Therapeutic Plasma Exchange Adsorption Diafiltration

Not Applicable

• Conditions: Septic Shock; Multiple Organ Dysfunction Syndrome
• Interventions: Procedure: PEAF

• Registration Number: NCT03589378
• Lead Sponsor: Shenzhen Second People's Hospital

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.

Study Timeline

• Study First Submitted: 2018-04-22
• Study First Submitted QC: 2018-07-04
• Study First Posted: 2018-07-17
• Status Verified: 2018-08
• Study Start: 2018-08-13
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-29
• Primary Completion: 2019-12-31
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 168

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEAF	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.

Primary Outcome Measures

Name	Time	Method
All-cause mortality within 28 days after randomization	28 days after randomization	efficacy

Secondary Outcome Measures

Name	Time	Method
free hours of vasoactive drugs from randomization	14 days after randomization	efficacy
All-cause mortality within 90 days from randomization	90 days from randomization	efficacy

Trial Locations

Locations (12)

Guangzhou General Hospital of Guangzhou Military Region; 🇨🇳 Guangzhou, Guang Dong, China

School of Public Health, Southern Medical University; 🇨🇳 Guangzhou, Guang Dong, China

Shenzhen People's Hospital; 🇨🇳 Shenzhen, Guang Dong, China

Dongguan Fifth People's Hospital (Taiping Hospital); 🇨🇳 Dongguan, Guang Dong, China

Shenzhen Luohu People's hospitial; 🇨🇳 Shenzhen, Guang Dong, China

Shenzhen Sixth People's Hospital (Nanshan Hospital); 🇨🇳 ShenZhen, Guang Dong, China

Affiliated Baoan Hospital of Shenzhen, Southern Medical University (People' hospital of Baoan District); 🇨🇳 Shenzhen, Guang Dong, China

Shenzhen Longgang Central Hospital; 🇨🇳 Shenzhen, Guang Dong, China

Shenzhen hospital of southern medicial university; 🇨🇳 Shenzhen, Guang Dong, China

The eighth affiliated hospital, Sun Yat-Sen university; 🇨🇳 Shenzhen, Guang Dong, China

Peking University Shenzhen Hospital; 🇨🇳 Shenzhen, Guang Dong, China

Shenzhen Second People's Hospital; 🇨🇳 Shenzhen, China