Therapeutic Plasma Exchange Adsorption Diafiltration

Septic Shock Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03589378
• Other study ID #: SZLY2017007
• Secondary ID: 20173357201815
• Status: Recruiting
• Phase: N/A
• Start date: August 13, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: August 2018
• Source: Shenzhen Second People's Hospital
• Contact: Ming Wu, MD
• Phone: +86-0755-83366388
• Email: boshiyy[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: September 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Organ Dysfunction Syndrome
• Multiple Organ Failure
• Septic Shock
• Shock, Septic
• Syndrome

Intervention

Procedure:
• PEAF
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.

Locations

Country	Name	City	State
China	Dongguan Fifth People's Hospital (Taiping Hospital)	Dongguan	Guang Dong
China	Guangzhou General Hospital of Guangzhou Military Region	Guangzhou	Guang Dong
China	School of Public Health, Southern Medical University	Guangzhou	Guang Dong
China	Affiliated Baoan Hospital of Shenzhen, Southern Medical University (People' hospital of Baoan District)	Shenzhen	Guang Dong
China	Peking University Shenzhen Hospital	Shenzhen	Guang Dong
China	Shenzhen hospital of southern medicial university	Shenzhen	Guang Dong
China	Shenzhen Longgang Central Hospital	Shenzhen	Guang Dong
China	Shenzhen Luohu People's hospitial	Shenzhen	Guang Dong
China	Shenzhen People's Hospital	Shenzhen	Guang Dong
China	Shenzhen Second People's Hospital	Shenzhen
China	Shenzhen Sixth People's Hospital (Nanshan Hospital)	ShenZhen	Guang Dong
China	The eighth affiliated hospital, Sun Yat-Sen university	Shenzhen	Guang Dong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

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 pla — View Citation

Colomina-Climent F, Giménez-Esparza C, Portillo-Requena C, Allegue-Gallego JM, Galindo-Martínez M, Mollà-Jiménez C, Antón-Pascual JL, Rodríguez-Serra M, Martín-Ruíz JL, Fernández-Arroyo PJ, Blasco-Císcar EM, Cánovas-Robles J, Herrera-Murillo M, González-H — View 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. — View 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. Review. — View 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 — View 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. Review. — View 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):210-7. — View 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 A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality within 28 days after randomization	efficacy	28 days after randomization
Secondary	All-cause mortality within 90 days from randomization	efficacy	90 days from randomization
Secondary	free hours of vasoactive drugs from randomization	efficacy	14 days after randomization