Safety and Efficacy of Extracorporeal Cytokine Hemoadsorption in Septic Shock in Critically Ill Cirrhotics

Study Overview
=================
Brief Summary
-----------------
Patients with septic shock would be screened. Following this, patients meeting the inclusion and exclusion criteria will be screened and randomized to the two treatment groups. Standard criteria will be considered to define refractoriness to fluids. In all patients, baseline endotoxin activity assay and blood and urine sample will be stored for looking at the effect of therapy on these factors. Septic shock would be defined as clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP>=65 mm of Hg and having a serum lactate >2 mmol/L despite adequate volume resuscitation. Patients assigned to the treatment arm and who do not already have access for dialysis will have a standard hemodialysis catheter inserted in one of the femoral veins by the physician. Hemoperfusion will be carried out for one session within 12 hours for all randomized patient using the adsorption columns for Jianfan Biotechnology Co., Zhuhai, China). The hemoperfusion apparatus will be connected in front of the hemodialyzer in series. The procedure would be done for 2 hours without use of heparin with use of normal saline for pipeline flushing. In patients who also require hemodialysis the dialysis would subsequently be continued. Subsequent sessions of therapy would be done for patients (if required).

Official Title
-----------------
Safety and Efficacy of Extracorporeal Cytokine Hemoadsorption in Septic Shock in Critically Ill Cirrhotics -A Prospective Randomized Controlled Trial

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Drug: Extracorporeal Cytokine hemadsorption therapy
* Drug: Standard Medical Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Critically ill cirrhotics with early onset septic shock (<24 hours) with norepinephrine of more than 10 ug/min and lactate >4 mmol/L. Exclusion Criteria: Patients with age less than 18 years Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD) Severe coagulopathy platelets <20,000 and INR >5 Active Bleed (Mucosal or variceal) Pregnancy Chronic kidney disease Extremely moribund patients with an expected life expectancy of less than 24 hours Failure to give informed consent from family members. Hemodynamic instability requiring very high dose of vasopressors, late presentation or spontaneous reversal of shock Patient enrolled in other clinical trials

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extracorporeal Cytokine hemadsorption therapy<br>Hemoperfusion will be carried out for one session within 12 hours for all randomized patient using the adsorption columns for Jianfan Biotechnology Co., Zhuhai, China). The hemoperfusion apparatus will be connected in front of the hemodialyzer in series. | Drug: Extracorporeal Cytokine hemadsorption therapy<br>* Hemoperfusion will be carried out for one session within 12 hours for all randomized patient using the adsorption columns for Jianfan Biotechnology Co., Zhuhai, China). The hemoperfusion apparatus will be connected in front of the hemodialyzer in series.<br>Drug: Standard Medical Treatment<br>* Standard Medical Treatment<br>|
| Active Comparator: Stadard Medical treatment<br>Stadard Medical treatment | Drug: Standard Medical Treatment<br>* Standard Medical Treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reversal of shock in both groups |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality in both groups |  | 28 days | 
| Duration of mechanical ventilation in both groups |  | 3 months | 
| Number of days in Intensive Care Unit stay in both groups |  | 3 months | 
| Reversal of Acute Kidney Injury |  | 5 days | 
| Lactate clearance in both groups |  | 1 day |