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Pancreatic stone protein (PSP) and pancreatitis-associated protein (PAP): a protocol of a cohort study on the diagnostic efficacy and prognostic value of PSP and PAP as postoperative markers of septic complications in patients undergoing abdominal surgery (PSP study).

ABSTRACT: Major abdominal surgery leads to a postoperative systemic inflammatory response, making it difficult to discriminate patients with systemic inflammatory response syndrome from those with a beginning postoperative infectious complication. At present, physicians have to rely on their clinical experience to differentiate between the two. Pancreatic stone protein (PSP) and pancreatitis-associated protein (PAP), both secretory proteins produced by the pancreas, are dramatically increased during pancreatic disease and have been shown to act as acute-phase proteins. Increased levels of PSP have been detected in polytrauma patients developing sepsis and PSP has shown a high diagnostic accuracy in discriminating the severity of peritonitis and in predicting death in intensive care unit patients. However, the prognostic value of PSP/PAP for infectious complications among patients undergoing major abdominal surgery is unknown.160 patients undergoing major abdominal surgery will be recruited preoperatively. On the day before surgery, baseline blood values are attained. Following surgery, daily blood samples for measuring regular inflammatory markers (c-reactive protein, procalcitonin, interleukin-6, tumour necrosis factor-? and leucocyte counts) and PSP/PAP will be acquired. PSP/PAP will be measured using a validated ELISA developed in our research laboratory. Patient's discharge marks the end of his/her trial participation. Complication grade including mortality and occurrence of infectious postoperative complications according to validated diagnostic criteria will be correlated with PSP/PAP values. Total intensive care unit days and total length of stay will be recorded as further outcome parameters.The PSP trial is a prospective monocentric cohort study evaluating the prognostic value of PSP and PAP for postoperative infectious complications. In addition, a comparison with established inflammatory markers in patients undergoing major abdominal surgery will be performed to help evaluate the role of these proteins in predicting and diagnosing infectious and other postoperative complications.KEKZH-Nr. STV 11-2009.ClinicalTrials.gov: NCT01258179.

SUBMITTER: Fisher OM

PROVIDER: S-EPMC3948573 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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Pancreatic stone protein (PSP) and pancreatitis-associated protein (PAP): a protocol of a cohort study on the diagnostic efficacy and prognostic value of PSP and PAP as postoperative markers of septic complications in patients undergoing abdominal surgery (PSP study).

Fisher Oliver Maximilian OM Oberkofler Christian Eugen CE Raptis Dimitri Aristotle DA Soll Christopher C Béchir Markus M Schiesser Marc M Graf Rolf R

BMJ open 20140306 3

<h4>Introduction</h4>Major abdominal surgery leads to a postoperative systemic inflammatory response, making it difficult to discriminate patients with systemic inflammatory response syndrome from those with a beginning postoperative infectious complication. At present, physicians have to rely on their clinical experience to differentiate between the two. Pancreatic stone protein (PSP) and pancreatitis-associated protein (PAP), both secretory proteins produced by the pancreas, are dramatically i ...[more]

PMID: 24604486

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Project description:Background:Postoperative pulmonary complications (PPCs) contribute significantly to overall postoperative morbidity and mortality. In abdominal surgery, PPCs remain frequent. The study aimed to analyze the profile and outcomes of PPCs in patients submitted to abdominal surgery and admitted in a Portuguese polyvalent intensive care unit. Methods:From January to December 2017 in the polyvalent intensive care unit of Hospital Garcia de Orta, Almada, Portugal, we conducted a retrospective, observational study of inpatients submitted to urgent or elective abdominal surgery who had severe PPCs. We evaluated the perioperative risk factors and associated mortality. Logistic regression was performed to find which perioperative risk factors were most important in the occurrence of PPCs. Results:Sixty patients (75% male) with a median age of 64.5 [47-81] years who were submitted to urgent or elective abdominal surgery were included in the analysis. Thirty-six patients (60%) developed PPCs within 48?h and twenty-four developed PPCs after 48?h. Pneumonia was the most frequent PPC in this sample. In this cohort, 48 patients developed acute respiratory failure and needed mechanical ventilation. In the emergency setting, peritonitis had the highest rate of PPCs. Electively operated patients who developed PPCs were mostly carriers of digestive malignancies. Thirty-day mortality was 21.7%. The risk of PPCs development in the first 48?h was related to the need for neuromuscular blocking drugs several times during surgery and preoperative abnormal arterial blood gases. Median abdominal surgical incision, long surgery duration, and high body mass index were associated with PPCs that occurred more than 48?h after surgery. The American Society of Anesthesiologists physical status score 4 and COPD/Asthma determined less mechanical ventilation needs since they were preoperatively optimized. Malnutrition (low albumin) before surgery was associated with 30-day mortality. Conclusion:PPCs after abdominal surgery are still a major problem since they have profound effects on outcomes. Our results suggest that programs before surgery, involve preoperative lifestyle changes, such as nutritional supplementation, exercise, stress reduction, and smoking cessation, were an effective strategy in mitigating postoperative complications by decreasing mortality.

