Health TrialsbyHealthPanel

Combination of Cytokine Hemosorption and High-volume Hemofiltration in Acute Pancreatitis

ConditionAcute Pancreatitis Without Necrosis or Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEfferon JSC

About this trial

Mortality from severe acute pancreatitis reaches 42%. The prognosis of acute pancreatitis is associated with the development of acute inflammatory response syndrome (SIRS) and multiple organ failure (MOF). Due to the lack of etiological therapy, the treatment of acute pancreatitis is predominantly symptomatic.

Severity and mortality are associated with early systemic inflammatory response syndrome (SIRS) and septic complications in the later stages of the disease.

In connection with a pronounced inflammatory reaction ("cytokine storm") in the early phase of endogenous intoxication of acute pancreatitis, a promising therapeutic approach is the extracorporeal removal of cytokines.

This prospective study intends to study the effect of hemoperfusion (Efferon CT) in combination with high-volume hemofiltration (HVHF) on the severity of symptoms of endogenous intoxication and indicators of organ dysfunction in acute pancreatitis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 18 to 75 years old,

Acute pancreatitis according to the Atlanta classification of OP (2012), without signs of infection,

Acute pancreatitis confirmed by tomography. Score according to the Modified CTSI Pancreatitis Severity Index: from 4 points and above,

No more than 3 days from the onset of an attack of acute pancreatitis,

Disqualifiers

Age over 75,

More than 3 days from the onset of an attack of acute pancreatitis,

An attack of acute pancreatitis, as an exacerbation of chronic pancreatitis.

Acute pancreatitis as a complication of a surgical operation,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Efferon CT

    Device

    Efferon CT (JSC Efferon, Moscow, RF) is a device for extracorporeal blood purification by direct hemoperfusion. Detoxification is carried out by sorption of cytokines and other products of endogenous intoxication with a molecular size of up to 55 kDa.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Baseline therapyNo intervention 0 interventions
Group B: Basic therapy + Efferon CT + HVHFExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Effect of the combined use of the Efferon CT device and HVHF on indicators of organ dysfunction

The value of indicators on the SOFA scale every 24 hours ± 1 hour from the start of hemoperfusion (0 hour) to 72 hours.

Time frame
1-72 hours

Secondary outcomes

1

Effect of using the combined use of the Efferon CT device and HVHF on systemic hemodynamic parameters

Time (number of hours) from randomization to end of vasopressor support.

Time frame
1-72 hours
2

Effect of the combined use of the Efferon CT device and HVHF on pulmonary oxygen metabolism function

Value of oxygenation index (Pa02 / Fi02 (Pa) every 24 hours ± 1 hour from the start of hemoperfusion (hour 0) to 72 hours.

Time frame
1-72 hours
3

Effect of the combined use of the Efferon CT device and HVHF on the indicators of the cardiac index

Ultrasound assessment of LVOT VTI or RVOT VTI gain

Time frame
1-72 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Efferon JSC

Lead sponsor

Source ClinicalTrials.gov
Apply now