Multiple Organ Dysfunction Syndrome, Septic Shock
Conditions
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.
Interventions
PROCEDUREPEAF
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.
Sponsors
Shenzhen Second People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
a Multicenter,Randomized and Controlled Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality within 28 days after randomization | 28 days after randomization | efficacy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality within 90 days from randomization | 90 days from randomization | efficacy |
| free hours of vasoactive drugs from randomization | 14 days after randomization | efficacy |
Countries
China
Contacts
Primary ContactMing Wu, MD
Backup ContactYongwen Feng
Outcome results
None listed