Primary studies included in this systematic review

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Primary study

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Prevention of Infectious Complications in Acute Pancreatitis: Results of a Single-Center, Randomized, Controlled Trial.

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Journal Pancreas
Year 2019
Links Pubmed DOI

This article is included in 3 Systematic reviews Systematic reviews (3 references)

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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.

Primary study

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Procalcitonin is a good tool to guide duration of antibiotic therapy in patients with severe acute pancreatitis. A randomized prospective single-center controlled trial.

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Authors Qu R , Ji Y , Ling Y , Ye CY , Yang SM , Liu YY , Yang RY , Luo YF , Guo Z
Journal Saudi medical journal
Year 2012
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This article is included in 1 Systematic review Systematic reviews (1 reference)

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OBJECTIVE: To investigate the clinical usefulness of procalcitonin (PCT) for guiding duration of antibiotic therapy in patients with severe acute pancreatitis (SAP). METHODS: A total of 71 patients with confirmed severe acute pancreatitis from March 2009 to September 2011 in the Department of Critical Care Medicine of Huizhou Municipal Central Hospital, Guangdong, China were enrolled in this study. Procalcitonin was measured daily by a semi-quantitative immunoassay in the study group. Patients were randomly assigned into 2 groups including a PCT-guided group (study group) and a prophylactic antibiotic therapy (control group). Antibiotic therapy in the study group was not applied until clinical signs and symptoms of infection appeared (PCT value was >0.5ng/ml). We discontinued the antibiotic therapy if clinical signs and symptoms of infection improved and PCT was <0.5ng/ml over 3 days. In the control group, antibiotic therapy was administrated for 2 weeks, or antibiotic therapy was continued because of confirmed infection until clinical signs and symptoms of infection disappeared over 3 days. RESULTS: In the study group (35 patients), the duration of antibiotic therapy and hospitalization was significantly shorter than the control group (36 patients) (10.89+/-2.85 versus 16.06+/-2.48 days, p<0.001, and 16.66+/-4.02 days versus 23.81+/-7.56 days, p<0.001) without negative clinical effects and the cost of hospitalization was significantly lower. CONCLUSION: Procalcitonin is a helpful and safe tool for guiding duration of antibiotic treatment in patients with severe acute pancreatitis.

Primary study

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Prophylactic antibiotic treatment for severe acute necrotizing pancreatitis

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Conference European Journal of Anaesthesiology
Year 2012
Links European Journal of Anaesthesiolog

This article is included in 2 Systematic reviews Systematic reviews (2 references)

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BACKGROUND AND GOAL OF STUDY: In patients with severe, necrotizing pancreatitis, it is common to administer prophylactic broad-spectrum antibiotics, as imipenem, to reduce the incidence of pancreatic and peripancreatic infections. The aim of this double-blind, placebo-controlled, randomized study was to evaluate the effectiveness of prophylactic intravenous imipenem in preventing pancreatic and / or peripancreatic infection in patients with non infected necrotizing pancreatitis when compared with placebo. MATERIALS AND METHODS: A prospective, double-blind, placebo-controlled randomized study set in ICU of HUC „Mother Theresa“. There were involved 80 patients with clinically severe, confirmed necrotizing pancreatitis in the study: 40 patients received imipenem (750 mg i.v. every 12 hours) and 40 other patients received placebo. Treatment started within 5 days of the onset of symptoms. Treatment continued for 7 days. Patients were followed for 42 days following randomization, focusing in development of complications (infection, the need of surgery and mortality). RESULTS AND DISCUSSION: Pancreatic or peripancreatic infections developed in 15% (6 of 40) of patients in the imipenem group compared with 10% (4 of 40) in the placebo group (P = 0.401). Overall mortality rate was 20% (8 of 40) in the imipenem group and 15% (6 of 40) in the placebo group (P = 0.799). Surgical intervention was required in 25% (10 of 40) and 20% (8 of 40) of the imipenem and placebo groups, respectively (P = 0.476). CONCLUSION(S): This study demonstrated no statistically significant difference between the treatment groups for pancreatic or peripancreatic infection, mortality, or requirement for surgical intervention. So, it did not support early prophylactic antimicrobial use in patients with severe acute necrotizing pancreatitis.

