Potassium chloride; Sodium chloride; Calcium chloride dihydrate; Sodium lactate for Acute pancreatitis

Inclusion criteria

• {"criterion_text":"- 18 years of age"}
• {"criterion_text":"- Diagnosis of acute pancreatitis according to the revision of the Atlanta classification (Banks et al, Gut 2013), which requires at least two of the following three criteria: A) typical abdominal pain, B) increase in serum amylase or lipase levels higher than three times the upper limit of normality, and C) signs of acute pancreatitis in imaging"}
• {"criterion_text":"- Signature of informed consent"}

Exclusion criteria

• {"criterion_text":"- New York Heart Association class II heart failure (slight limitation of physical activity; fatigue, palpitations, or dyspnea with ordinal physical activity) or worse, or ejection fraction <50% in the last echocardiography"}
• {"criterion_text":"- Chronic pancreatitis defined by a Wirsung duct ≥4mm and/or pancreatic calcifications"}
• {"criterion_text":"- More than 1 previous episode of acute pancreatitis (only 2 episodes of acute pancreatitis are allowed, one of them the present episode)"}
• {"criterion_text":"- Decompensated cirrhosis (Child’s class B or C)"}
• {"criterion_text":"- Hyper or hyponatremia (<135 or >145 mEq/L)"}
• {"criterion_text":"- Hyperkalemia (>5 mEq/L)"}
• {"criterion_text":"- Hypercalcemia (albumin or protein-corrected calcium >10.5 mg/dL or 2.62 mmol/L)"}
• {"criterion_text":"- Criteria for moderately severe or severe acute pancreatitis (revision of the Atlanta classification, Banks et al, Gut 2013) at recruitment: any of the following: A) presence of creatinine ≥1.9 mg/dL or ≥170 mmol/l, B) PaO2/FiO2≤300, C) systolic blood pressure <90 mmHg despite initial fluid resuscitation, D) presence of local complications (acute peripancreatic fluid collections, acute necrotic collection, pseudocyst, walled-off necrosis, gastric outlet dysfunction, splenic or portal vein thrombosis, or colonic necrosis), E) exacerbation of previous comorbidity such as coronary artery disease or chronic lung disease, precipitated by the acute pancreatitis"}
• {"criterion_text":"- Signs of volume overload or heart failure at recruitment (peripheral edema, pulmonary rales, or increased jugular ingurgitation at 45º)"}
• {"criterion_text":"- Time from pain onset to arrival to emergency room >24 h"}
• {"criterion_text":"- Time from confirmation of pancreatitis to randomization >8 h"}

Primary endpoints

• {"endpoint_text":"- The primary outcome will be moderately severe to severe AP, according to the revision of the Atlanta classification. The primary safety outcome will be a composite variable involving any of the following: fluid overload, acute kidney injury, hyperkalemia, hypercalcemia, or acidosis.","definition_or_measurement_approach":"Severity classified using the revision of the Atlanta classification (Banks et al, Gut 2013). Safety measured as a composite of specified events: fluid overload, acute kidney injury, hyperkalemia, hypercalcemia, or acidosis."}

Hungary

Earliest CTIS Part Ii Submission Date

29-04-2024

Latest Decision Or Authorization Date

17-05-2024

Processing Time Days

18

Number Of Sites

1

Number Of Participants

720

Primary sponsor

Full Name

Semmelweis University

Organisation Type

Educational Institution

Country Of Registered Address

Hungary