Hemofiltration in Burns: RESCUE (Randomized Controlled Evaluation of Hemofiltration in Adult Burn Patients With Septic Shock and Acute Renal Failure)

Burns Clinical Trial

— RESCUE  

Official title:

The American Burn Association's Randomized Controlled Evaluation of Hemofiltration in Adult Burn Patients With Septic Shock and Acute Renal Failure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01213914
• Other study ID #: H-09-046
• Secondary ID: W81XWH-09-2-0194
• Status: Active, not recruiting
• Phase: N/A
• First received: September 30, 2010
• Last updated: April 5, 2018
• Start date: August 2011
• Est. completion date: September 2018

Study information

• Verified date: April 2018
• Source: United States Army Institute of Surgical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 37
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients admitted to the burn intensive care unit (ICU) with burns of any size

• 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:

• Age <18

• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Burns
• Hemofiltration
• Kidney Failure, Acute
• Renal Insufficiency
• Shock
• Shock, Septic

Intervention

Device:
• 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

Other:
• 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

Locations

Country	Name	City	State
United States	Doctors Hospital-Joseph M Still Burn Center	Augusta	Georgia
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	University of Kansas Hospital	Kansas City	Kansas
United States	Loyola University Medical Center	Maywood	Illinois
United States	Regional Medical Center at Memphis	Memphis	Tennessee
United States	Arizona Burn Center	Phoenix	Arizona
United States	Tampa General Hospital	Tampa	Florida
United States	The Burn Center at Washington Hospital Center	Washington	District of Columbia

Sponsors (10)

Lead Sponsor	Collaborator
American Burn Association	Doctors Hospital-Joseph M Still Burn Center, Loyola University, Maricopa Integrated Health System, Tampa General Hospital, United States Army Institute of Surgical Research, University of Kansas Medical Center, University of Tennessee Health Science Center, University of Texas Southwestern Medical Center, Washington Hospital Center

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Leblanc M, Thibeault Y, Quérin S. Continuous haemofiltration and haemodiafiltration for acute renal failure in severely burned patients. Burns. 1997 Mar;23(2):160-5. — View Citation

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. Epub 2005 Nov 18. — View Citation

Ratanarat R, Permpikul C. Roles of extracorporeal blood purification in sepsis. J Med Assoc Thai. 2007 May;90(5):1021-31. — View Citation

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. — View Citation

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. Erratum in: N Engl J Med. 2009 Dec 10;361(24):2391. — View Citation

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. Erratum in: Am J Kidney Dis. 2008 Oct;52(4):810. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	PaO2/FiO2 ratio and Oxygenation index		first 48 hours
Secondary	Vasopressors-free days		first 14 days
Secondary	Survival		14 days, 28 days, and discharge
Secondary	ICU days		Total number of days in ICU from date of Therapy Initiated through discharge
Secondary	Ventilator free days		First 28 days after enrollment
Secondary	Renal loss (need for long term renal replacement therapy)		greater than 28 days