Sever Acute Pancreatitis
Conditions
Interventions
Balanced crystalloids group:Patients in a treatment block randomized to physiologically-balanced isotonic fluid will receive Sterofundin ISOTM whenever isotonic intravenous fluid administration is ord
Saline group:Patients in a treatment block randomized to saline fluid will receive 0.9% Saline whenever isotonic intravenous fluid administration is ordered by the treating provider before death, disc
Sponsors
Jinling Hospital affiliated to Nanjing University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Symptoms and signs of acute pancreatitis based on abdominal pain suggestive of AP, serum amylase at least three times the upper limit of normal, and/or characteristic findings of AP on computed tomography; 2. Within 72 hours from the onset of the disease; 3. Aged between 18 to 70 years old; 4. APACHEII >= 8; 5. CRP > 150mg/L.
Exclusion criteria
Exclusion criteria: 1. Patients who are pregnant or lactating at the time of enrollment; 2. Patients who receive percutaneous drainage for pancreatic necrosis or surgery before admission or require emergency surgery due to abdominal compartment syndrome, etc. 3. Patients who undergo RRT before admission; 4. Patients who need RRT at admission for life-threatening changes in fluid, electrolyte, and acid-base balance; 5. Patients who present with respiratory failure, severe systemic circulatory failure, coma, or other dangerous symptoms that were difficult to reverse and who were predicted to die within 24 hours (under full-fluid resuscitation and norepinephrine usage at a dose of 25 mg/min or more, with a systolic blood pressure <90mm Hg and serum pH values <7.0); 6. Patients with a known history of severe cardiovascular, respiratory, renal, hepatic, hematologic, or immunologic disease defined as (1) greater than New York Heart Association class II heart failure; (2) active myocardial ischemia or (3) cardiovascular intervention within previous 60 days; (4) history of cirrhosis or (5) chronic kidney disease with creatinine clearance< 40 mL/min, or (6) chronic obstructive pulmonary disease with requirement for home oxygen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma chloride concentration at day3 after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| MAKE 30 (Major Adverse Kidney Events by hospital discharge or day 30);30-day In-hospital mortality;New Renal Replacement Therapy by day 30;Persistent renal dysfunction;Requirement of ICU admission during the index admission;Intensive care unit free days to day 30;Ventilator-free days to day 30;Vasopressor-free days to day 30;Renal replacement therapy-free survival to day 30;New-onset of organ dysfunction;Daily SOFA score from day1 to day7;Daily SIRS score from day1 to day7;Daily assessment of abdominal pain (VAS score) from day1 to day7 ;Intravenous morphine equivalent dose from day1 to day7;Proportion of intolerance to solid diet from day1 to day7;Occurrence of infected pancreatic necrosis (IPN) during the index admission;Occurrence of sepsis during the index admission.;Occurrence of intra-abdominal bleeding during the index admission.;Occurrence of gastrointestinal fistula during the index admission.;Occurrence of all-cause mortality during the index admission.;Requirement of open surgery during the index admission.; | — |
Countries
China
Contacts
Public ContactLi Weiqin
Jinling Hospital affiliated to Nanjing University
Outcome results
None listed