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| Name | Class |
|---|---|
| University of Rijeka | OTHER |
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This is a prospective, single-center, randomized, placebo-controlled, double-blind clinical trial that aims to investigate the beneficial and harmful effects of prophylactic use of imipenem in patients with predicted severe acute pancreatitis. All patients with first attack of acute pancreatitis, an onset of disease less than 72h before admission, and an APACHE II score ≥ 8 calculated within the first 24h from admission will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imipenem group | Experimental | Imipenem 3 x 500 mg i.v. daily ideally for 10 days (minimum 7 days, maximum 21 days) |
|
| Placebo group | Placebo Comparator | Identical placebo administered in identical dosage, timing and duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imipenem | Drug | A wide-spectre antibiotic from the carbapenem group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infectious complications | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 30 days | |
| Number of patients with Systemic Inflammatory Response Syndrome (SIRS) | SIRS was defined as presence of at least two following parameters for a continuous period of ≥ 48 hours: body temperature >38°C or <36°C; heart rate >90 beats per minute; hyperventilation with a respiratory rate >20 breath per minute or a PaCO2 < 32 mmHg; and white blood cell count >12000/mm3 or <4000/mm3. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Davor Stimac, MD, PhD | Department of Gastroenterology, University Hospital Rijeka | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Rijeka | Rijeka | 51000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31404018 | Derived | Poropat G, Radovan A, Peric M, Mikolasevic I, Giljaca V, Hauser G, Milic S, Stimac D. Prevention of Infectious Complications in Acute Pancreatitis: Results of a Single-Center, Randomized, Controlled Trial. Pancreas. 2019 Sep;48(8):1056-1060. doi: 10.1097/MPA.0000000000001368. |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D007239 | Infections |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015378 | Imipenem |
| D000077728 | Cilastatin, Imipenem Drug Combination |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
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| Placebo | Drug | An imipenem-matching placebo |
|
| 30 days |
| Local complications | 30 days |
| Systemic complications | 30 days |
| Number of patients with persistent and transitory organ failure (cardiovascular, respiratory, renal) | Marshall organ dysfunction scoring system (MODS) was used to define organ failure in the case of cardiovascular, renal and respiratory system function. | 30 days |
| Surgical interventions | The investigators will register the number of patients requiring surgical interventions for acute pancreatitis. | 30 days |
| Serious adverse events | 30 days |
| Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D015377 | Cilastatin |
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |