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| Name | Class |
|---|---|
| University of Rijeka | OTHER |
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Patients diagnosed with acute pancreatitis regardless of etiology, severity of disease, and prior attacks will be randomized in two groups. The intervention group will receive a balanced crystalloid (Plasmalyte) at a rate of 10 ml/kg during the first 60 min and then continued at 3 ml/kg/h for the next 72 hours. The control group will receive normal saline at the same rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balanced crystalloid solution | Experimental | Balanced crystalloid solution - Plasmalyte. |
|
| Normal saline | Active Comparator | 0.9% sodium chloride solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balanced crystalloid solution | Drug | Balanced crystalloid solution (Plasmalyte) given as an initial bolus of 10 ml/kg body weight within the first 60 min after randomization, and then continued at a rate of 2 ml/kg body weight during the next 72 hours. If needed boluses may be repeated. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with New Onset Systemic inflammatory response syndrome (SIRS) | Body temperature less than 36 °C (96.8 °F) or greater than 38 °C (100.4 °F); heart rate greater than 90 beats per minute; tachypnea (high respiratory rate), with greater than 20 breaths per minute or, an arterial partial pressure of carbon dioxide less than 4.3 kilopascals (32 mmHg); white blood cell count less than 4000 cells/mm³ (4 x 109 cells/L) or greater than 12,000 cells/mm³ (12 x 109 cells/L) or the presence of greater than 10% immature neutrophils. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Number of death cases | 30 days |
| Number of participants with organ failure (transitory and persistent) | Organ failure defined according to the modified Marshall criteria |
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Inclusion Criteria:
- patients diagnosed with acute pancreatitis based on the revised Atlanta criteria who present to our hospital within 48 hours of symptoms onset, regardless of etiology, severity of disease, or prior episodes of acute pancreatitis
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Goran Poropat, MD, PhD | Contact | 0038551658191 | gporopat8@gmail.com | |
| Anja Radovan, MD | Contact | 0038551658111 | anja.radovan@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Rijeka | Recruiting | Rijeka | 51000 | Croatia |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C048013 | Plasmalyte A |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
|
| Normal saline | Drug | 0.9% sodium chloride solution given as an initial bolus of 10 ml/kg body weight within the first 60 min after randomization, and then continued at a rate of 2 ml/kg body weight during the next 72 hours. If needed boluses may be repeated. |
|
|
| 30 days |
| Number of participants with local complications | Local complications including:
| 30 days |
| Number od participants with systemic complications | Worsening of existing concomitant diseases | 30 days |
| Number of participants with infected pancreatic necrosis | Defined by positive cultures from fine-needle aspiration of necrotic tissue or by the combination of clinical deterioration with clinical signs of infection and presence of gas within the necrotic tissue on imaging in cases of culture-negative, but highly suspicious cases. | 30 days |
| Number of participants needing endoscopic / percutaneous / surgical interventions | In cases when presence of local infection or local complications (i.e. collection compressing surrounding organs and causing symptoms) requires an intervention | 30 days |
| Length of hospital stay | Number of days in hospital, from admission to discharge or death. | 30 days |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |