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New treatment option for Acute Pancreatitis Without Necrosis or Infection
Official title Combination of Cytokine Hemosorption and High-volume Hemofiltration in Acute Pancreatitis
ClinicalTrials.gov ID: NCT05694988
What this study is testing
- What it's testing
- 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).
- Time commitment: about 10 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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,
- APACHE II score - at least 10,
You likely can't join if
- 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,
- DS - Septic shock (Sepsis-3, 2016)
- The presence of a focus of non-sanitized surgical infection,
See the full eligibility criteria
- 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,
- APACHE II score - at least 10,
- The patient must receive adequate fluid therapy (at least 30 ml/kg) from the time of randomization until the first therapy,
- The patient's condition allows therapy for at least 4 hours.
- 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,
- DS - Septic shock (Sepsis-3, 2016)
- The presence of a focus of non-sanitized surgical infection,
- Charlson comorbidity index\> 5 points,
- Critical hypoxemia (PaO2/FiO2 \< 150 mm Hg),
- GCS level of consciousness \< 12 points,
- Obesity 3 degrees and above (weight over 150 kg),
- Blood triglyceride level \>1000 mg/dl, (11.2 mmol/l),
- Dementia,
- Inability to achieve or maintain min SBP ≥ 65 mm Hg. Art., despite vasopressor therapy and infusion therapy in tech. 24 hours
- Presence of end-stage renal disease requiring RRT,
- The presence of cirrhosis of the liver (\> 5 points according to the Child-Pugh classification),
- Unresolved biliary hypertension syndrome,
- Acute thromboembolism of the pulmonary artery, confirmed by tomography,
- Acute myocardial infarction within the last 4 weeks,
- Acute cerebrovascular accident,
- Transfusion reaction,
- Severe congestive heart failure,
- Uncontrolled bleeding (acute blood loss in the last 24 hours).
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.