Back to resultsTherapeutic Plasma Exchange Adsorption Diafiltration (PEAF)
Primary Purpose
Septic Shock, Multiple Organ Dysfunction Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PEAF
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock
Eligibility Criteria
Inclusion Criteria:
- Age, gender: 18-75 years old, male or female;
- basic conditions: 20 ≤ APACHE II score ≤ 35 points and 10 ≤ Sequential Organ Failure Assessment(SOFA)≤ 18 points;
- septic shock : On the basis of sepsis, after adequate fluid resuscitation, sustained hypotension requires maintenance of vasoactive drugs, mean arterial pressure（MAP）≥ 60 mmHg and Lactate ≥ 2.0 mmol/L; MODS: if the patient's SOFA score is ≥2 points, it means there is organ dysfunction. When the patient has two or more organ dysfunctions, it is MODS.
Exclusion Criteria:
- can not remove the cause (surgical patients refused surgery, pan drug resistant infection without drug use)
- Allergic to AMPLYA™ series
- Presence of relative or absolute contraindications to PFA
- MODS caused by severe liver disease
- malignant tumors
- Chronic end-stage disease (predicted to survive no more than one month)
- Maternal and possibly pregnant women
- participated in drug clinical trials within three months
- Admission from an other ICU where the patient remained for more than 24 hours
Sites / Locations
- Dongguan Fifth People's Hospital (Taiping Hospital)
- Guangzhou General Hospital of Guangzhou Military Region
- School of Public Health, Southern Medical University
- Shenzhen Luohu People's hospitial
- Shenzhen People's Hospital
- The eighth affiliated hospital, Sun Yat-Sen university
- Peking University Shenzhen Hospital
- Shenzhen Sixth People's Hospital (Nanshan Hospital)
- Affiliated Baoan Hospital of Shenzhen, Southern Medical University (People' hospital of Baoan District)
- Shenzhen Longgang Central Hospital
- Shenzhen hospital of southern medicial university
- Shenzhen Second People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PEAF
Control group
Arm Description
Intervention group:the patient will receive treatment with PEAF immediately after randomization.PEAF that is TPE (20ml/kg/d Fresh frozen plasma, Blood pump: 120ml/min, replacement pump 20ml/kg/min, dialysate pump 0ml/kg/min, waste pump 20ml/kg/min, plasma exchange 1 hour) plus plasma-filtration adsorption(PFA) (Blood pump: 120ml/min, Plasma separation rate 25-30%, PFA with acute multitherapeutic system (AMPLYA™ Italy) ≥30ml/min) and High volume plasma diafiltration (HVPDF) with CUREFLO™(ACF180W Japan) or Ultraflux® (AV1000S Fresenius Germany) , Blood pump same as PFA , replacement fluid pump 2000ml/h, dialysate pump 2000ml/h, waste pump 4000ml/h),with PFA and HVPDF for 15 hours in the first 3 days. If hemodynamically unstable or acute kidney injury(AKI) stage 2or 3,continue High volume hemofiltration(HVHF).Same protocol with control group after 3days.
HVHF for septic shock with MODS is permitted in Control group routinely（Blood pump: 200ml/min, replacement fluid pump 45ml/kg/min, dialysate pump 45ml/kg/min, waste pump 90ml/kg/min, and high-volume hemofiltration for 16 hours with CUREFLO™(ACF180W Japan) or Ultraflux® (AV1000S Fresenius Germany) in the first 3 days after randomization.If hemodynamically unstable or AKI stage 2or 3,continue HVHF.
Outcomes
Primary Outcome Measures
All-cause mortality within 28 days after randomization
efficacy
Secondary Outcome Measures
All-cause mortality within 90 days from randomization
efficacy
free hours of vasoactive drugs from randomization
efficacy
Full Information
NCT ID
NCT03589378
First Posted
April 22, 2018
Last Updated
August 27, 2018
Sponsor
Shenzhen Second People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03589378
Brief Title
Therapeutic Plasma Exchange Adsorption Diafiltration
Acronym
PEAF
Official Title
Efficacy of PEAF for Septic Shock With Multiple Organ Dysfunction Syndrome in ICU:A Multicenter,Open-Parallelled ,Randomized and Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 13, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Second People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of coupled therapeutic plasma exchange adsorption diafiltration (PEAF )for treating septic shock with multiple organ dysfunction syndrome patients in ICU.
