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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03866083
• Other study ID #: ILBS-Sepsis-20
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: March 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Rakhi Maiwall, DM
• Phone: 01146300000
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Extracorporeal Cytokine hemadsorption therapy
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.
• Standard Medical Treatment
Standard Medical Treatment

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reversal of shock in both groups		72 hours
Secondary	Mortality in both groups		28 days
Secondary	Duration of mechanical ventilation in both groups		3 months
Secondary	Number of days in Intensive Care Unit stay in both groups		3 months
Secondary	Reversal of Acute Kidney Injury		5 days
Secondary	Lactate clearance in both groups		1 day