Septic ShockPEAFNCT03589378
Therapeutic Plasma Exchange Adsorption Diafiltration
A study testing PEAF in people with Septic Shock and Multiple Organ Dysfunction Syndrome, run by Shenzhen Second People's Hospital at 12 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Septic Shock, Multiple Organ Dysfunction Syndrome
- What is being tested?
- PEAF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 12 sitesChina
- Study dates
- 13 Aug 2018to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites, 12 recruiting
- Not yet recruiting
Dongguan Fifth People's Hospital (Taiping Hospital)
Dongguan, Guangdong, 511761
Yi Chen, MD Ph.D, +86-0769-85010257, chenyi_icu@163.com
Yi Chen, MD Ph.D
- Not yet recruiting
Guangzhou General Hospital of Guangzhou Military Region
Guangzhou, Guangdong, 510010
Huansheng Tong, MD Ph.D, +86-020-88653353, fimmuths@163.com
Huansheng Tong, MD PhD
- Not yet recruiting
School of Public Health, Southern Medical University
Guangzhou, Guangdong, 510515
Shengli Zhang, Ph.D, +86-020-61648311, asl0418@126.com
Shengli Zhang, Ph.D
- Not yet recruiting
Shenzhen Luohu People's hospitial
Shenzhen, Guangdong, 518001
Mian Peng, MD, +86-0755-25650005, 1031994903@qq.com
Mian Peng, MD
- Not yet recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
Huaisheng Chen, MD, +86-0755-25533018, sunshinic@hotmail.com
Huaisheng Chen, MD
- Not yet recruiting
The eighth affiliated hospital, Sun Yat-Sen university
Shenzhen, Guangdong, 518033
Hao LI, MD, +86-0755-83982222, snapzero@163.com
Hao LI, MD
- Not yet recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Lei Huang, MD, +86-0755-83923333, hl0248@outlook.com
Lei Huang, MD
- Not yet recruiting
Shenzhen Sixth People's Hospital (Nanshan Hospital)
Shenzhen, Guangdong, 518052
JING lan Wu, MD, +86-0755-26553111, doctorwu99@126.com
JING lan Wu, MD
- Not yet recruiting
Affiliated Baoan Hospital of Shenzhen, Southern Medical University (People' hospital of Baoan District)
Shenzhen, Guangdong, 518101
Baojun Yu, MD, +86-0755-27788311, ybjhb@163.com
Baojun Yu, MD
- Not yet recruiting
Shenzhen Longgang Central Hospital
Shenzhen, Guangdong, 518116
Ronglin Chen, MD, +86-0755-84806933, 13510156528@126.com
Ronglin Chen, MD
- Not yet recruiting
Shenzhen hospital of southern medicial university
Shenzhen, Guangdong
Yong Liu, MD, +86-0755-23329999, liuyongjoy@hotmail.com
Yong Liu, MD
- Recruiting
Shenzhen Second People's Hospital
Shenzhen
Ming Wu, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Septic Shock, Multiple Organ Dysfunction Syndrome
- Being tested
- PEAF
- Medical subject headings
- Shock, Septic, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEAFProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality within 28 days after randomization
efficacy
Measured: 28 days after randomization
Secondary outcomes (2)
All-cause mortality within 90 days from randomization
efficacy
Measured: 90 days from randomization
free hours of vasoactive drugs from randomization
efficacy
Measured: 14 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start13 Aug 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a Multicenter,Randomized and Controlled Clinical Trial
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Wu, MD, Principal investigator, Shenzhen Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589378
- Sponsor's protocol ID
- SZLY2017007
- Other IDs
- 20173357201815
- Acronym
- PEAF
- Status last verified
- Aug 2018
- First submitted
- 22 Apr 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27322218Livigni 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.
PubMed 24401721Colomina-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.
PubMed 27406647Franchi 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.
PubMed 26975736Hazzard 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.
PubMed 26621809Yaroustovsky 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.
PubMed 25765778Zhou 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.
PubMed 25814048Berlot 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.
PubMed 24777037
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of PEAF for Septic Shock With Multiple Organ Dysfunction Syndrome in ICU:A Multicenter,Open-Parallelled ,Randomized and Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03589378
- Acronym / sponsor ID
- PEAF / SZLY2017007
- Conditions
- Septic Shock, Multiple Organ Dysfunction Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a Multicenter,Randomized and Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| PEAF | Experimental | Procedure: PEAFIntervention 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEAFPEAF 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. | Procedure or surgery | PEAF |
Primary outcome
All-cause mortality within 28 days after randomization
Time frame: 28 days after randomization
efficacy
2 secondary outcomes
All-cause mortality within 90 days from randomization
Time frame: 90 days from randomization
free hours of vasoactive drugs from randomization
Time frame: 14 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Background: PubMed 27322218Schwartz 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.
- Results publication: PubMed 24401721Livigni 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.
- Results publication: PubMed 27406647Colomina-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.
- Results publication: PubMed 26975736Franchi 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.
- Results publication: PubMed 26621809Hazzard 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.
- Results publication: PubMed 25765778Yaroustovsky 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.
- Results publication: PubMed 25814048Zhou 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.
- Results publication: PubMed 24777037Berlot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Wu, MD principal investigator
Shenzhen Second People's Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEAF in people with Septic Shock and Multiple Organ Dysfunction Syndrome, run by Shenzhen Second People's Hospital at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Wu, MD (+86-0755-83366388, boshiyy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality within 28 days after randomization (time frame: 28 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03589378, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.