Detailed Description
Septic shock with multiple organ dysfunction syndrome (MODS) is a life-threatening clinical condition due to coagulant disorder immunoparalysis to infection. For this reason the extracorporeal therapies for the treatment of septic shock with MODS have become widespread in the ICU and, at the same time, new extracorporeal depurative techniques have been developed for the removal of inflammatory mediators. One of these techniques is therapeutic plasma exchange (TPE) that remove pathologically elevated cytokines and simultaneously to replace protective plasmatic factors. other techniques is coupled plasma-filtration adsorption (CPFA) that uses a sorbent once the separation between plasma and blood has been obtained with a plasma filter. The others is Plasma dialysis filtration(PDF) that can remove inflammatory mediators for patients with multiple organ dysfunction syndrome.The purpose of this study is to evaluate the efficacy of PEAF (coupled therapeutic plasma exchange adsorption diafiltration )for treating septic shock with multiple organ dysfunction syndrome patients in ICU.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Multiple Organ Dysfunction Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a Multicenter,Randomized and Controlled Clinical Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PEAF
Arm Type
Experimental
Arm Description
Intervention group:the patient will receive treatment with PEAF immediately after randomization.PEAF that is TPE (20ml/kg/d Fresh frozen plasma, Blood pump: 120ml/min, replacement pump 20ml/kg/min, dialysate pump 0ml/kg/min, waste pump 20ml/kg/min, plasma exchange 1 hour) plus plasma-filtration adsorption(PFA) (Blood pump: 120ml/min, Plasma separation rate 25-30%, PFA with acute multitherapeutic system (AMPLYA™ Italy) ≥30ml/min) and High volume plasma diafiltration (HVPDF) with CUREFLO™(ACF180W Japan) or Ultraflux® (AV1000S Fresenius Germany) , Blood pump same as PFA , replacement fluid pump 2000ml/h, dialysate pump 2000ml/h, waste pump 4000ml/h),with PFA and HVPDF for 15 hours in the first 3 days. If hemodynamically unstable or acute kidney injury(AKI) stage 2or 3,continue High volume hemofiltration(HVHF).Same protocol with control group after 3days.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
HVHF for septic shock with MODS is permitted in Control group routinely（Blood pump: 200ml/min, replacement fluid pump 45ml/kg/min, dialysate pump 45ml/kg/min, waste pump 90ml/kg/min, and high-volume hemofiltration for 16 hours with CUREFLO™(ACF180W Japan) or Ultraflux® (AV1000S Fresenius Germany) in the first 3 days after randomization.If hemodynamically unstable or AKI stage 2or 3,continue HVHF.
Intervention Type
Procedure
Intervention Name(s)
PEAF
Intervention Description
PEAF that is therapeutic plasma exchange (TPE) with 20ml/kg/d Fresh frozen plasma (Blood pump: 120ml/min, replacement pump 20ml/kg/min, dialysate pump 0ml/kg/min, waste pump 20ml/kg/min, plasma exchange 1 hour) plus plasma filtration adsorption (PFA ) with acute multitherapeutic system( AMPLYA™ ITALY) ≥30ml/min lasting 15 hours plus High volume plasma diafiltration (HVPDF) with CUREFLO™(ACF180W Japan) or Ultraflux® (AV1000S Fresenius Germany) Blood pump: 120ml/min, replacement fluid pump 2000ml/h, dialysate pump 2000ml/h, waste pump 4000ml/h,and with high-volume plasma diafiltration for 15 hours）in the first 3 days. the treatment after three days later is same as the control group.
