of different doses in continuous veno-venous haemofiltration on outcomes of acute renal failure: a prospective randomised trial. Lancet. 2000 Jul 1;356(9223):26-30. doi: 10.1016/S0140-6736(00)02430-2. |
| 11098957 | Background | Honore PM, Jamez J, Wauthier M, Lee PA, Dugernier T, Pirenne B, Hanique G, Matson JR. Prospective evaluation of short-term, high-volume isovolemic hemofiltration on the hemodynamic course and outcome in patients with intractable circulatory failure resulting from septic shock. Crit Care Med. 2000 Nov;28(11):3581-7. doi: 10.1097/00003246-200011000-00001. |
| 18649981 | Background | Wagener G, Gubitosa G, Wang S, Borregaard N, Kim M, Lee HT. Urinary neutrophil gelatinase-associated lipocalin and acute kidney injury after cardiac surgery. Am J Kidney Dis. 2008 Sep;52(3):425-33. doi: 10.1053/j.ajkd.2008.05.018. Epub 2008 Jul 23. |
| 19531784 | Background | Cruz DN, Antonelli M, Fumagalli R, Foltran F, Brienza N, Donati A, Malcangi V, Petrini F, Volta G, Bobbio Pallavicini FM, Rottoli F, Giunta F, Ronco C. Early use of polymyxin B hemoperfusion in abdominal septic shock: the EUPHAS randomized controlled trial. JAMA. 2009 Jun 17;301(23):2445-52. doi: 10.1001/jama.2009.856. |
| 34554139 | Derived | Gibran NS, Shipper E, Phuong J, Braverman M, Bixby P, Price MA, Bulger EM; NTRAP Burns & Reconstructive Surgery Panel Group. Developing a national trauma research action plan: Results from the Burn Research Gap Delphi Survey. J Trauma Acute Care Surg. 2022 Jan 1;92(1):201-212. doi: 10.1097/TA.0000000000003409. |
| 29178943 | Derived | Chung KK, Coates EC, Smith DJ Jr, Karlnoski RA, Hickerson WL, Arnold-Ross AL, Mosier MJ, Halerz M, Sprague AM, Mullins RF, Caruso DM, Albrecht M, Arnoldo BD, Burris AM, Taylor SL, Wolf SE; Randomized controlled Evaluation of high-volume hemofiltration in adult burn patients with Septic shoCk and acUte kidnEy injury (RESCUE) Investigators. High-volume hemofiltration in adult burn patients with septic shock and acute kidney injury: a multicenter randomized controlled trial. Crit Care. 2017 Nov 25;21(1):289. doi: 10.1186/s13054-017-1878-8. |
| ID | Term |
|---|---|
| D002056 | Burns |
| D058186 | Acute Kidney Injury |
| D012772 | Shock, Septic |
| D003919 | Diabetes Insipidus |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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