Clinical trial NCT03589378: Therapeutic Plasma Exchange Adsorption Diafiltration
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
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Shock
Multiple Organ Dysfunction Syndrome
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a Multicenter,Randomized and Controlled Clinical Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age, gender: 18-75 years old, male or female;
2. basic conditions: 20 ≤ APACHE II score ≤ 35 points and 10 ≤ Sequential Organ Failure Assessment(SOFA)≤ 18 points;
3. 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:

1. can not remove the cause (surgical patients refused surgery, pan drug resistant infection without drug use)
2. Allergic to AMPLYA™ series
3. Presence of relative or absolute contraindications to PFA
4. MODS caused by severe liver disease
5. malignant tumors
6. Chronic end-stage disease (predicted to survive no more than one month)
7. Maternal and possibly pregnant women
8. participated in drug clinical trials within three months
9. Admission from an other ICU where the patient remained for more than 24 hours

Primary outcomes:
measure: All-cause mortality within 28 days after randomization
timeFrame: 28 days after randomization
Secondary outcomes:
measure: All-cause mortality within 90 days from randomization
timeFrame: 90 days from randomization
measure: free hours of vasoactive drugs from randomization
timeFrame: 14 days after randomization
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Dongguan Fifth People's Hospital (Taiping Hospital)
state: Guang Dong
city: Guangzhou
country: China
facility: Guangzhou General Hospital of Guangzhou Military Region
state: Guang Dong
city: Guangzhou
country: China
facility: School of Public Health, Southern Medical University
state: Guang Dong
city: Shenzhen
country: China
facility: Shenzhen Luohu People's hospitial
state: Guang Dong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guang Dong
city: Shenzhen
country: China
facility: The eighth affiliated hospital, Sun Yat-Sen university
state: Guang Dong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guang Dong
city: ShenZhen
country: China
facility: Shenzhen Sixth People's Hospital (Nanshan Hospital)
state: Guang Dong
city: Shenzhen
country: China
facility: Affiliated Baoan Hospital of Shenzhen, Southern Medical University (People' hospital of Baoan District)
state: Guang Dong
city: Shenzhen
country: China
facility: Shenzhen Longgang Central Hospital
state: Guang Dong
city: Shenzhen
country: China
facility: Shenzhen hospital of southern medicial university
state: Guang Dong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
Study officials:
affiliation: Shenzhen Second People's Hospita
name: Ming Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: 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.
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.
citation: 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.