OBJECTIVES: This study aimed to investigate the efficiency of imipenem to prevent infectious complications in predicted severe acute pancreatitis (AP).
METHODS: Consecutive AP patients were randomized to imipenem 3 × 500 mg intravenously daily or an identical placebo. Exclusion criteria were prior AP, chronic pancreatitis, active malignancy, immune deficiency, active infection, concomitant antibiotic treatment, pregnancy, and patients younger than 18 years. Infectious complications including infected pancreatic necrosis, pneumonia, urinary tract infection, positive blood cultures, sepsis, and other infections were assessed as the primary outcome. Secondary outcomes included mortality, persistent organ failure, systemic inflammatory response syndrome, local complications, serious adverse events, and need for surgical intervention.
RESULTS: Forty-nine patients were randomized to each group. Infectious complications were present in 10 versus 12 of 49 patients (relative risk [RR], 0.833; 95% confidence interval [CI], 0.398-1.747). There were no significant differences in infected pancreatic necrosis (RR, 1.5; 95% CI, 0.262-8.588), pneumonia (RR, 1.5; 95% CI, 0.262-8.588), urinary tract infection (RR, 0.6; 95% CI, 0.152-2.374), positive blood cultures (RR, 0.5; 95% CI, 0.047-5.336), sepsis (RR, 0.333; 95% CI, 0.036-3.095), and other (RR, 1.333; 95% CI, 0.315-5.648). We found no significant differences in secondary outcomes.
CONCLUSIONS: Concordantly to available evidence, there is currently no ground to support prophylactic use of antibiotics in predicted severe AP.
INTRODUCTION: It's mostly accepted there's no need for routine antibiotic prophylaxis in mild cases of AP. Evidence of prevention of infectious complications in SAP is still controversial with imipenem showing potential benefit. Aims: To investigate prophylactic use of imipenem for prevention of infectious complications in predicted SAP. PATIENTS & METHODS: Consecutive AP patients with APACHE II 8 were randomly assigned in a double-blind manner to receive imipenem 3x500 mg i.v. daily or an identical placebo ideally for ten days. Infectious complications including infected pancreatic necrosis, pneumonia, urinary tract infection (UTI), positive blood cultures, sepsis, and other infections were determined as the primary outcome. Exclusion criteria were prior AP, chronic pancreatitis, active malignancy, immune deficiency, active infection, concomitant antibiotic treatment within 72 hours before enrollment, pregnant and breasfeeding women, and patients <18 years. Concomitant treatment was given equally in both groups. RESULTS: A total of 98 patients were randomized, 49 to each group. Patients were similar according to demographics and average disease severity scores. Infective complications were present in 10/49 versus 12/49 patients (P¼0, 81). There was no significant difference in specific infective complications: infective pancreatic necrosis (3/49 vs. 2/49), pneumonia (3/ 49 vs. 2/49), UTI (3/49 vs. 5/49), positive blood cultures (1/49 vs. 3/49), sepsis (1/49 vs. 2/49), and other (4/49 vs. 3/49), respectively. We found no significant differences in mortality (P¼1, 00), organ failure (P¼0, 39), and local complications (P¼0, 31). Occurrence of mycotic infections was similar in both groups. CONCLUSION: Our results add to available evidence there's currently no ground to support routine prophylactic use of antibiotics in pedicted SAP.
OBJECTIVE: The objective of this study is to evaluate the efficacy of somatostatin, ulinastatin and gabexate for the treatment of severe acute pancreatitis.
MATERIALS AND METHODS: A total of 492 patients with severe acute pancreatitis were assigned randomly into the following 4 groups: (1) somatostatin; (2) somatostatin + ulinastatin; (3) somatostatin + gabexate and (4) somatostatin + ulinastatin + gabexate. Acute physiology and chronic health evaluation II scores; clinical parameters including time of abdominal pain and distention extinct; recovering to normality of heart rate and respiration rate; amylase and blood glucose; ratios of efficacy; multiple organ dysfunction syndrome (MODS); mortality; complication; levels of endotoxin; tumor necrosis factor alpha; interleukin-6 (IL-6), IL-8 and IL-10 and side effects were analyzed.
RESULTS: Acute physiology and chronic health evaluation II scores, time of abdominal pain extinct and distention extinct, time of recovering to normality of heart rate, time of recovering to normality of respiration rate and time of recovering to normality of amylase and blood glucose were significantly decreased in the somatostatin + ulinastatin, the somatostatin + gabexate and the somatostatin + ulinastatin + gabexate subgroups compared with the somatostatin subgroup. Ratios of efficacy were significantly improved, whereas ratios of MODS, mortality and complication were significantly decreased in the somatostatin + ulinastatin and the somatostatin + ulinastatin + gabexate subgroups compared with the somatostatin subgroup. Tumor necrosis factor alpha, IL-6 and IL-8 levels on the fourth day after treatment showed significant decrease in the somatostatin + ulinastatin, the somatostatin + gabexate and the somatostatin + ulinastatin + gabexate subgroups compared with the somatostatin subgroup. The IL-10 levels on the fourth day were significantly improved in the somatostatin + ulinastatin, the somatostatin + gabexate and the somatostatin + ulinastatin + gabexate subgroups compared with the somatostatin subgroup.
CONCLUSIONS: Somatostatin is effective for the treatment of acute pancreatitis, ulinastatin demonstrates improvement in therapeutic benefits and gabexate can relieve the clinical symptoms and shorten the course of disease but cannot improve the effective ratio or decrease MODS, mortality and complication.
