View clinical trials related to Acute Pancreatitis.
Filter by:WATERFALL is an investigator-initiated international multicenter open-label randomized clinical trial comparing aggressive versus moderate fluid resuscitation in acute pancreatitis. The main outcome variable will be the proportion of patients with moderate-to-severe AP. Aggressive fluid resuscitation will consist in Lactated Ringer Solution (LR) 20 ml/kg bolus (administered over 2 hours) followed by LR 3 ml/kg/h and moderate a LR bolus 10 ml/kg in case of hypovolemia or no bolus in patients with normal volemia, followed by LR 1.5 ml/kg/h. The patients will be assessed at 3 (±1), 12 (±4), 24 (±4), 48 (±4) and 72 (±4) hours from recruitment, and fluid resuscitation will be adjusted to the patient´s clinical and analytical status according to a protocol. Subgroup analysis will include patients with systemic inflammatory response syndrome (SIRS) at admission, with persistent (>48h) SIRS and with hypovolemia at admission. Based on available data (Sternby et al, Ann Surg 2019) we expect a 35% incidence of moderate to severe AP in the moderate arm. Sample sizes of 372 per arm of treatment (744 patients) achieve 80% power to detect a difference of 10% between the treatment arms at a significance level (alpha) of 0.05 using a two-sided z-testNA, assuming a 10% dropout. These results assume that 3 sequential tests are made using the O'Brien-Fleming spending function to determine the test boundaries. All analyses will be performed on an intention-to-treat basis. The trial could be stop early for efficacy (primary end-point) if the observed two-sided P value is <0.0002 at the first interim analysis (after 1/3 of patients have been enrolled) or is <0.012 at second interim analysis (after 2/3 of patients have been enrolled), favoring aggressive fluid resuscitation. At final analysis, the hypothesis that the incidence of moderate-to-severe pancreatitis is similar in the two treatment arms will be rejected if p<0.046
This is a prospective, descriptive, observational research study designed to observe and document the clinical practice by domain experts, and how the knowledge of new findings that are published in the medical literature affect clinical decision making. The study will evaluate risk factors and co-variants, including genetic variants that are associated with disease progression such as pain, inflammation, organ dysfunction, disability and quality of life.
This will be a phase 2, single-center, unblinded randomized controlled pilot trial of two arms comparing opioid-sparing analgesia to the current Boston Children's Hospital institutional practice which has been reported to predominantly include administration of opioids as a first-line analgesic to pediatric patients who present to the emergency department with a diagnosis of acute pancreatitis (AP). This is a pilot trial for which many outcomes have not previously been studied in the pediatric AP population. The focus of this investigation will be to investigate the magnitude and variability of effect sizes for designing a future multi-center, double-blinded randomized controlled trial.
This study will compare pain management strategies for patients hospitalized with acute pancreatitis. Standard of care pain management will be compared to standard of care plus intravenous ketorolac.
In abdomen, the pancreas as a gland is involved in the digestive and endocrine system by secreting digestive enzymes and insulin. Acute pancreatitis (AP) is a common inflammatory condition of the pancreas with symptoms of sudden abdominal pain and high temperature which may develop to severe complications in some patients. The incidence of AP was roughly 33.74 cases per 100, 000 person-years around the world but varies in different regions which America has the highest incidence of 58.20 cases per 100 000 person-years. There are very few studies published on AP in China, while Japanese national survey in 2011 estimated an incidence rate of 49.4 per 100,000 population and a study in Taiwan showed an annual average incidence of 36.9 per 100,000 persons with a slight change over ten years. In most cases, patient with AP will start to recover within a week, but the patient quality of life (QoL) is still a big concern for disease management. It quantitatively measures the physical, mental and social wellbeing of individuals or their life satisfaction by questionnaires or surveys. Although very few studies have demonstrated the effect of AP on patient QoL, there is accumulating evidence to show its importance. Some studies reported no differences in QoL between AP patients and age-matched healthy people, whereas others showed QoL was significantly impaired due to AP. A large population-based follow-up study is needed to evaluate the impact of acute pancreatitis on quality of life. In addition, as the population investigated in most research was European based, the QoL evaluation of patients after AP among the Chinese population is also essential.
The overall goal of this ongoing registry study is to optimize initial evaluation and treatment of patients with AP according to recommended guidelines, the Methodist Acute Pancreatitis Protocol (MAPP), which were implemented in January 2015.
Cardiovascular system involvement with acute pancreatitis has been described before in the form of ECG changes and echocardiographic findings. However the correlation between these changes and the outcome of acute pancreatitis has not been and whether they can be used to predict mortality in these patients has been controversial.In the current study our aim is to detect echocardioghraphic and ECG changes in acute pancreatitis and investigate the significance of these changes on prognosis.
This is a phase I/II clinical trial assessing the tolerability and efficacy of CM4620 in children and young adults with acute pancreatitis caused by asparaginase. The tolerability of CM4620 when given to patients receiving frontline chemotherapy will be determined. The effectiveness in reducing the severity of pancreatitis will be estimated. Primary Objectives To assess the safety of CM4620 administration in children and young adults with asparaginase associated pancreatitis (AAP). To profile dose-limiting toxicities and responses of the patients treated in the dose-finding phase. To estimate the efficacy of CM4620 to prevent pseudocyst or necrotizing pancreatitis in children with AAP. Secondary Objectives To determine the effect of CM4620 on the incidence of severe pancreatitis To determine the effect of CM4620 on the incidence of Systemic Inflammatory Response Syndrome (SIRS).
The objective of the study is to classify and carry out a quantitative analysis of the different bacterial species present in the intestinal microbiota of patients with acute pancreatitis and determine if there are significant differences regarding healthy controls. At the same time, the investigators pretend to determine if there are differences according to the etiology and severity of the disease and if the disregulation is temporary or is maintained after one month of discharge. To carry out this purpose, the investigators have designed a prospective and multicentre observational study where samples of feces and saliva of patients admitted for acute pancreatitis of different etiologies and severity will be analyzed.
Authors design a prospective, longitudinal, descriptive study to identify the findings of thoracic point-of-care ultrasound in patients with acute pancreatitis. Patients will be included in the study since August through December 2019, admitted to the University Hospital, "Dr. José E. González", Universidad Autonoma de Nuevo León. These patients will undergo a pulmonary and vena cava ultrasound at admission, at 24 and 48 hours. The authors will describe findings of pulmonary ultrasound and their correlation with severity in patients with acute pancreatitis of all etiologies. The authors will analyze variables such Systemic inflammatory response syndrome, severity according to the revised Atlanta criteria (2012), and systemic complications.