Project description:IntroductionDiabetes has an increasing worldwide prevalence. It is known to be a predisposing factor for postoperative complications. Preoperative glycaemic control strategies should be pursued as glycaemic control could serve as a modifiable risk factor. Glycated haemoglobin (HbA1c), a marker of 3-month average glycaemic control, has been shown in meta-analyses to predict postoperative complications in cardiothoracic, bariatric and orthopaedic surgery. However, there is no meta-analysis in the major abdominal surgery population, in whom morbidity may be higher due to the nature of the surgery. Understanding the association between HbA1c and postoperative complications could help in preoperative risk prognostication, counselling and glycaemic target selection. The aim of this systematic review and meta-analysis is to evaluate all evidence on the association between preoperative HbA1c and postoperative complications in elective major abdominal surgery, and to investigate the threshold HbA1c level before postoperative complication rates increase.Methods and analysisThis review will be performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. PubMed, Embase, Cochrane Central Register of Controlled Trials, Google Scholar and China National Knowledge Infrastructure will be searched for all original studies. Study selection, data extraction, risk of bias and quality assessment will be conducted by two independent reviewers. The primary outcome is the association between preoperative HbA1c and major postoperative complications (Clavien Dindo 3-5), and the secondary outcome is the association between HbA1c and overall postoperative complications. Data management and synthesis will be performed using Microsoft Excel and Stata to derive pool estimates.Ethics and disseminationNo ethics approval is required as only secondary data will be used. Findings will be disseminated through peer-reviewed journals and conference presentations.Prospero registration numberCRD42020167347.

Project description:BackgroundPostoperative pulmonary complications (PPCs) have an impact on the recovery of adults after surgery. It is therefore important to establish whether preoperative respiratory rehabilitation can decrease the risk of PPCs and to identify adults who might benefit from respiratory rehabilitation.ObjectivesOur primary objective was to assess the effectiveness of preoperative inspiratory muscle training (IMT) on PPCs in adults undergoing cardiac or major abdominal surgery. We looked at all-cause mortality and adverse events.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 10), MEDLINE (1966 to October 2014), EMBASE (1980 to October 2014), CINAHL (1982 to October 2014), LILACS (1982 to October 2014), and ISI Web of Science (1985 to October 2014). We did not impose any language restrictions.Selection criteriaWe included randomized controlled trials that compared preoperative IMT and usual preoperative care for adults undergoing cardiac or major abdominal surgery.Data collection and analysisTwo or more review authors independently identified studies, assessed trial quality, and extracted data. We extracted the following information: study characteristics, participant characteristics, intervention details, and outcome measures. We contacted study authors for additional information in order to identify any unpublished data.Main resultsWe included 12 trials with 695 participants; five trials included participants awaiting elective cardiac surgery and seven trials included participants awaiting elective major abdominal surgery. All trials contained at least one domain judged to be at high or unclear risk of bias. Of greatest concern was the risk of bias associated with inadequate blinding, as it was impossible to blind participants due to the nature of the study designs. We could pool postoperative atelectasis in seven trials (443 participants) and postoperative pneumonia in 11 trials (675 participants) in a meta-analysis. Preoperative IMT was associated with a reduction of postoperative atelectasis and pneumonia, compared with usual care or non-exercise intervention (respectively; risk ratio (RR) 0.53, 95% confidence interval (CI) 0.34 to 0.82 and RR 0.45, 95% CI 0.26 to 0.77). We could pool all-cause mortality within postoperative period in seven trials (431 participants) in a meta-analysis. However, the effect of IMT on all-cause postoperative mortality is uncertain (RR 0.40, 95% CI 0.04 to 4.23). Eight trials reported the incidence of adverse events caused by IMT. All of these trials reported that there were no adverse events in both groups. We could pool the mean duration of hospital stay in six trials (424 participants) in a meta-analysis. Preoperative IMT was associated with reduced length of hospital stay (MD -1.33, 95% CI -2.53 to -0.13). According to the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) Working Group guidelines for evaluating the impact of healthcare interventions, the overall quality of studies for the incidence of pneumonia was moderate, whereas the overall quality of studies for the incidence of atelectasis, all-cause postoperative death, adverse events, and duration of hospital stay was low or very low.Authors' conclusionsWe found evidence that preoperative IMT was associated with a reduction of postoperative atelectasis, pneumonia, and duration of hospital stay in adults undergoing cardiac and major abdominal surgery. The potential for overestimation of treatment effect due to lack of adequate blinding, small-study effects, and publication bias needs to be considered when interpreting the present findings.

