Pro-inflammatory Cytokines Profile and Mortality Rate of Critically Ill Septic Patients Following Plasmapheresis
NCT ID: NCT01249222
Last Updated: 2010-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
27 participants
INTERVENTIONAL
2008-11-30
2011-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Researchers have done several attempts to clarify the efficacy of plasmapheresis in sepsis treatment. However because of inconsistent results, routine use of this procedure in patients with severe sepsis remains controversial.
The aim of the present survey is to determine the effect of plasmapheresis on plasma levels of main pro-inflammatory cytokines and evaluate its therapeutic efficacy in improvement of outcome and treatment of severe sepsis.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Inclusion criteria:
A: At least 3 of SIRS criteria;
1. 36\> Tem\> 38 ◦c
2. HR\>90 bpm (without medication)
3. RR\>20 bpm or PaCo2≤ 32 on mechanical ventilation
4. WBC\<4000 or \>12000 or \> 10% immature neutrophil
B: Documented diagnosis of sepsis (separation organism from blood, urine, CSF, secretions such as trachea and sore) or strong suspect for infection with at least one of following:
1. WBC in sterile area,
2. Perforated viscera,
3. Radiological evidences of pneumonia,
4. High risk of infection such as cholangitis. Severity of disease is appointed with APACHE II (on result of laboratories in last 24 hours)
Exclusion criteria:
1. Pass more than 24 hours from diagnosis of sepsis.
2. High likelihood of mortality (renal failure, hepatic encephalopathy, ….) or imminent death(APACHE II score \>25)
3. Pregnant or lactescent woman
4. 16 \> age years old
5. No satisfaction of patient
Treatments of S group include:
1. Early goal - directed resuscitation
2. Appropriate diagnostic studies prior to antibiotics
3. Early broad - spectrum antibiotics
4. Narrowing antibiotic therapy based on microbial therapy and clinical data
5. Source control
6. Stress dose steroids for septic shock
7. Target Hb values of 7-9 g/dl in absence of coronary artery disease or acute hemorrhage
8. Lung protective ventilation for ALI/ARDS
9. Avoidance of Neuromuscular blockade
10. Maintenance of blood glucose \< 150mg/dl
11. DVT/stress ulcer prophylaxis
In plasmapheresis (P) group, plasmapheresis will add into conventional therapy which is mentioned above. volume of plasmapheresis is 20-40 ml/Kg with five time in a week (distance 24-48 hours) that will do with speed of 60-120 ml/min through of central venous catheter.
Steps of plasmapheresis:
1. calculation of plasma volume
2. PT, PTT, Plt before and after plasmapheresis
3. Replacement plasma with albumin 20% and/or normal saline
4. Check of serum calcium before and after plasmapheresis. Injection of calcium gluconate 10%.
5. Stop of all of drugs (except vasopressor)
6. Cardiovascular monitoring during plasmapheresis
7. Infusion of heparin 500 u/h Demographic characters of patients (age, sex, weight, BMI) will record. Central venous, arterial line and Foley catheter will insert. For all of patients will do follow assays daily: CVP, BP, ABG, BUN, Cr, Na, K, CBC, PLT, PT, PTT, U/A, P, Ca, Mg, Chest X Ray. LFT and Alb
Level of biomarkers evaluate at 1st, 3rd, 5th, 7th and 14th day of study. In P group, evaluation will do before and after of plasmapheresis. Biomarkers include:
1. TNF-α (early release cytokine)(plasma)
2. IL-1 (early release cytokine)(plasma)
3. IL-6 (pro \& anti-inflammatory cytokine)(plasma) Patient will evaluate for 14 days or until death. Patient's morbidity will record until 30 days.
Evaluation of morbidity will do by scoring systems:
* TISS score (Therapeutic intervention scoring system): for evaluation of severity of care.
* SOFA score (Sepsis- related organ function assessment): for evaluation of organ function.
* ADL score (Activities of daily living) Recorded information will analyze by t- test for quantitative variables and χ 2 square for qualitative variables, with α = 0/05.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
conventional treatment
plasmapheresis
plasmapheresis 5 times every 24-48 hours. the apheresis volume will be 30 ml/kg.
Plasmapheresis
plasmapheresis
Plasmapheresis was done every 24-48 hours and continues up to five times. Blood samples were collected 30 minutes before and after each session of plasmapheresis to determine sequential changes in plasma levels of IL-1β, IL-6 and TNF-α. During each exchange session a volume of 25-30 ml/kg bodyweight of patient's plasma was exchanged with equal volume of 20% human albumin diluted with normal saline solution. Before and after plasmapheresis, prothrombin time, activated partial thromboplastin time (aPTT), platelet count and serum calcium level were checked. calcium gluconate 10% (10 ml) was administered even if patient had normal serum calcium in order to prevent hypocalcaemia due to administration of citrate. All drugs except for vasopressors were stopped during procedure.
plasmapheresis
plasmapheresis 5 times every 24-48 hours. the apheresis volume will be 30 ml/kg.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
plasmapheresis
Plasmapheresis was done every 24-48 hours and continues up to five times. Blood samples were collected 30 minutes before and after each session of plasmapheresis to determine sequential changes in plasma levels of IL-1β, IL-6 and TNF-α. During each exchange session a volume of 25-30 ml/kg bodyweight of patient's plasma was exchanged with equal volume of 20% human albumin diluted with normal saline solution. Before and after plasmapheresis, prothrombin time, activated partial thromboplastin time (aPTT), platelet count and serum calcium level were checked. calcium gluconate 10% (10 ml) was administered even if patient had normal serum calcium in order to prevent hypocalcaemia due to administration of citrate. All drugs except for vasopressors were stopped during procedure.
plasmapheresis
plasmapheresis 5 times every 24-48 hours. the apheresis volume will be 30 ml/kg.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tehran University of Medical Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
PSRC
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mojtaba Mojtahedzadeh, Ph.D
Role: STUDY_CHAIR
1Department of Clinical Pharmacy, Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tehran University of Medical sciences, Imam hospital
Tehran, Tehran Province, Iran
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Mojtaba Mojtahedzadeh, Ph.D
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D-230-402
Identifier Type: -
Identifier Source: org_study_id