Therapeutic Plasma Exchange Adsorption Diafiltration (PEAF)

August 27, 2018 updated by: Shenzhen Second People's Hospital

Efficacy of PEAF for Septic Shock With Multiple Organ Dysfunction Syndrome in ICU:A Multicenter,Open-Parallelled ,Randomized and Controlled Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shenzhen, China
        • Recruiting
        • Shenzhen Second People's Hospital
        • Contact:
          • Ming Wu, MD
    • Guang Dong
      • Dongguan, Guang Dong, China, 511761
        • Not yet recruiting
        • Dongguan Fifth People's Hospital (Taiping Hospital)
        • Contact:
        • Principal Investigator:
          • Yi Chen, MD Ph.D
      • Guangzhou, Guang Dong, China, 510010
        • Not yet recruiting
        • Guangzhou General Hospital of Guangzhou Military Region
        • Contact:
          • Huansheng Tong, MD Ph.D
          • Phone Number: +86-020-88653353
          • Email: fimmuths@163.com
        • Principal Investigator:
          • Huansheng Tong, MD PhD
      • Guangzhou, Guang Dong, China, 510515
        • Not yet recruiting
        • School of Public Health, Southern Medical University
        • Contact:
          • Shengli Zhang, Ph.D
          • Phone Number: +86-020-61648311
          • Email: asl0418@126.com
        • Principal Investigator:
          • Shengli Zhang, Ph.D
      • ShenZhen, Guang Dong, China, 518052
        • Not yet recruiting
        • Shenzhen Sixth People's Hospital (Nanshan Hospital)
        • Contact:
        • Principal Investigator:
          • JING lan Wu, MD
      • Shenzhen, Guang Dong, China, 518001
        • Not yet recruiting
        • Shenzhen Luohu People's hospitial
        • Contact:
        • Principal Investigator:
          • Mian Peng, MD
      • Shenzhen, Guang Dong, China, 518020
        • Not yet recruiting
        • ShenZhen People's Hospital
        • Contact:
        • Principal Investigator:
          • Huaisheng Chen, MD
      • Shenzhen, Guang Dong, China, 518033
        • Not yet recruiting
        • The Eighth Affiliated Hospital, Sun Yat-sen University
        • Contact:
      • Shenzhen, Guang Dong, China, 518036
        • Not yet recruiting
        • Peking University Shenzhen Hospital
        • Contact:
        • Principal Investigator:
          • Lei Huang, MD
      • Shenzhen, Guang Dong, China, 518101
        • Not yet recruiting
        • Affiliated Baoan Hospital of Shenzhen, Southern Medical University (People' hospital of Baoan District)
        • Contact:
          • Baojun Yu, MD
          • Phone Number: +86-0755-27788311
          • Email: ybjhb@163.com
        • Principal Investigator:
          • Baojun Yu, MD
      • Shenzhen, Guang Dong, China, 518116
        • Not yet recruiting
        • Shenzhen Longgang Central Hospital
        • Contact:
        • Principal Investigator:
          • Ronglin Chen, MD
      • Shenzhen, Guang Dong, China
        • Not yet recruiting
        • Shenzhen hospital of southern medicial university
        • Principal Investigator:
          • Yong Liu, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PEAF
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
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.
NO_INTERVENTION: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality within 28 days after randomization
Time Frame: 28 days after randomization
efficacy
28 days after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality within 90 days from randomization
Time Frame: 90 days from randomization
efficacy
90 days from randomization
free hours of vasoactive drugs from randomization
Time Frame: 14 days after randomization
efficacy
14 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Second People's Hospital

Investigators

  • Principal Investigator: Ming Wu, MD, Shenzhen Second People's Hospita

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 13, 2018

Primary Completion (ANTICIPATED)

December 31, 2019

Study Completion (ANTICIPATED)

September 30, 2020

Study Registration Dates

First Submitted

April 22, 2018

First Submitted That Met QC Criteria

July 4, 2018

First Posted (ACTUAL)

July 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SZLY2017007
  • 20173357201815 (OTHER_GRANT: ShenZhen Second People's Hospital)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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