P1151CLINICAL OUTCOMES IN REMOTE PATIENT MONITORING IN AUTOMATED PERITONEAL DIALYSIS : A COLOMBIAN EXPERIENCE

Background and Aims Patients with remote monitoring are followed-up daily by clinical teams, allowing early detection and correction of problems, which could result in improvements in therapy outcomes. Aims: To evaluate the association between Remoted Patient Monitoring (RPM) program and clinical outcomes (technique failure and peritonitis rates). Method A historical, multicenter, observational cohort study in Automatized Peritoneal Dialysis (APD) prevalent patients, included between October 1, 2016, and June 30, 2017 with follow-up until June 30, 2018, at Renal Therapy Services (RTS) network. Patients were older than 18 years, divided into two cohorts based on the RPM use: 1) APD-RPM cohort: patients using the HomeChoice Claria® device with Sharesource® technology (Baxter Healthcare, Deerfield, USA) and 2) APD-Without RPM cohort: patients using APD systems HomeChoice Legacy® without RPM. Socio-demographic and clinical characteristics of all patient were summarized descriptively. Propensity score matching 1:1 was used. Results 558 patients met the inclusion criteria for data analysis. The mean age was 54 years, 40% were female, 26% had APD RPM, see Table 1. After propensity score matching, APD therapy with RPM (n=148) as compared to APD-Without RPM (n=148) was associated with significant reduction in technique failure, IRR= 0.46 95% CI: [0.24 - 0 .89], and a trend in peritonitis rate reduction, IRR= 0.87 [0.41 - 1.00], P= 0.051, see table 2. Main reasons of technique failure are presented in table 3. Conclusion The use of RPM program in APD patients is associated with lower technique failure rate, supporting the role of this technology as performance enhancer.

PARE0018 WEBSITE FOR PARENTS OF CHILDREN WITH JUVENILE IDIOPATHIC ARTHRITIS REDUCES PARENTING STRESS.

Background:Having a child with JIA presents many challenges. Many parents experience considerable stress. Parental distress and functioning have been found to be related to child outcomes (Cousino, 2013), therefore interventions that help parents to manage their child’s illness are important for both parents and child. We developed a website for parents of children with newly diagnosed JIA to help increase parental confidence in managing their child’s arthritis and reduce parenting stress.Objectives:To evaluate the efficacy of a web-based tool ‘WebParC’ for parents of children with JIA.Methods:Design:Multi-centre randomised controlled trial conducted in 16 tertiary paediatric rheumatology centres in England.Participants:Parent(s) of children aged ≤12 years, diagnosed with JIA within the previous six months.Procedures:Parents were enrolled when they attended the rheumatology service and were randomised by household to either the intervention arm (I) who were given access to the website in addition to their child’s standard care or the control arm (C) who received standard care alone.The primary outcome was parenting stress, measured with the Pediatric Inventory for Parents (PIP) (Streisand, 2001), which parents completed prior to randomisation and at 4-months and 12-months post randomisation.Website content was developed by a multidisciplinary team including rheumatology, physiotherapy, ophthalmology, social work, podiatry, occupational therapy, clinical and health psychology along with parents of children with JIA. It includes information about JIA and its treatment plus a ‘toolkit’ for parents. The toolkit is based on cognitive-behavioural principles to develop skills for managing JIA-related issues.Analysis:We conducted linear mixed models to examine the main effect of trial arm (I vs C), main effect of time (between 4M and 12M scores), and interaction between trial arm and time on PIP scores, after controlling for baseline scores.Results:A total of 220 parents (183 mothers, 37 fathers) of 203 children were randomised, 106 intervention and 114 controls. Parents mean (SD) age was 36.5 (6.5). Their children with JIA were mostly female (137/203, 67.5%), mean (SD) age of 6.1 (3.4) years. There were 107 (52.7%) with oligoarthritis, 65 (32%) polyarthritis, 8 (3.9%) systemic and 23 (11.3%) other JIA subtypes. Seventy (34.5%) were prescribed methotrexate.Trial arms did not differ significantly at baseline except for parent education, which was higher in the intervention group and was controlled for in the analysis.Follow-up assessments were completed by 133 (I60, C73) at 4M and 124 (I58, C66) at 12M.We found significant main effects of trial arm on PIP Difficulty (p=0.022, Control (Mean=93.62, SE=2.717) > Intervention (Mean=84.23, SE=3.025)) and PIP Frequency (p= 0.008, Control (Mean=95.78, SE=2.400) > Intervention (Mean=86.23, SE=2.622), with Controls reporting significantly greater frequency and difficulty of stressful events than the Intervention group (Fig 1).Conclusion:This trial found that a website for parents of children with JIA can help to reduce parenting stress.References:[1]Cousino MK, Hazen RA. J Pediatr Psychol 2013; 38(8):809-28[2]Streisand R, Braniecki S, Tercyak KP, Kazak AE. J Pediatr Psychol 2001; 26(3):155-62.Acknowledgments:We thank all parent participants, the health professionals and parents who developed website content and the clinical teams who supported recruitment.Funded by NIHR RfPB.Disclosure of Interests:Kathleen Mulligan: None declared, Shashivadan Hirani: None declared, Sally Clarke: None declared, Neil Evans: None declared, Chris Flood: None declared, Jo Taylor: None declared, Lucy Wedderburn Speakers bureau: Pfizer, Stanton Newman Grant/research support from: Yes Baxter Healthcare Educational Grants not in relation to rheumatology, Speakers bureau: Yes Baxter Healthcare and Merke Sharp and Dome

