Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 20173357201815 | Other Grant/Funding Number | ShenZhen Second People's Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEAF | Experimental | 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. |
|
| Control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEAF | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality within 28 days after randomization | efficacy | 28 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality within 90 days from randomization | efficacy | 90 days from randomization |
| free hours of vasoactive drugs from randomization | efficacy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Wu, MD | Contact | +86-0755-83366388 | boshiyy@126.com | |
| Yongwen Feng | Contact | +86-0755-83366388 | fengyongwen2008@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ming Wu, MD | Shenzhen Second People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguan Fifth People's Hospital (Taiping Hospital) | Not yet recruiting | Dongguan | Guangdong | 511761 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27322218 | Background | 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. | |
| 24401721 |
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 18, 2018 | Jun 18, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 18, 2018 | Jun 18, 2018 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D009102 | Multiple Organ Failure |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
Not provided
Not provided
a Multicenter,Randomized and Controlled Clinical Trial
Not provided
Not provided
Not provided
Not provided
|
| 14 days after randomization |
| Guangzhou General Hospital of Guangzhou Military Region | Not yet recruiting | Guangzhou | Guangdong | 510010 | China |
|
| School of Public Health, Southern Medical University | Not yet recruiting | Guangzhou | Guangdong | 510515 | China |
|
| Shenzhen Luohu People's hospitial | Not yet recruiting | Shenzhen | Guangdong | 518001 | China |
|
| Shenzhen People's Hospital | Not yet recruiting | Shenzhen | Guangdong | 518020 | China |
|
| The eighth affiliated hospital, Sun Yat-Sen university | Not yet recruiting | Shenzhen | Guangdong | 518033 | China |
|
| Peking University Shenzhen Hospital | Not yet recruiting | Shenzhen | Guangdong | 518036 | China |
|
| Shenzhen Sixth People's Hospital (Nanshan Hospital) | Not yet recruiting | Shenzhen | Guangdong | 518052 | China |
|
| Affiliated Baoan Hospital of Shenzhen, Southern Medical University (People' hospital of Baoan District) | Not yet recruiting | Shenzhen | Guangdong | 518101 | China |
|
| Shenzhen Longgang Central Hospital | Not yet recruiting | Shenzhen | Guangdong | 518116 | China |
|
| Shenzhen hospital of southern medicial university | Not yet recruiting | Shenzhen | Guangdong | China |
|
| Shenzhen Second People's Hospital | Recruiting | Shenzhen | China |
|
| 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. |
| 27406647 | Result | 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. |
| 26975736 | Result | 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. |
| 26621809 | Result | 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. |
| 25765778 | Result | 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. |
| 25814048 | Result | 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. |
| 24777037 | Result | Berlot G, Agbedjro A, Tomasini A, Bianco F, Gerini U, Viviani M, Giudici F. Effects of the volume of processed plasma on the outcome, arterial pressure and blood procalcitonin levels in patients with severe sepsis and septic shock treated with coupled plasma filtration and adsorption. Blood Purif. 2014;37(2):146-51. doi: 10.1159/000360268. Epub 2014 Apr 26. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |