A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS (CARPO)
Acute Pancreatitis, Systemic Inflammatory Response Syndrome
About this trial
This is an interventional treatment trial for Acute Pancreatitis
Eligibility Criteria
Inclusion Criteria:
All of the following must be met for a patient to be randomized into the study:
The diagnosis of acute pancreatitis has been established by the presence of abdominal pain consistent with acute pancreatitis together with at least 1 of the following 2 criteria:
- Serum lipase > 3 times the upper limit of normal (ULN);
- Characteristic findings of acute pancreatitis on abdominal imaging;
The diagnosis of SIRS has been established by the presence of at least two of the following four criteria:
- Temperature < 36°C or > 38°C;
- Heart rate > 90 beats/minute;
- Respiratory rate >20 breaths/minute or arterial carbon dioxide tension (PaCO2) <32 mmHg;
- White blood cell count (WBC) >12,000 mm3, or <4,000 mm3, or > 10% immature (band) forms;
At least one of the following criteria is also present:
- A peripancreatic fluid collection or a pleural effusion on a contrast-enhanced computed tomography (CECT) performed in the 24 hours before Consent or after Consent and before Randomization;
- Abdominal examination documenting either abdominal guarding or rebound tenderness;
- Hematocrit ≥44% for men or ≥40% for women;
- The patient is ≥ 18 years of age;
- Lack of pancreatic necrosis, pancreatic calcifications, pancreatic pseudocysts and no evidence for previous necrosectomy or pancreatic surgery identified by CECT performed in the 24 hours before Consent or after Consent and before Randomization;
- A female patient of childbearing potential who is sexually active with a male partner is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug. A female patient must not attempt to become pregnant for 180 days;
- A male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug. A male patient must not donate sperm for 180 days;
- The patient is willing and able to, or has a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.
Exclusion Criteria:
Patients with any of the following conditions or characteristics must be excluded from randomizing:
- Expected survival <6 months;
- Suspected presence of cholangitis in the judgment of the treating physician;
The patient has a known history of:
- Organ or hematologic transplant;
- HIV, hepatitis B, or hepatitis C infection;
- Chronic pancreatitis;
Current treatment with:
- Chemotherapy;
- Immunosuppressive medications or immunotherapy
- Pancreatic enzyme replacement therapy;
- Hemodialysis or Peritoneal Dialysis;
- The patient is known to be pregnant or is nursing;
- The patient has participated in another study of an investigational drug or therapeutic medical device in the 30 days before randomization;
- Allergy to eggs or known hypersensitivity to any components of study drug.
Sites / Locations
- University of ArkansasRecruiting
- Long Beach Medical CenterRecruiting
- Kaiser Permanente Los Angeles Medical Center
- LA County Hospital - USCRecruiting
- Cedars Sinai
- UCLA Ronald Reagan Medical CenterRecruiting
- University of California at Irvine Medical CenterRecruiting
- Harbor UCLA Medical CenterRecruiting
- Torrance Memorial Medical CenterRecruiting
- National Jewish Health
- Yale University School of Medicine
- The Stamford Hospital
- Sarasota Memorial Health Care SystemRecruiting
- Tampa General HospitalRecruiting
- St. Luke's Regional Medical CenterRecruiting
- Northwestern University HospitalRecruiting
- Robley Rex VA Medical CenterRecruiting
- Lumunis Health Anne Arundel Medical Center
- University of MarylandRecruiting
- Henry Ford Health SystemRecruiting
- Methodist HospitalRecruiting
- Regions HospitalRecruiting
- University of Missouri School of MedicineRecruiting
- Washington University School of Medicine
- Northshore University HospitalRecruiting
- Long Island Jewish Hospital
- Icahn School of Medicine at Mount SinaiRecruiting
- Ohio State UniversityRecruiting
- Regional One HealthRecruiting
- John Peter Smith HospitalRecruiting
- Houston Methodist HospitalRecruiting
- UT Health HoustonRecruiting
- University Health System at San Antonio
- University of VirginiaRecruiting
- Virginia Commonwealth University
- CAMC Institute for Academic MedicineRecruiting
- Lisie HospitalRecruiting
- Vijaya Super Speciality HospitalRecruiting
- MTES' Sanjeevan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
2.0 mg/kg (1.25 mL/kg)
1.0 mg/kg (0.625 mL/kg)
0.5 mg/kg (0.3125 mL/kg)
Placebo (1.25, 0.625, or 0.3125 mL/kg)
administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.
administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.
administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.
patients randomized to placebo will receive one of three following volumes (1.25 mL/kg, 0.625 mL/kg, and 0.3125 mL/kg. although three volumes - all patients randomized to placebo will be analyzed together as one arm. administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.