Hemofiltration in Burns: RESCUE (Randomized Controlled Evaluation of Hemofiltration in Adult Burn Patients With Septic Shock and Acute Renal Failure)
NCT ID: NCT01213914
Last Updated: 2018-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
37 participants
INTERVENTIONAL
2011-08-31
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High-volume hemofiltration at 70ml/kg/hr
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
An FDA approved continuous renal replacement device
70ml/kg/hr for treatment group for 48 hours with the following requirements:
* double lumen dialysis catheter should be placed in the internal jugular or femoral vein
* Anticoagulation will be determined by prescribing physician
* Use of 1.4 m2 or larger biocompatible synthetic hollow-fiber dialysis membrane that is changed every 24 hours
* Blood flow rate will be set to ensure a filtration fraction of no more than 25%
* Monitoring for electrolytes (specifically K+, Mg, Ca, and phos) during HVHF must be performed at least every 6 hours
* Replacement fluids will be bicarbonate-buffered with appropriate adjustments when citrate-anticoagulation is utilized
* All antibiotics will be dose adjusted for renal replacement therapy
Control group
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.
Control Group
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
Interventions
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An FDA approved continuous renal replacement device
70ml/kg/hr for treatment group for 48 hours with the following requirements:
* double lumen dialysis catheter should be placed in the internal jugular or femoral vein
* Anticoagulation will be determined by prescribing physician
* Use of 1.4 m2 or larger biocompatible synthetic hollow-fiber dialysis membrane that is changed every 24 hours
* Blood flow rate will be set to ensure a filtration fraction of no more than 25%
* Monitoring for electrolytes (specifically K+, Mg, Ca, and phos) during HVHF must be performed at least every 6 hours
* Replacement fluids will be bicarbonate-buffered with appropriate adjustments when citrate-anticoagulation is utilized
* All antibiotics will be dose adjusted for renal replacement therapy
Control Group
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Acute renal failure as previously defined by the Veterans Affairs/ National Institutes of Health (VA/NIH) Acute Renal Failure Trial Network study investigators(2)
* Patient is \> 48 hours post-burn and in Septic Shock
* Patients 18 or older
* Patient/legally authorized representative willing to provide consent
Exclusion Criteria
* Non-thermal injury (exfoliating skin disorders or necrotizing fasciitis)
* Pre-admission diagnosis of end stage renal failure
* Patients already on renal replacement therapy for more than 24 hours
* Patient not expected to survive more than 24 hours after randomization.
* Pregnancy
* Prisoners
18 Years
ALL
No
Sponsors
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United States Army Institute of Surgical Research
FED
Tampa General Hospital
OTHER
Medstar Health Research Institute
OTHER
Loyola University
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
American Burn Association
OTHER
Responsible Party
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Principal Investigators
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Kevin K Chung, MD
Role: STUDY_CHAIR
United States Army Institute of Surgical Research
Amy M Sprague, MD
Role: STUDY_DIRECTOR
Doctors Hospital
Locations
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Arizona Burn Center
Phoenix, Arizona, United States
The Burn Center at Washington Hospital Center
Washington D.C., District of Columbia, United States
Tampa General Hospital
Tampa, Florida, United States
Doctors Hospital-Joseph M Still Burn Center
Augusta, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Regional Medical Center at Memphis
Memphis, Tennessee, United States
University of Texas Southwestern Medical Center-Burn Center Parkland Health
Dallas, Texas, United States
US Army Institute of Surgical Research
Fort Sam Houston, Texas, United States
Countries
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References
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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.
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.
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.
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.
Ratanarat R, Permpikul C. Roles of extracorporeal blood purification in sepsis. J Med Assoc Thai. 2007 May;90(5):1021-31.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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W81XWH-09-2-0194
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Combat Casualty Grant
Identifier Type: OTHER
Identifier Source: secondary_id
H-09-046
Identifier Type: -
Identifier Source: org_study_id
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