Safety and Efficacy of Extracorporeal Cytokine Hemoadsorption in Septic Shock in Critically Ill Cirrhotics
Status:
Unknown status
Trial end date:
2019-06-30
Target enrollment:
Participant gender:
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).