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

Institute of Liver and Biliary Sciences, India

Status: Unknown

Conditions: Septic Shock

Treatments: Drug: Extracorporeal Cytokine hemadsorption therapy; Drug: Standard Medical Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03866083

ILBS-Sepsis-20

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Extracorporeal Cytokine hemadsorption therapy

Experimental group

Description:

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.

Treatment:

Drug: Standard Medical Treatment

Drug: Extracorporeal Cytokine hemadsorption therapy

Stadard Medical treatment

Active Comparator group

Description:

Stadard Medical treatment

Treatment:

Drug: Standard Medical Treatment