Fluid Resuscitation in Acute Pancreatitis

Study Overview
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Brief Summary
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The aim of this study is to establish the influence of early administration of a bolus of intravascular fluid in patients with a diagnosis of acute pancreatitis on the course and outcome of disease.

Detailed Description
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This is a prospective, randomized, controlled clinical trial of standard versus enhanced hydration in patients diagnosed with acute pancreatitis within the first hour of diagnosis. Patients admitted in the Emergency Department with the clinical suspicion of acute pancreatitis will be processed through the history, physical examination and laboratory findings. The diagnosis of acute pancreatitis is established by the presence of 2 of the 3 following criteria: typical abdominal pain, serum amylase and / or lipase greater than three times the upper limit of normal, and characteristic findings from abdominal imaging. Patients will be informed about the study protocol and the possible risks and adverse events, after which they will be asked to accept participation in the study. Acceptance of participation will be confirmed by signed informed consent. After acceptance patients will be randomized by computer-generated sequences of random numbers in the two groups Group one (1) will receive a bolus of fluid 20 ml / kg of Ringer's solution for infusion within one hour of the diagnosis and the group two (2) will receive a bolus of fluid 40 ml / kg of Ringer's solution for infusion within one hour of the diagnosis. All patients who have the diagnosis of acute pancreatitis, but did not agree to participate in research or have some other exclusion criteria will be treated according to the standards of good clinical practice and the recommendations of the current clinical guidelines for the treatment of acute pancreatitis. Exclusion criteria beside refusal to sign informed consent are: age less than 18 years, pregnancy, patients with physical signs of heart failure, previously known congestive heart failure (NYHA III - IV) and severe kidney disease more than one month before the diagnosis of acute pancreatitis (defined as severe reduction in eGFR less than 30 ml/min/1.73 m2). Patients who develop acute renal failure as a result of acute pancreatitis will be involved in research . Given the importance of early hydration in patients with acute pancreatitis and the lack of clearly defined dose of administered fluid in the current literature, aim of this study was to determine the influence of the size of the dose bolus of intravascular fluid after the diagnosis of acute pancreatitis in the further course and outcome of disease. The study will be conducted in the Emergency Department, Clinical Hospital Centre, Rijeka.

Official Title
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Randomized Trial of Standard vs. Enhanced Hydration in Patients With a Diagnosis of Acute Pancreatitis Within the First Hour of the Diagnosis

Conditions
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Pancreatitis

Intervention / Treatment
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* Drug: Ringer lactate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with diagnosis of acute pancreatitis. Exclusion Criteria: Refusal to sign informed consent Age less than 18 years Pregnancy Patients with physical signs of heart failure, Previously known congestive heart failure ( NYHA III - IV ) Severe kidney disease more than one month before the diagnosis of acute pancreatitis (defined as severe reduction in eGFR less than 30 ml/min/1.73 m2) . Patients who develop acute renal failure as a result of acute pancreatitis will be involved in research .

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ringer lactate 20 mL/kg<br>This group of subjects will receive a bolus of 20 ml / kg of Ringer's solution for infusion within first hour of the diagnosis | Drug: Ringer lactate<br> <br> |
| Experimental: Ringer lactate 40 ml/kg<br>This group of subjects will receive a bolus of 40 ml / kg of Ringer's solution for infusion within first hour of the diagnosis | Drug: Ringer lactate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of mortality | Number of participants with fatal outcome during hospitalisation | Until hospital discharge or maximum of 1 month | 
| Development of severe pancreatitis | Number of participants with severe pancreatitis during hospitalisation (according to revised Atlanta criteria) | Until hospital discharge or maximum of 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of peripancreatic collection | Number of participants with development of peripancreatic collection during hospitalisation | Until hospital discharge or maximum of 1 month | 
| Development of pancreatic collection infection | Number of participants with development of pancreatic collection infection during hospitalisation | Until hospital discharge or maximum of 1 month | 
| Development of systemic inflammatory response syndrome (SIRS) | Number of participants with development of systemic inflammatory response syndrome (SIRS) | Until hospital discharge or maximum of 1 month | 
| Development of metabolic acidosis | Number of participants with development of metabolic acidosis | Until hospital discharge or maximum of 1 month | 
| Development of acute respiratory distress syndrome (ARDS ) defined according to the current Berlin definition | Number of participants with development of acute respiratory distress syndrome (ARDS ) defined according to the current Berlin definition | Until hospital discharge or maximum of 1 month | 
| Adverse events | All events during the treatment of patients who may or may not be associated with acute pancreatitis and / or replacement of fluids | Until hospital discharge or maximum of 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute pancreatitis, Fluid resuscitation, Crystalloids