Primary study

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A double-blind, placebo-controlled trial of ciprofloxacin prophylaxis in patients with acute necrotizing pancreatitis

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Journal Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract
Year 2009
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This article is included in 11 Systematic reviews Systematic reviews (11 references) 4 Broad syntheses Broad syntheses (4 references)

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Background: The use of prophylactic antibiotics in acute severe necrotizing pancreatitis is controversial. Methods: Prospective, randomized, placebo-controlled, double-blind study was carried out at Bellvitge Hospital, in Barcelona, Spain. Among 229 diagnosed with severe acute pancreatitis, 80 had evidence of necrotizing pancreatitis (34/80 patients were excluded of the protocol). Forty-six patients without previous antibiotic treatment with pancreatic necrosis in a contrast-enhanced CT scan were randomly assigned to receive either intravenous ciprofloxacin or placebo. Five patients were secondarily excluded, and the remaining 41 patients were finally included in the study (22 patients received intravenous ciprofloxacin and 19 patients placebo). Results: Comparing the 22 with intravenous ciprofloxacin and 19 with placebo, infected pancreatic necrosis was detected in 36% and 42% respectively (p∈=∈0.7). The mortality rate was 18% and 11%, respectively (p∈=∈0.6). No significant differences between both treatment groups were observed with respect to variables such as: non-pancreatic infections, surgical treatment, timing and the re-operation rate, organ failure, length of hospital and ICU stays. Conclusion: The prophylactic use of ciprofloxacin in patients with severe necrotizing pancreatitis did not significantly reduce the risk of developing pancreatic infection or decrease the mortality rate. The small number of patients included in this study should be considered. © 2008 The Society for Surgery of the Alimentary Tract.

Primary study

Unclassified

Is the prophylactic antibiotic therapy with imipenem effective for patients with pancreatic necrosis?

Journal Acta gastroenterologica Latinoamericana
Year 2009
Links Pubmed

This article is included in 3 Systematic reviews Systematic reviews (3 references) 2 Broad syntheses Broad syntheses (2 references)

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Objetive: to evaluate the capacity of Imipenem as a prophylactic treatment for decreasing the number of infected necrosis and surgeries, as well as for diminishing septic complications and the mortality rate among patients with severe acute necrotizing pancreatitis. Mterial and Methods: from May 2005 to December 2007 a prospective randomized study was conducted in order to evaluate the efficacy of a prophylactic antibiotic therapy in patients with pancreatic necrosis. During this time period 58 patients entered the study protocol. Patients were divided in two groups; the first one underwent antibiotic therapy with Imipenem while the second group received no prophylactic treatment at all. All patients received early enteral nutrition. Results: both studied groups had comparable age, gender ratio, and C.R.P. and necrosis percentages. When comparing general morbidity in both groups no difference was found between the group receiving a prophylactic antibiotic and the group that did not receive it (58% vs. 56%). Moreover, when the septic complications were evaluated, it was confirmed that these were more frequent among the group of patients receiving Imipenem (29%), in comparison to the group that did not received antibiotics (15%). 12.5% of the patients that received Imipenem developed pancreatic necrosis infection, while said infection only appeared in 6% of the patients in the group that did not receive antibiotic prophylaxis; nevertheless, none of the comparisons reached statistical significance. The number of patients who required surgery was similar in both groups. When comparing the hospital stay, it was observed that this was longer among the patients receiving prophylactic therapy. No patient died during the study. Conclusion: The present study finds no benefits in the use of antibiotic therapy with Imipenem regarding the risk of developing pancreatic necrosis infection and septic complications, and neither when trying to reduce the number of surgeries among patients with severe acute pancreatitis with necrosis.

Primary study

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Effect of antibiotic prophylaxis on acute necrotizing pancreatitis: Results of a randomized controlled trial

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Authors Xue P , Deng LH , Zhang ZD , Yang XN , Wan MH , Song B , Xia Q
Journal Journal of gastroenterology and hepatology
Year 2009
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This article is included in 13 Systematic reviews Systematic reviews (13 references) 4 Broad syntheses Broad syntheses (4 references)