<b>OBJECTIVES: </b>Activated protein C (APC), an endogenous anticoagulant, has antithrombotic, fibrinolytic and anti-inflammatory properties. We recently conducted a controlled study (APCAP, activated protein C in severe acute pancreatitis) of APC treatment of patients with severe acute pancreatitis (SAP). Here we studied the effect of APC on the pivotal coagulation parameters of the surviving patients in the APCAP study.<b>METHODS: </b>The study consisted of 20 patients of whom 10 patients had received APC and 10 patients had received placebo. Coagulation parameters, physiological anticoagulants, thrombograms and circulating levels of IL-6 and CRP were determined on admission and at days 1, 3-4 and 6-7.<b>RESULTS: </b>During follow-up, the temporal levels of prothrombin time (PT) decreased and the temporal levels of thromboplastin time (TT) increased in placebo group (p< 0.001 for both), but not in APC group. The temporal levels of antithrombin (AT) increased less in APC group than in placebo group (p = 0.011). The shapes of the SAP patients' thrombograms were strongly deranged and were marginally affected by APC treatment.<b>CONCLUSIONS: </b>Coagulopathy in SAP, a complex phenomenon, is not alleviated by APC treatment. Rather, the patients receiving APC are heading toward normal homeostasis of coagulation slower than patients receiving placebo.
In acute pancreatitis (AP) tumor necrosis factor-α mediates multi-organ failure; in animal models its blockade with pentoxifylline ameliorates AP. The efficacy of pentoxifylline in predicted severe AP (pSAP) was tested in a double-blinded, randomized, control trial. Twenty-eight patients with pSAP were randomized within 72 hours of diagnosis to pentoxifylline or placebo. Baseline characteristics were similar in both groups. The pentoxifylline group had fewer intensive care unit admissions and shorter intensive care unit and hospital stays of longer than 4 days (all P < .05). Patients receiving pentoxifylline had no adverse effects. Pentoxifylline within 72 hours of pSAP is safe; a larger study of pentoxifylline in AP is needed to confirm efficacy. ClinicalTrials.gov number: NCT01292005.
Conference»23rd United European Gastroenterology Week. Published in: United European Gastroenterology Journal
Year»2015
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Introduction: Infected necrosis is a serious complication of acute pancreatitis leading to a mortality rate of about 40%1. Although prophylactic antibiotics are not recommended, meta-analytic data show that imipenem significantly reduces the rate of infected necrosis1. Aims & Methods: The aim of our study is to evaluate the prophylactic use of imipenem in patients with predicted severe acute pancreatitis. We conducted a prospective randomized trial in a tertiary care setting in Rijeka. Patients with AP and an APACHE II8 were randomized to receive either imipenem 500 mg i.v. three times daily for the first ten days or an identical placebo. Exclusion criteria included age518 years, any infection present at admission, chronic pancreatitis, active malignancy, immunodeficiency, post-surgical patients, pregnant and breastfeeding women and patients unwilling to participate in the study. All patients received early enteral nutrition administered via a nasojejunal tube. Concomitant treatment was similar in both groups. All patients had an abdominal CT scan performed between days 3 to 7, and in cases of clinically suspected infected pancreatic necrosis. Results: Forty-seven consecutive patients were randomized. Twenty-three received imipenem and 24 received placebo. Three patients died in the imipenem group, while two patients died in the placebo group (p=0.667). There were no differences in the occurrence of infected necrosis, with 2 vs. 3 cases, respectively. Other local complications were present in 7 and 13 patients (p=0.142), while persistent organ failure was present in 4 and 5 patients (p=1.00) in the imipenem and placebo group, respectively. Other infection were detected in 2 patients receiving imipenem and 5 patients on placebo(p=0.416). Conclusion: Preliminary data showed no significant beneficial effects of prophylactic imipenem use in patients with predicted severe acute pancreatitis.
OBJECTIVE: To explore the clinical efficacy and safety of ulinastatin plus octreotide for patients with severe acute pancreatitis (SAP).
METHODS: During January 2011 to January 2014 at our hospital, 120 SAP patients were randomly divided into control and observation groups (n = 60 each). The control group received an injection of octreotide injection while the observation group had a combination of ulinastatin and octreotide. After treatment, clinical efficiency, serum indicators and their improvements and complications were compared for two groups.
RESULTS: The overall efficiency of observation group was significantly higher than that of control group (83.3% vs 65.0%, P < 0.05). And abdominal pain relief time, decompression time, surgical intervention rate, length of stay and mortality rate of observation group (1.9 ± 0.9 d, 6.3 ± 2.2 d, 1.7%, 11.8 ± 0.5 d, 5%) were significantly lower than those of control group (3.6 ± 0.7 d, 10.4 ± 3.1 d, 8.3%, 23.7 ± 2.1 d, 15.0%) (P < 0.05). After treatment, the levels of blood amylase, white blood cell (WBC), C-reactive protein (CRP) and interleukin 6 (IL-6) of observation group (107.2 ± 9.1 U/L, 6.2 ± 1.0 × 10(9)/L, 7.3 ± 3.4 mg/L, 28.3 ± 4.3 pg/ml) were significantly lower than those of control group (430.8 ± 20.2) U/L, (11.2 ± 1.2) × 10(9)/L, (16.3 ± 5.2) mg/L, (45.3 ± 5.9) ng/L, (P < 0.05). And the incidences of such complications as acute respiratory distress syndrome (ARDS), acute renal failure and shock of observation group (10.0%, 5.0%, 13.3%) were significantly lower than those of control group (36.7%, 21.7%, 33.3%) (P < 0.05).
CONCLUSION: Ulinastatin plus octreotide can significantly improve the serum and clinical parameters and reduce the incidence of complications in SAP patients. And it is worthy of wider popularization.
