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

NCT01213914 | Unknown DMC

• 3 other identifiers: H-09-046W81XWH-09-2-0194Combat Casualty Grant
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Burns; Hemofiltration; Kidney Failure, Acute; Shock, Septic

Keywords

Burns; Hemofiltration; Vasopressins; Kidney Failure Acute; Shock, Septic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• PaO2/FiO2 ratio and Oxygenation index

  first 48 hours

• Vasopressors-free days

  first 14 days

• Survival

  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

Study Arms (2)

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

Device: An FDA approved continuous renal replacement device

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.

Other: Control Group

Interventions

An FDA approved continuous renal replacement device 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

Also known as: High volume hemofiltration

High-volume hemofiltration at 70ml/kg/hr

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

Also known as: Standard of care

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American Burn Association: lead
• United States Army Institute of Surgical Research: collaborator
• Tampa General Hospital: collaborator
• Medstar Health Research Institute: collaborator
• Loyola University: collaborator
• University of Texas Southwestern Medical Center: collaborator
• Valleywise Health: collaborator
• University of Tennessee: collaborator
• University of Kansas Medical Center: collaborator
• Doctors Hospital-Joseph M Still Burn Center: collaborator

Study Sites (9)

Arizona Burn Center

Phoenix, Arizona, 85008, United States

Location

The Burn Center at Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Doctors Hospital-Joseph M Still Burn Center

Augusta, Georgia, 30909, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Regional Medical Center at Memphis

Memphis, Tennessee, 38103, United States

Location

University of Texas Southwestern Medical Center-Burn Center Parkland Health

Dallas, Texas, 75235, United States

Location

US Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (13)

• 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.

  PMID: 18492867 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.

  PMID: 9177886 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.

  PMID: 17925660 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.

  PMID: 18704007 BACKGROUND

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

  PMID: 17596062 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.

  PMID: 19409089 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.

  PMID: 16328222 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.

  PMID: 10892761 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.

  PMID: 11098957 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.

  PMID: 18649981 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.

  PMID: 19531784 BACKGROUND

• 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.

  PMID: 34554139 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.

  PMID: 29178943 DERIVED

MeSH Terms

Conditions

Burns; Acute Kidney Injury; Shock, Septic; Diabetes Insipidus

Interventions

Control Groups; Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kevin K Chung, MD

  United States Army Institute of Surgical Research

  STUDY CHAIR

• Amy M Sprague, MD

  Doctors Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 4, 2010
• Study Start: August 1, 2011
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: April 6, 2018

Record last verified: 2018-04

Locations

US (9)