Detailed Description Acute pancreatitis (AP) is a common gastrointestinal disorder
requiring hospitalization, with an incidence of approximately 40 cases per 100,000
individuals. The severity of AP ranges from mild to severe, with 15-20% of cases
progressing to severe acute pancreatitis (SAP), which is characterized by organ failure
and local complications. The mortality rate for severe acute pancreatitis remains high,
reaching 20-30%, highlighting the critical need for early and adequate fluid
resuscitation in emergency settings.
Despite universal recommendations for early-volume resuscitation, there is no clear
consensus regarding the optimal fluid type, infusion rate, total volume, or monitoring
strategy. Fluid resuscitation's primary objective is to prevent or minimize systemic
inflammatory response syndrome (SIRS), which significantly contributes to AP progression.
This randomized controlled trial (RCT) will compare the effectiveness of a
colloid-crystalloid combination (Dextran 40 in sodium chloride [NaCl] 0.9 grams per liter
[g/L] solution and Ringer's lactate solution in a 1:3 ratio) versus Ringer's lactate
solution alone in preventing disease progression and reducing complications in patients
with mild or moderate AP.
Study Design This randomized clinical trial (RCT) will be conducted at Satu Mare County
Emergency Hospital and enroll approximately 100 patients diagnosed with mild or moderate
AP.
Fluid Administration Rate: 1,5 mL/kg/h, based on patient hemodynamic status.
Data Collection and Assessment
Clinical and Demographic Data:
Age, sex.
Lifestyle factors (alcohol consumption, smoking).
Symptom onset time and severity classification (based on the Revised Atlanta
-Classification, 2012).
=Diagnostic Criteria (Requires ≥2 of 3):
Acute upper abdominal pain.
Serum amylase/lipase levels ≥3 times the upper standard limit (ULN).
Imaging findings (CT, ultrasound, or MRI) consistent with AP.
Organ Failure Assessment:
-Modified Marshall Scoring System (2012).
Severity Scoring:
Laboratory Biomarkers & Monitoring
Blood samples will be collected at admission and every 24 hours to assess:
Pancreatic Enzymes: Amylase, lipase.
Inflammatory Markers & Organ Function Parameters:
C-reactive protein (CRP).
Erythrocyte sedimentation rate (ESR).
Hematocrit.
Urea, creatinine.
Systemic inflammatory response syndrome (SIRS) markers.
Fibrinogen, ferritin.
Procalcitonin at enrollment and 72 hours.
Additional Monitoring:
An ultrasound will measure the Inferior vena cava (IVC) diameter and collapsibility index
to estimate central venous pressure (CVP) and hemodynamic status.
Urine output every 24 hours (target ≥0.5 mL/kg/h as an adequate resuscitation marker).
Primary and Secondary Outcome Measures
Primary Outcomes:
Reduction in C-reactive protein (CRP) and SIRS
Secondary Outcomes:
Reduced duration of hospitalization and lower ICU admission rates.
Reduction of erythrocyte sedimentation rate (ESR) and other inflammatory markers.
Complication rates (e.g., pancreatic necrosis, organ failure).
Hospitalization costs.
In-hospital mortality and follow-up mortality at 3 months.
Follow-up and Study Endpoints Patients will be monitored throughout hospitalization and
followed up at 12 weeks post-discharge.
Expected Impact This study aims to identify the optimal fluid resuscitation strategy for
mild and moderate AP. If the colloid-crystalloid combination proves superior, it could
lead to changes in clinical guidelines for AP management, potentially reducing organ
failure, ICU admissions, and mortality rates.