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Background and Aims: This study addresses whether antibiotic prophylaxis is beneficial for acute necrotizing pancreatitis. Methods: This randomized, controlled trial enrolled 276 patients with severe acute pancreatitis. There were 56 patients with 30% or more necrosis proved by contrast-enhanced computerized tomography who were eligible for randomization: 29 in the study group and 27 in the control group, who received i.v. imipenem-cilastatin (3 × 500 mg/day) within 72 h of the onset of symptoms for 7-14 days, and no antibiotic prophylaxis, respectively. The primary end-point was the incidence of infectious complication. The secondary end-points were mortality, the incidence of necrosectomy for infected necrosis, the incidence of organ complication and hospital courses. Results: Characteristics of baseline data were similar in the two groups. No significant differences were found in the incidence of infected pancreatic necrosis (37% vs 27.6%), mortality (10.3% vs 14.8%) and the incidence of operative necrosectomy (29.6% vs 34.6%) between the study group and the control group (P > 0.05). The incidence of extrapancreatic infections, organ complications and hospital courses between the groups were also not significantly different. However, a significantly increased incidence of fungal infection was observed in the study group versus the control group (36.1% vs 14.2%, P < 0.05). Conclusion: There was no benefit in the outcomes when antibiotic prophylaxis was routinely used in patients with acute necrotizing pancreatitis. © 2009 Journal of Gastroenterology and Hepatology Foundation and Blackwell Publishing Asia Pty Ltd.

Primary study

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Non-preventive use of antibiotics in patients with severe acute pancreatitis treated with integrated traditional Chinese and Western medicine therapy: A randomized controlled trial

Authors Yang XN , Deng LH , Xue P , Zhao L , Jin T , Wan MH , Xia Q
Journal Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine
Year 2009
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This article is included in 2 Systematic reviews Systematic reviews (2 references) 2 Broad syntheses Broad syntheses (2 references)

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Objective: To investigate the prognostic effects of integrated traditional Chinese and Western medicine therapy without antibiotics in treatment of patients with severe acute pancreatitis (SAP). Methods: SAP patients were randomly divided into treatment group (26 cases included) and control group (28 cases included). In addition to the same protocol of integrated traditional Chinese and Western medicine treatment for both groups, intravenous drip infusion of 0.5 g imipenem-cilastatin was administered to the patients in the control group every eight hours for ten days. The 48-hour Ranson score, 24-hour acute physiology and chronic heath evaluation II score, and incidence rates of complications were observed. The concentrations of serum C-reactive protein (CRP) on days 1, 3, 7 and 10 were measured, and strains of infection were detected with smear and culture examination for bacteria and fungi. Results: There were no statistical differences in demographic information, baseline-data and incidence rates of complications between the two groups (P>0.05), but fungal infection rate in the control group was higher than that in the treatment group (P<0.05). There were no statistical differences in infection rates of G- and G+ germs between the two groups; blood and some organs including lung, pancreas, intestine, and urethra were infected with bacteria and fungi. There were also no significant differences in the serum CRP concentrations on days 1, 3, 7 and 10 between the two groups (P>0.05), but the serum CRP concentrations on days 1, 3, 7 and 10 in infected patients were higher than those in non-infected patients (P<0.05, P<0.01). Conclusion: The study cannot confirm that the incidence rates of secondary infection and mortality in SAP patients treated with integrated traditional Chinese and Western medicine are reduced by prophylaxis with imipenem-cilastatin.

Primary study

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Early treatment of severe pancreatitis with imipenem: a prospective randomized clinical trial.

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Journal Scandinavian journal of gastroenterology
Year 2007
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This article is included in 16 Systematic reviews Systematic reviews (16 references) 5 Broad syntheses Broad syntheses (5 references)

