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

• ClinicalTrials.gov Identifier: NCT03866083
• Recruitment Status: Unknown
• First Posted: March 7, 2019
• Last Update Posted: May 1, 2019
• Sponsor: Institute of Liver and Biliary Sciences, India
• Information provided by (Responsible Party): Institute of Liver and Biliary Sciences, India

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Septic Shock	Drug: Extracorporeal Cytokine hemadsorption therapy; Drug: Standard Medical Treatment	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Extracorporeal Cytokine Hemoadsorption in Septic Shock in Critically Ill Cirrhotics -A Prospective Randomized Controlled Trial
• Actual Study Start Date: March 1, 2019
• Estimated Primary Completion Date: June 30, 2019
• Estimated Study Completion Date: June 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.; Drug: Standard Medical Treatment; Standard Medical Treatment
Active Comparator: Stadard Medical treatment; Stadard Medical treatment	Drug: Standard Medical Treatment; Standard Medical Treatment

Outcome Measures

Primary Outcome Measures :

1. Reversal of shock in both groups [ Time Frame: 72 hours ]

Secondary Outcome Measures :

1. Mortality in both groups [ Time Frame: 28 days ]
2. Duration of mechanical ventilation in both groups [ Time Frame: 3 months ]
3. Number of days in Intensive Care Unit stay in both groups [ Time Frame: 3 months ]
4. Reversal of Acute Kidney Injury [ Time Frame: 5 days ]
5. Lactate clearance in both groups [ Time Frame: 1 day ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Dr Rakhi Maiwall, DM; 01146300000

Locations

India

Institute of Liver & Biliary Sciences; Recruiting

New Delhi, Delhi, India, 110070

Contact: Dr Rakhi Maiwall, DM 01146300000

Sponsors and Collaborators

Institute of Liver and Biliary Sciences, India

More Information

• Responsible Party: Institute of Liver and Biliary Sciences, India
• ClinicalTrials.gov Identifier: NCT03866083
• Other Study ID Numbers: ILBS-Sepsis-20
• First Posted: March 7, 2019
• Last Update Posted: May 1, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Shock, Septic; Shock; Pathologic Processes; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation