BurnsRESCUENCT01213914
Hemofiltration in Burns: RESCUE (Randomized Controlled Evaluation of Hemofiltration in Adult Burn Patients With Septic Shock and Acute Renal Failure)
A study testing An FDA approved continuous renal replacement device in people with Burns and Hemofiltration, run by American Burn Association at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Hemofiltration, Kidney Failure, Acute
- What is being tested?
- An FDA approved continuous renal replacement device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2011to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Doctors Hospital-Joseph M Still Burn Center
Augusta, Georgia, 30909
University of Texas Southwestern Medical Center-Burn Center Parkland Health
Dallas, Texas, 75235
US Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234
University of Kansas Hospital
Kansas City, Kansas, 66160
Loyola University Medical Center
Maywood, Illinois, 60153
Regional Medical Center at Memphis
Memphis, Tennessee, 38103
Arizona Burn Center
Phoenix, Arizona, 85008
Tampa General Hospital
Tampa, Florida, 33606
The Burn Center at Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: The American Burn Association's Randomized Controlled Evaluation of Hemofiltration in Adult Burn Patients With Septic Shock and Acute Renal Failure
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.
Read the detailed 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.
- Conditions
- Burns, Hemofiltration, Kidney Failure, Acute, Shock, Septic
- Being tested
- An FDA approved continuous renal replacement device, Control Group
- Keywords
- Burns, Hemofiltration, Vasopressins, Kidney Failure Acute, Shock, Septic
- Medical subject headings
- Burns, Acute Kidney Injury, Shock, Septic, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An FDA approved continuous renal replacement deviceDevice
Also called High volume hemofiltration
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 GroupOther
Also called Standard of care
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: first 48 hours
Secondary outcomes (6)
PaO2/FiO2 ratio and Oxygenation index
Measured: first 48 hours
Vasopressors-free days
Measured: first 14 days
Survival
Measured: 14 days, 28 days, and discharge
ICU days
Measured: Total number of days in ICU from date of Therapy Initiated through discharge
Ventilator free days
Measured: First 28 days after enrollment
Renal loss (need for long term renal replacement therapy)
Measured: greater than 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startAug 2011
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Burn Association
- Sponsor type
- University, hospital or other
- Collaborators
- United States Army Institute of Surgical Research, Tampa General Hospital, Medstar Health Research Institute, Loyola University, University of Texas Southwestern Medical Center, Valleywise Health, University of Tennessee, University of Kansas Medical Center, Doctors Hospital-Joseph M Still Burn Center
- Responsible party
- Sponsor
- Investigators
- Kevin K Chung, MD, Study chair, United States Army Institute of Surgical ResearchAmy M Sprague, MD, Study director, Doctors Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213914
- Sponsor's protocol ID
- H-09-046
- Other IDs
- W81XWH-09-2-0194, Combat Casualty Grant
- Acronym
- RESCUE
- Status last verified
- Apr 2018
- First submitted
- 30 Sep 2010
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18492867Leblanc 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.
PubMed 9177886Greenhalgh 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.
PubMed 17925660Azevedo LC, Park M, Schettino GP. Novel potential therapies for septic shock. Shock. 2008 Oct;30 Suppl 1:60-6. doi: 10.1097/SHK.0b013e318181a425.
PubMed 18704007Ratanarat R, Permpikul C. Roles of extracorporeal blood purification in sepsis. J Med Assoc Thai. 2007 May;90(5):1021-31.
PubMed 17596062Chung 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.
PubMed 19409089Piccinni 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.
PubMed 16328222Ronco 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.
PubMed 10892761Honore 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.
PubMed 11098957Wagener 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.
PubMed 18649981Cruz 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.
PubMed 19531784Gibran 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.
PubMed 34554139Chung 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.
PubMed 29178943
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The American Burn Association's Randomized Controlled Evaluation of Hemofiltration in Adult Burn Patients With Septic Shock and Acute Renal Failure
- ClinicalTrials.gov ID
- NCT01213914
- Acronym / sponsor ID
- RESCUE / H-09-046
- Conditions
- Burns, Hemofiltration, Kidney Failure, Acute, Shock, Septic
- Keywords
- Burns, Hemofiltration, Vasopressins, Kidney Failure Acute, Shock, Septic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (actual)
- Lead sponsor
- American Burn AssociationUniversity, hospital or other
- Collaborators
- United States Army Institute of Surgical Research, Tampa General Hospital, Medstar Health Research Institute, Loyola University, University of Texas Southwestern Medical Center, Valleywise Health, University of Tennessee, University of Kansas Medical Center, Doctors Hospital-Joseph M Still Burn Center
- Study start
- Aug 2011
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 4 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-volume hemofiltration at 70ml/kg/hr | Experimental | Device: An FDA approved continuous renal replacement devicePaired 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 | Other: Control GroupContemporary 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| An FDA approved continuous renal replacement deviceAlso: High volume hemofiltration70ml/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 | Device | High-volume hemofiltration at 70ml/kg/hr |
| Control GroupAlso: Standard of careBoth 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 | Control group |
Primary outcome
Vasopressor dependency index
Time frame: first 48 hours
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)
6 secondary outcomes
PaO2/FiO2 ratio and Oxygenation index
Time frame: first 48 hours
Vasopressors-free days
Time frame: first 14 days
Survival
Time frame: 14 days, 28 days, and discharge
ICU days
Time frame: Total number of days in ICU from date of Therapy Initiated through discharge
Ventilator free days
Time frame: First 28 days after enrollment
Renal loss (need for long term renal replacement therapy)
Time frame: greater than 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Background: PubMed 18492867VA/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.
- Background: PubMed 9177886Leblanc 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.
- Background: PubMed 17925660Greenhalgh 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.
- Background: PubMed 18704007Azevedo LC, Park M, Schettino GP. Novel potential therapies for septic shock. Shock. 2008 Oct;30 Suppl 1:60-6. doi: 10.1097/SHK.0b013e318181a425.
- Background: PubMed 17596062Ratanarat R, Permpikul C. Roles of extracorporeal blood purification in sepsis. J Med Assoc Thai. 2007 May;90(5):1021-31.
- Background: PubMed 19409089Chung 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.
- Background: PubMed 16328222Piccinni 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.
- Background: PubMed 10892761Ronco 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.
- Background: PubMed 11098957Honore 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.
- Background: PubMed 18649981Wagener 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.
- Background: PubMed 19531784Cruz 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.
- Derived from this study: PubMed 34554139Gibran 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin K Chung, MD study chair
United States Army Institute of Surgical Research
Amy M Sprague, MD study director
Doctors Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An FDA approved continuous renal replacement device in people with Burns and Hemofiltration, run by American Burn Association at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasopressor dependency index (time frame: first 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01213914, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.