Therapeutic Plasma Exchange Adsorption Diafiltration

NCT03589378 | Unknown DMC

• 2 other identifiers: SZLY201700720173357201815
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 12

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.

Conditions

Septic Shock; Multiple Organ Dysfunction Syndrome

Outcome Measures

Primary Outcomes (1)

• All-cause mortality within 28 days after randomization

  efficacy

  28 days after randomization

Secondary Outcomes (2)

• All-cause mortality within 90 days from randomization

  90 days from randomization

• free hours of vasoactive drugs from randomization

  14 days after randomization

Study Arms (2)

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.

Procedure: PEAF

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.

Interventions

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.

PEAF

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenzhen Second People's Hospital: lead

Study Sites (12)

Dongguan Fifth People's Hospital (Taiping Hospital)

Dongguan, Guangdong, 511761, China

NOT YET RECRUITING

Guangzhou General Hospital of Guangzhou Military Region

Guangzhou, Guangdong, 510010, China

NOT YET RECRUITING

School of Public Health, Southern Medical University

Guangzhou, Guangdong, 510515, China

NOT YET RECRUITING

Shenzhen Luohu People's hospitial

Shenzhen, Guangdong, 518001, China

NOT YET RECRUITING

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

NOT YET RECRUITING

The eighth affiliated hospital, Sun Yat-Sen university

Shenzhen, Guangdong, 518033, China

NOT YET RECRUITING

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

NOT YET RECRUITING

Shenzhen Sixth People's Hospital (Nanshan Hospital)

Shenzhen, Guangdong, 518052, China

NOT YET RECRUITING

Affiliated Baoan Hospital of Shenzhen, Southern Medical University (People' hospital of Baoan District)

Shenzhen, Guangdong, 518101, China

NOT YET RECRUITING

Shenzhen Longgang Central Hospital

Shenzhen, Guangdong, 518116, China

NOT YET RECRUITING

Shenzhen hospital of southern medicial university

Shenzhen, Guangdong, China

NOT YET RECRUITING

Shenzhen Second People's Hospital

Shenzhen, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 27322218 BACKGROUND

• 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.

  PMID: 24401721 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.

  PMID: 27406647 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.

  PMID: 26975736 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.

  PMID: 26621809 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.

  PMID: 25765778 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.

  PMID: 25814048 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.

  PMID: 24777037 RESULT

MeSH Terms

Conditions

Shock, Septic; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Ming Wu, MD

  Shenzhen Second People's Hospita

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Wu, MD

CONTACT

+86-0755-83366388; boshiyy@126.com

Yongwen Feng

CONTACT

+86-0755-83366388; fengyongwen2008@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a Multicenter,Randomized and Controlled Clinical Trial

Study Record Dates

• First Submitted: April 22, 2018
• First Posted: July 17, 2018
• Study Start: August 13, 2018
• Primary Completion: December 31, 2019
• Study Completion: September 30, 2020
• Last Updated: August 29, 2018

Record last verified: 2018-08

Locations

CN (12)