Fluid hydration to prevent post-ERCP pancreatitis in average- to high-risk patients receiving prophylactic rectal NSAIDs (FLUYT trial): Study protocol for a randomized controlled trial

Background: Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication of ERCP and may run a severe course. Evidence suggests that vigorous periprocedural hydration can prevent PEP, but studies to date have significant methodological drawbacks. Importantly, evidence for its added value in patients already receiving prophylactic rectal non-steroidal anti-inflammatory drugs (NSAIDs) is lacking and the cost-effectiveness of the approach has not been investigated. We hypothesize that combination therapy of rectal NSAIDs and periprocedural hydration would significantly lower the incidence of post-ERCP pancreatitis compared to rectal NSAIDs alone in moderate- to high-risk patients undergoing ERCP. Methods: The FLUYT trial is a multicenter, parallel group, open label, superiority randomized controlled trial. A total of 826 moderate- to high-risk patients undergoing ERCP that receive prophylactic rectal NSAIDs will be randomized to a control group (no fluids or normal saline with a maximum of 1.5 mL/kg/h and 3 L/24 h) or intervention group (lactated Ringer's solution with 20 mL/kg over 60 min at start of ERCP, followed by 3 mL/kg/h for 8 h thereafter). The primary endpoint is the incidence of post-ERCP pancreatitis. Secondary endpoints include PEP severity, hydration-related complications, and cost-effectiveness. Discussion: The FLUYT trial design, including hydration schedule, fluid type, and sample size, maximize its power of identifying a potential difference in post-ERCP pancreatitis incidence in patients receiving prophylactic rectal NSAIDs

Palaeomagnetism of Archaean rocks of the Onverwacht Group, Barberton Greenstone Belt (southern Africa): Evidence for a stable and potentially reversing geomagnetic field at ca. 3.5 Ga

Palaeomagnetic data from the Palaeoarchaean Era (3.2–3.6 Ga) have the potential to provide us with a great deal of information about early conditions within, and processes affecting, the Earth's core, mantle, and surface environment. Here we present new data obtained from some of the oldest palaeomagnetic recorders in the world: igneous and sedimentary rocks from the Onverwacht Group of the Barberton Greenstone Belt (Kaapvaal Craton, southern Africa). Our palaeomagnetic measurements strengthen a recently published positive conglomerate test (Y. Usui, J.A. Tarduno, M. Watkeys, A. Hofmann and R.D. Cottrell, 2009) and our new U–Pb date constrains the conglomerate to older than 3455 ± 8 Ma. The new palaeomagnetic data from other units are nontrivial to interpret and are of uncertain reliability when taken individually; similar, we argue, to all other published palaeomagnetic data of this age. Nonetheless, four poles (two new, two derived from published data) produced from high temperature components of magnetisation recorded in the Komati, Noisy, and Hooggenoeg formations exhibit considerably improved clustering when their directions are corrected for differences in attitude resulting from a large fold structure dated at 3.23 Ga. On the basis of this enhanced consistency in stratigraphic coordinates, the positive conglomerate test, and the absence of any clear indications of their remagnetisation from comparison with younger poles, we argue that these are the most trustworthy palaeomagnetic results yet produced from any rocks of Palaeoarchaean age. When taken in conjunction with published data, the new results present the most compelling evidence to date that the Earth had a stable geomagnetic field at ca. 3.5 Ga in addition to presenting tentative evidence that it was undergoing polarity reversals. The data do not appear to support a claim, made previously from Palaeoarchean palaeomagnetic data from the Pilbara Craton (Y. Suganuma, Y. Hamano, S. Niitsuma, M. Hoashi, T. Hisamitsu, N. Niitsuma, K. Kodama and M. Nedachi, 2006), of extremely rapid latitudinal plate motion during this period. Finally, when compared with similarly aged data from the Pilbara Craton (Western Australia), the new data do not rule out the hypothesis that the two cratons were conjoined at this point in their history in the supercraton Vaalbara

