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Comparison of aggressive versus standard intravenous hydration for clinical improvement in mild acute pancreatitis patient: A randomized controlled trial

Phase 3
Completed
Conditions
Patient presented with acute pancreatitis mild severity
Mild acute pancreatitis
Registration Number
TCTR20210223008
Lead Sponsor
Department of medicine, Phramongkutklao hospital
Brief Summary

Aggressive intravenous hydration did not statistically significant improve the clinical outcome compared with standard intravenous hydration (45.45% vs 31.82%, respectively; p-value 0.353). However, sub-group analysis between obese and non-obese patient, aggressive intravenous hydration was a significant improve the clinical outcome within first 24 hours

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
44
Inclusion Criteria

Patients aged >18 years who admitted to emergency department were diagnosed acute pancreatitis using Revised Atlanta classification defined by two of three following criteria: (1) epigastric abdominal pain, (2) elevated serum amylase and/or lipase greater than 3 times the upper limit of normal, (3) characteristic findings from abdominal imaging.

Exclusion Criteria

Exclusion criteria included advanced aged greater than 80 years old, New York Heart Association Class II or greater heart failure, active myocardial ischemia, cardiovascular intervention within previous 60 days, history of cirrhosis, renal insufficiency with creatinine clearance < 40 mL/min, chronic obstructive pulmonary disease with requirement home oxygen, patients with bowel ischemia or bowel perforation, hypercalcemia, clinical signs of volume overload, post-intervention pancreatitis and severe pancreatitis (PO2/FiO2 < 300, Systolic blood pressure < 90 mmHg, Serum creatinine > 2 mg/dl). Patients with history of metastasis malignancy, autoimmune disease, chronic infectious disease including human immunodeficiency virus or tuberculosis were excluded because of potential confounding related to inflammatory markers.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Clinical improvement 36 hours decrease in hematocrit, BUN, and serum creatinine from baseline, decrease in epigastric pain level and tolerance of oral intake.
Secondary Outcome Measures
NameTimeMethod
development of SIRS 36 hours at least two of the following heart rate 90, WBC 12000, RR 20 Temp 38 C,development of severe pancreatitis 36 hours by Revised Atlanta classification,complication from volume overload 36 hours Clinical and physical examination and imaging,Relief of epigastric pain 36 hours VAS scores
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