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PEAF: Therapeutic Plasma Exchange Adsorption Diafiltration

Sponsor
Shenzhen Second People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03589378
Collaborator
(none)
168
Enrollment
12
Locations
2
Arms
25.6
Anticipated Duration (Months)
14
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: PEAF
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
168 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
a Multicenter,Randomized and Controlled Clinical Triala Multicenter,Randomized and Controlled Clinical Trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of PEAF for Septic Shock With Multiple Organ Dysfunction Syndrome in ICU:A Multicenter,Open-Parallelled ,Randomized and Controlled Clinical Trial
Actual Study Start Date :
Aug 13, 2018
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Sep 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. All-cause mortality within 28 days after randomization [28 days after randomization]

    efficacy

Secondary Outcome Measures

  1. All-cause mortality within 90 days from randomization [90 days from randomization]

    efficacy

  2. free hours of vasoactive drugs from randomization [14 days after randomization]

    efficacy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dongguan Fifth People's Hospital (Taiping Hospital) Dongguan Guang Dong China 511761
2 Guangzhou General Hospital of Guangzhou Military Region Guangzhou Guang Dong China 510010
3 School of Public Health, Southern Medical University Guangzhou Guang Dong China 510515
4 Shenzhen Luohu People's hospitial Shenzhen Guang Dong China 518001
5 Shenzhen People's Hospital Shenzhen Guang Dong China 518020
6 The eighth affiliated hospital, Sun Yat-Sen university Shenzhen Guang Dong China 518033
7 Peking University Shenzhen Hospital Shenzhen Guang Dong China 518036
8 Shenzhen Sixth People's Hospital (Nanshan Hospital) ShenZhen Guang Dong China 518052
9 Affiliated Baoan Hospital of Shenzhen, Southern Medical University (People' hospital of Baoan District) Shenzhen Guang Dong China 518101
10 Shenzhen Longgang Central Hospital Shenzhen Guang Dong China 518116
11 Shenzhen hospital of southern medicial university Shenzhen Guang Dong China
12 Shenzhen Second People's Hospital Shenzhen China

Sponsors and Collaborators

  • Shenzhen Second People's Hospital

Investigators

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

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Shenzhen Second People's Hospital
ClinicalTrials.gov Identifier:
NCT03589378
Other Study ID Numbers:
  • SZLY2017007
  • 20173357201815
First Posted:
Jul 17, 2018
Last Update Posted:
Aug 29, 2018
Last Verified:
Aug 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Shock, Septic
Syndrome
Multiple Organ Failure

Study Results

No Results Posted as of Aug 29, 2018