Project description:Importance:Body mass index (BMI) has been the most common obesity measure to assess perioperative risk; however, cardiometabolic risk is associated with the burden of visceral fat. Definitive evidence on the association of visceral fat measures, such as waist circumference and waist-to-hip ratio (WHR), with postoperative complications is lacking. Objective:To compare the value of waist circumference with the value WHR and BMI in predicting adverse outcomes, including major septic complications and persistent disability, following major abdominal surgery. Design, Setting, and Participants:This planned secondary analysis of the Restrictive vs Liberal Fluid Therapy for Major Abdominal Surgery (RELIEF) randomized clinical trial took place at 47 centers in 7 countries between October 2013 and September 2016, with 90-day follow-up. A total of 2954 adult RELIEF participants were coenrolled in this secondary analysis. Data analysis took place from December 2018 to September 2019. Exposures:Waist circumference, WHR, and BMI measurements. Main Outcomes and Measures:The primary outcomes were 30-day major septic complications and 90-day persistent disability or death. Results:Of 2954 eligible participants, 2755 were included (mean [SD] age, 65.9 [12.9] years; 1426 [51.8%] men) in the final analysis. A total of 564 participants (20.6%) experienced at least 1 major septic complication within 30 days after surgery (sepsis, 265 [9.7%]; surgical site infection, 409 [14.9%]; anastomotic leak, 78 [2.8%]; pneumonia, 104 [3.8%]). Waist circumference had a statistically significantly larger odds ratio (OR) and discrimination indices as well as a smaller prediction error than WHR or BMI for 30-day major septic complications or death (waist circumference: OR, 1.44; 95% CI, 1.28-1.62; P < .001; area under the receiver operating characteristic curve, 0.641; net reclassification index, 0.266; integrated discrimination improvement [score × 104], 152.98; Brier score, 0.162; WHR: OR, 1.15; 95% CI, 1.03-1.28; P = .01; area under the receiver operating characteristic curve, 0.621; net classification index, 0.199; integrated discrimination improvement [score × 104], 28.47; Brier score, 0.164; BMI: OR, 1.33; 95% CI, 1.17-1.50; P < .001; area under the receiver operating characteristic curve, 0.629; net reclassification index, 0.205; integrated discrimination improvement [score × 104], 85.61; Brier score, 0.163) but not for any other outcomes. Conclusions and Relevance:In this secondary analysis of the RELIEF randomized clinical trial, waist circumference was observed to be superior to other adiposity indices in predicting 30-day major septic complications alone or in conjunction with death following elective major abdominal surgery. Findings suggest that waist circumference is a useful adiposity measure that should be incorporated in preoperative risk assessment for such complications. Trial Registration:ClinicalTrials.gov identifier: NCT01424150.

Dataset Information

Pancreatic stone protein (PSP) and pancreatitis-associated protein (PAP): a protocol of a cohort study on the diagnostic efficacy and prognostic value of PSP and PAP as postoperative markers of septic complications in patients undergoing abdominal surgery (PSP study).

Publications

Pancreatic stone protein (PSP) and pancreatitis-associated protein (PAP): a protocol of a cohort study on the diagnostic efficacy and prognostic value of PSP and PAP as postoperative markers of septic complications in patients undergoing abdominal surgery (PSP study).

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