Primary Outcome Measure Information:
Title
All-cause mortality within 28 days after randomization
Description
efficacy
Time Frame
28 days after randomization
Secondary Outcome Measure Information:
Title
All-cause mortality within 90 days from randomization
Description
efficacy
Time Frame
90 days from randomization
Title
free hours of vasoactive drugs from randomization
Description
efficacy
Time Frame
14 days after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age, gender: 18-75 years old, male or female;
basic conditions: 20 ≤ APACHE II score ≤ 35 points and 10 ≤ Sequential Organ Failure Assessment(SOFA)≤ 18 points;
septic shock : On the basis of sepsis, after adequate fluid resuscitation, sustained hypotension requires maintenance of vasoactive drugs, mean arterial pressure（MAP）≥ 60 mmHg and Lactate ≥ 2.0 mmol/L; MODS: if the patient's SOFA score is ≥2 points, it means there is organ dysfunction. When the patient has two or more organ dysfunctions, it is MODS.
Exclusion Criteria:
can not remove the cause (surgical patients refused surgery, pan drug resistant infection without drug use)
Allergic to AMPLYA™ series
Presence of relative or absolute contraindications to PFA
MODS caused by severe liver disease
malignant tumors
Chronic end-stage disease (predicted to survive no more than one month)
Maternal and possibly pregnant women
participated in drug clinical trials within three months
Admission from an other ICU where the patient remained for more than 24 hours
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Wu, MD
Phone
+86-0755-83366388
Email
boshiyy@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yongwen Feng
Phone
+86-0755-83366388
Email
fengyongwen2008@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Wu, MD
Organizational Affiliation
Shenzhen Second People's Hospita
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongguan Fifth People's Hospital (Taiping Hospital)
City
Dongguan
State/Province
Guang Dong
ZIP/Postal Code
511761
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Chen, MD Ph.D
Phone
+86-0769-85010257
Email
chenyi_icu@163.com
First Name & Middle Initial & Last Name & Degree
Yi Chen, MD Ph.D
Facility Name
Guangzhou General Hospital of Guangzhou Military Region
City
Guangzhou
State/Province
Guang Dong
ZIP/Postal Code
510010
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huansheng Tong, MD Ph.D
Phone
+86-020-88653353
Email
fimmuths@163.com
First Name & Middle Initial & Last Name & Degree
Huansheng Tong, MD PhD
Facility Name
School of Public Health, Southern Medical University
City
Guangzhou
State/Province
Guang Dong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengli Zhang, Ph.D
Phone
+86-020-61648311
Email
asl0418@126.com
First Name & Middle Initial & Last Name & Degree
Shengli Zhang, Ph.D
Facility Name
Shenzhen Luohu People's hospitial
City
Shenzhen
State/Province
Guang Dong
ZIP/Postal Code
518001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mian Peng, MD
Phone
+86-0755-25650005
Email
1031994903@qq.com
First Name & Middle Initial & Last Name & Degree
Mian Peng, MD
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guang Dong
ZIP/Postal Code
518020
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huaisheng Chen, MD
Phone
+86-0755-25533018
Email
sunshinic@hotmail.com
First Name & Middle Initial & Last Name & Degree
Huaisheng Chen, MD
Facility Name
The eighth affiliated hospital, Sun Yat-Sen university
City
Shenzhen
State/Province
Guang Dong
ZIP/Postal Code
518033
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao LI, MD
Phone
+86-0755-83982222
Email
snapzero@163.com
First Name & Middle Initial & Last Name & Degree
Hao LI, MD
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guang Dong
ZIP/Postal Code
518036
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Huang, MD
Phone
+86-0755-83923333
Email
hl0248@outlook.com
First Name & Middle Initial & Last Name & Degree
Lei Huang, MD
Facility Name
Shenzhen Sixth People's Hospital (Nanshan Hospital)
City
ShenZhen
State/Province
Guang Dong
ZIP/Postal Code
518052
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JING lan Wu, MD
Phone
+86-0755-26553111
Email
doctorwu99@126.com
First Name & Middle Initial & Last Name & Degree
JING lan Wu, MD
Facility Name
Affiliated Baoan Hospital of Shenzhen, Southern Medical University (People' hospital of Baoan District)
City
Shenzhen
State/Province
Guang Dong
ZIP/Postal Code
518101
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baojun Yu, MD
Phone
+86-0755-27788311
Email
ybjhb@163.com
First Name & Middle Initial & Last Name & Degree
Baojun Yu, MD
Facility Name
Shenzhen Longgang Central Hospital
City
Shenzhen
State/Province
Guang Dong
ZIP/Postal Code
518116
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronglin Chen, MD
Phone
+86-0755-84806933
Email
13510156528@126.com
First Name & Middle Initial & Last Name & Degree
Ronglin Chen, MD
Facility Name
Shenzhen hospital of southern medicial university
City
Shenzhen
State/Province
Guang Dong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Liu, MD
Phone
+86-0755-23329999
Email
liuyongjoy@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yong Liu, MD
Facility Name
Shenzhen Second People's Hospital
City
Shenzhen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Wu, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
27322218
Citation
Schwartz J, Padmanabhan A, Aqui N, Balogun RA, Connelly-Smith L, Delaney M, Dunbar NM, Witt V, Wu Y, Shaz BH. Guidelines on the Use of Therapeutic Apheresis in Clinical Practice-Evidence-Based Approach from the Writing Committee of the American Society for Apheresis: The Seventh Special Issue. J Clin Apher. 2016 Jun;31(3):149-62. doi: 10.1002/jca.21470.
