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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03866083
Enrollment
50
Registered
2019-03-07
Start date
2019-03-01
Completion date
2019-06-30
Last updated
2019-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

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).

Interventions

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.

DRUGStandard Medical Treatment

Standard Medical Treatment

Sponsors

Institute of Liver and Biliary Sciences, India
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Reversal of shock in both groups72 hours

Secondary

MeasureTime frame
Mortality in both groups28 days
Duration of mechanical ventilation in both groups3 months
Number of days in Intensive Care Unit stay in both groups3 months
Reversal of Acute Kidney Injury5 days
Lactate clearance in both groups1 day

Countries

India

Contacts

Primary ContactDr Rakhi Maiwall, DM
01146300000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026