Changing Dutch approach and trends in short-term outcome of periviable preterms

Item does not contain fulltextBACKGROUND: In 2006, the Dutch guideline for active treatment of extremely preterm neonates advised to lower the gestational age threshold for active intervention from 26 0/7 to 25 0/7 weeks gestation. OBJECTIVE: To evaluate the association between the guideline modification and early neonatal outcome. DESIGN: National cohort study, using prospectively collected data from The Netherlands Perinatal Registry. PATIENTS: The study population consisted of 9713 infants with a gestational age between 24 0/7 and 29 6/7 weeks, born between 2000 and 2011. Three gestational age subgroups were analysed: 24 0/7 to 24 6/7 weeks (n=269), 25 0/7 to 25 6/7 weeks (n=852) and 26 0/7 to 29 6/7 weeks (n=8592). MAIN OUTCOME MEASURES: Neonatal intensive care unit (NICU) admission, live births, neonatal in-hospital mortality, morbidity and favourable outcome (no mortality or morbidity) before (2000-2005; period 1) and after (2007-2011; period 2) introduction of the modified guideline, using chi(2) tests and univariable and multivariable logistic regression analyses. RESULTS: In the second period, the proportion of live births and NICU admissions increased and the proportion of neonatal and in-hospital mortality decreased significantly in all subgroups. Morbidity in surviving infants of 25 weeks increased significantly, although the association between guideline modification and morbidity became non-significant after case-mix adjustment. Overall, favourable outcome did not change significantly after guideline modification in all subgroups when adjusted for variation in case-mix. CONCLUSIONS: Overall, the trend in mortality gradually declined at all gestational ages, starting before 2006. This suggests that the guideline modification was a formalisation of already existing daily practice

The value of the neutrophil-lymphocyte count ratio in the diagnosis of sepsis in patients admitted to the Intensive Care Unit: A retrospective cohort study

Contains fulltext : 202166.pdf (publisher's version ) (Open Access

Routine Monitoring of Quality of Life for Patients with Breast Cancer: An Acceptability and Field Test

Clinical Oncolog

Monitoring Quality of Life (QoL) and Distress in Patients With Breast Cancer: The Care Notebook Study

Biological, physical and clinical aspects of cancer treatment with ionising radiatio

Performance and usability evaluation of a mobile health data capture application in clinical cancer trials follow-up

Mobile health data capture applications (mHDA’s) may improve communication between healthcare providers and patients. However, there is limited literature about the use of mHDA’s facilitating clinical trials. In this study, the effectiveness of an application, supporting follow-up visits of cancer trial participants was investigated. Twenty participants were provided with an e-questionnaire via the mHDA. Participants rated the usability of the application as high performing (mean Systems Usability Scale 87 points). The research team rated the mHDA as highly applicable and efficient in preparing visits. Anamnesis, physical examination and agreement on further policy were performed within an average of 31 min

Fluid hydration to prevent post-ERCP pancreatitis in average- to high-risk patients receiving prophylactic rectal NSAIDs (FLUYT trial): study protocol for a randomized controlled trial

Contains fulltext : 190882.pdf (publisher's version ) (Open Access)BACKGROUND: Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication of ERCP and may run a severe course. Evidence suggests that vigorous periprocedural hydration can prevent PEP, but studies to date have significant methodological drawbacks. Importantly, evidence for its added value in patients already receiving prophylactic rectal non-steroidal anti-inflammatory drugs (NSAIDs) is lacking and the cost-effectiveness of the approach has not been investigated. We hypothesize that combination therapy of rectal NSAIDs and periprocedural hydration would significantly lower the incidence of post-ERCP pancreatitis compared to rectal NSAIDs alone in moderate- to high-risk patients undergoing ERCP. METHODS: The FLUYT trial is a multicenter, parallel group, open label, superiority randomized controlled trial. A total of 826 moderate- to high-risk patients undergoing ERCP that receive prophylactic rectal NSAIDs will be randomized to a control group (no fluids or normal saline with a maximum of 1.5 mL/kg/h and 3 L/24 h) or intervention group (lactated Ringer's solution with 20 mL/kg over 60 min at start of ERCP, followed by 3 mL/kg/h for 8 h thereafter). The primary endpoint is the incidence of post-ERCP pancreatitis. Secondary endpoints include PEP severity, hydration-related complications, and cost-effectiveness. DISCUSSION: The FLUYT trial design, including hydration schedule, fluid type, and sample size, maximize its power of identifying a potential difference in post-ERCP pancreatitis incidence in patients receiving prophylactic rectal NSAIDs. TRIAL REGISTRATION: EudraCT: 2015-000829-37 . Registered on 18 February 2015. ISRCTN: 13659155 . Registered on 18 May 2015