Results Reference
background
PubMed Identifier
24401721
Citation
Livigni S, Bertolini G, Rossi C, Ferrari F, Giardino M, Pozzato M, Remuzzi G; GiViTI: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva (Italian Group for the Evaluation of Interventions in Intensive Care Medicine) is an independent collaboration network of Italian Intensive Care units. Efficacy of coupled plasma filtration adsorption (CPFA) in patients with septic shock: a multicenter randomised controlled clinical trial. BMJ Open. 2014 Jan 8;4(1):e003536. doi: 10.1136/bmjopen-2013-003536.
Results Reference
result
PubMed Identifier
27406647
Citation
Colomina-Climent F, Gimenez-Esparza C, Portillo-Requena C, Allegue-Gallego JM, Galindo-Martinez M, Molla-Jimenez C, Anton-Pascual JL, Rodriguez-Serra M, Martin-Ruiz JL, Fernandez-Arroyo PJ, Blasco-Ciscar EM, Canovas-Robles J, Herrera-Murillo M, Gonzalez-Hernandez E, Sanchez-Moran F, Solera-Suarez M, Torres-Tortajada J, Nunez-Martinez JM, Martin-Langerwerf D, Herrero-Gutierrez E, Sebastian-Munoz I, Palazon-Bru A, Gil-Guillen VF. Mortality Reduction in Septic Shock by Plasma Adsorption (ROMPA): a protocol for a randomised clinical trial. BMJ Open. 2016 Jul 12;6(7):e011856. doi: 10.1136/bmjopen-2016-011856.
Results Reference
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PubMed Identifier
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Citation
Franchi M, Giacalone M, Traupe I, Rago R, Baldi G, Giunta F, Forfori F. Coupled plasma filtration adsorption improves hemodynamics in septic shock. J Crit Care. 2016 Jun;33:100-5. doi: 10.1016/j.jcrc.2016.02.005. Epub 2016 Feb 15.
Results Reference
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Citation
Hazzard I, Jones S, Quinn T. Coupled plasma haemofiltration filtration in severe sepsis: systematic review and meta-analysis. J R Army Med Corps. 2015 Dec;161 Suppl 1:i17-i22. doi: 10.1136/jramc-2015-000552.
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Yaroustovsky M, Abramyan M, Krotenko N, Popov D, Plyushch M, Rogalskaya E. A pilot study of selective lipopolysaccharide adsorption and coupled plasma filtration and adsorption in adult patients with severe sepsis. Blood Purif. 2015;39(1-3):210-217. doi: 10.1159/000371754.
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Citation
Zhou N, Li J, Zhang Y, Lu J, Chen E, Du W, Wang J, Pan X, Zhu D, Yang Y, Chen Y, Cao H, Li L. Efficacy of coupled low-volume plasma exchange with plasma filtration adsorption in treating pigs with acute liver failure: A randomised study. J Hepatol. 2015 Aug;63(2):378-87. doi: 10.1016/j.jhep.2015.03.018. Epub 2015 Mar 24.
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Results Reference
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Therapeutic Plasma Exchange Adsorption Diafiltration
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