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

NCT03866083 | Unknown

• 1 other identifier: ILBS-Sepsis-20
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• Reversal of shock in both groups

  72 hours

Secondary Outcomes (5)

• 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

Study Arms (2)

Extracorporeal Cytokine hemadsorption therapy

EXPERIMENTAL

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; Drug: Standard Medical Treatment

Stadard Medical treatment

ACTIVE COMPARATOR

Stadard Medical treatment

Drug: Standard Medical Treatment

Interventions

Extracorporeal Cytokine hemadsorption therapy DRUG

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.

Extracorporeal Cytokine hemadsorption therapy

Standard Medical Treatment DRUG

Standard Medical Treatment

Extracorporeal Cytokine hemadsorption therapy; Stadard Medical treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Critically ill cirrhotics with early onset septic shock (\<24 hours) with norepinephrine of more than 10 ug/min and lactate \>4 mmol/L.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Dr Rakhi Maiwall, DM

CONTACT

01146300000

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 7, 2019
• Study Start: March 1, 2019
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: May 1, 2019

Record last verified: 2019-03

Locations

IN (1)