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OBJECTIVE: The main causes of death in severe pancreatitis are multiorgan failure and septic complications. Prophylactic treatment with effective antibiotics is therefore a tempting therapeutic option. However, there could be side effects such as selection of resistant microbes and fungi. The aim of the present study was to compare the rate of infectious complications, interventions, days in the intensive care unit (ICU), morbidity and mortality in patients with severe pancreatitis randomized to prophylactic therapy with imipenem compared with those receiving no treatment at all. MATERIAL AND METHODS: Seventy-three patients with severe pancreatitis were included in a prospective, randomized, clinical study in seven Norwegian hospitals. The number of patients was limited to 73 because of slow patient accrual. Severe pancreatitis was defined as a C-reactive protein (CRP) level of >120 mg/l after 24 h or CRP >200 48 h after the start of symptoms. The patients were randomized to either early antibiotic treatment (imipenem 0.5 g x 3 for 5-7 days) (imipenem group) (n=36) or no antibiotics (control group) (n=37). RESULTS: The groups were similar in age, cause of pancreatitis, duration of symptoms and APACHE II score. Patients in the imipenem group experienced lower rates of complications (12 versus 22 patients) (p=0.035) and infections (5 versus 16 patients) (p=0.009) than those in the control group. There was no difference in length of hospital stay (18 versus 22 days), need of intensive care (8 versus 7 patients), need of acute interventions (10 versus 13), nor for surgery (3 versus 3) or 30-day mortality rates (3 versus 4). CONCLUSIONS: The study, although underpowered, supports the use of early prophylactic treatment with imipenem in order to reduce the rate of septic complications in patients with severe pancreatitis.

Primary study

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Early antibiotic treatment for severe acute necrotizing pancreatitis: a randomized, double-blind, placebo-controlled study.

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Journal Annals of surgery
Year 2007
Links Pubmed DOI PubMed Central

This article is included in 18 Systematic reviews Systematic reviews (18 references) 5 Broad syntheses Broad syntheses (5 references)

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BACKGROUND & AIMS: In patients with severe, necrotizing pancreatitis, it is common to administer early, broad-spectrum antibiotics, often a carbapenem, in the hope of reducing the incidence of pancreatic and peripancreatic infections, although the benefits of doing so have not been proved. METHODS: A multicenter, prospective, double-blind, placebo-controlled randomized study set in 32 centers within North America and Europe. Participants: One hundred patients with clinically severe, confirmed necrotizing pancreatitis: 50 received meropenem and 50 received placebo. Interventions: Meropenem (1 g intravenously every 8 hours) or placebo within 5 days of the onset of symptoms for 7 to 21 days. Main Outcome Measures: Primary endpoint: development of pancreatic or peripancreatic infection within 42 days following randomization. Other endpoints: time between onset of pancreatitis and the development of pancreatic or peripancreatic infection; all-cause mortality; requirement for surgical intervention; development of nonpancreatic infections within 42 days following randomization. RESULTS: Pancreatic or peripancreatic infections developed in 18% (9 of 50) of patients in the meropenem group compared with 12% (6 of 50) in the placebo group (P = 0.401). Overall mortality rate was 20% (10 of 50) in the meropenem group and 18% (9 of 50) in the placebo group (P = 0.799). Surgical intervention was required in 26% (13 of 50) and 20% (10 of 50) of the meropenem and placebo groups, respectively (P = 0.476). CONCLUSIONS: This study demonstrated no statistically significant difference between the treatment groups for pancreatic or peripancreatic infection, mortality, or requirement for surgical intervention, and did not support early prophylactic antimicrobial use in patients with severe acute necrotizing pancreatitis.

Primary study

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Antibiotic prophylaxis in large pancreatic necrosis: multicenter randomized trial with ciprofloxacin and metronidazole or meropenem.

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Journal Gastroenterology
Year 2004

This article is included in 6 Systematic reviews Systematic reviews (6 references) 2 Broad syntheses Broad syntheses (2 references)

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The prognosis of patients with acute necrotizing pancreatitis is mostly influenced by infection, thus the role of prophylaxis of infectious complications in severe acute pancreatitis (SAP) still remains a debatable issue. AIM: The aim of the study was to assess the efficacy of prophylactic antibiotic treatment comparing rates of infectious complications, mean hospital stay, necessity of surgical treatment and mortality in two groups of patients with large pancreatic necrosis in SAP. METHODS: Thirty five patients with SAP with CT or/and autopsy verified large pancreatic necrosis (> 30% of pancreatic tissue) were enrolled into the study. The patients were randomized either into the prophylactic (P) or into the therapeutic (T) group. In the P-group, ciprofloxacin (200 mg BID) and metronidazol (500 mg TID) or meropenem (500 mg TID) was administrated for 10 days. In the T-group, the patients received the same antibiotics only in the case of confirmed infectious complications (infected necrosis, abscess, urinary infection, pneumonia, etc.). Results are summarized in the table. CONCLUSIONS: Neither the rate of infectious complications nor mortality were reduced significantly by prophylactic antibiotic treatment in patients with large pancreatic necrosis.