Balanced Crystalloid Solutions for Acute Pancreatitis

Study Overview
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Brief Summary
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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.

Official Title
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Treatment With Balanced Crystalloid Solutions in the Early Phase of Acute Pancreatitis

Conditions
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Acute Pancreatitis

Intervention / Treatment
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* Drug: Balanced crystalloid solution
* Drug: Normal saline


Participation Criteria
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Eligibility 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: chronic pancreatitis liver cirrhosis (Child-Pugh B and C) chronic hearth failure (NYHA>II) acute coronary syndrome cardiovascular intervention within 60 days before randomization chronic obstructive pulmonary disease dependent of home oxygenator or acute exacerbation of chronic obstructive pulmonary disease chronic kidney disease (eGFR <30 ml/min/1.73 m2) concomitant biliary infection (cholecystitis, cholangitis) severe autoimmune disease chronic active infection (TBC, AIDS) metastatic malignant disease primary pancreatic neoplasm patients transferred from other hospitals pregnancy and ongoing breastfeeding not willing to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balanced crystalloid solution<br>Balanced crystalloid solution - Plasmalyte. | Drug: Balanced crystalloid solution<br>* 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.<br>* Other names: Plasmalyte; balanced crystalloids;|
| Active Comparator: Normal saline<br>0.9% sodium chloride solution. | Drug: Normal saline<br>* 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.<br>* Other names: Saline; 0.9% sodium chloride solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 30 days | 
| Number of participants with local complications | Local complications including: acute peripancreatic fluid collection acute necrotic collection pseudocyst walled-off necrosis | 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 |