Standardised neonatal parenteral nutrition formulations – Australasian Neonatal Parenteral Nutrition Consensus update 2017

Background: The first consensus standardised neonatal parenteral nutrition formulations were implemented in many neonatal units in Australia in 2012. The current update involving 49 units from Australia, New Zealand, Singapore, Malaysia and India was conducted between September 2015 and December 2017 with the aim to review and update the 2012 formulations and guidelines. Methods: A systematic review of available evidence for each parenteral nutrient was undertaken and new standardised formulations and guidelines were developed. Results: Five existing preterm Amino acid-Dextrose formulations have been modified and two new concentrated Amino acid-Dextrose formulations added to optimise amino acid and nutrient intake according to gestation. Organic phosphate has replaced inorganic phosphate allowing for an increase in calcium and phosphate content, and acetate reduced. Lipid emulsions are unchanged, with both SMOFlipid (Fresenius Kabi, Australia) and ClinOleic (Baxter Healthcare, Australia) preparations included. The physicochemical compatibility and stability of all formulations have been tested and confirmed. Guidelines to standardise the parenteral nutrition clinical practice across facilities have also been developed. Conclusions: The 2017 PN formulations and guidelines developed by the 2017 Neonatal Parenteral Nutrition Consensus Group offer concise and practical instructions to clinicians on how to implement current and up-to-date evidence based PN to the NICU population.

Standardised neonatal parenteral nutrition formulations – Australasian Neonatal Parenteral Nutrition Consensus update 2017

Background: The first consensus standardised neonatal parenteral nutrition formulations were implemented in many neonatal units in Australia in 2012. The current update involving 49 units from Australia, New Zealand, Singapore, Malaysia and India was conducted between September 2015 and December 2017 with the aim to review and update the 2012 formulations and guidelines. Methods: A systematic review of available evidence for each parenteral nutrient was undertaken and new standardised formulations and guidelines were developed. Results: Five existing preterm Amino acid-Dextrose formulations have been modified and two new concentrated Amino acid-Dextrose formulations added to optimise amino acid and nutrient intake according to gestation. Organic phosphate has replaced inorganic phosphate allowing for an increase in calcium and phosphate content, and acetate reduced. Lipid emulsions are unchanged, with both SMOFlipid (Fresenius Kabi, Australia) and ClinOleic (Baxter Healthcare, Australia) preparations included. The physicochemical compatibility and stability of all formulations have been tested and confirmed. Guidelines to standardise the parenteral nutrition clinical practice across facilities have also been developed. Conclusions: The 2017 PN formulations and guidelines developed by the 2017 Neonatal Parenteral Nutrition Consensus Group offer concise and practical instructions to clinicians on how to implement current and up-to-date evidence based PN to the NICU population.

Η πιθανή ευεργετική δράση αυξητικών παραγόντων στην επούλωση πειραματικά δημιουργηθείσας και εκταμθείσας ενδομητριωσικής εστίας στο παχύ έντερο επιμύων

Σκοπός: Η αξιολόγηση της πιθανής ευεργετικής δρασης του πλάσματος εμπλουτισμένου με αιμοπετάλια (Platelet rich plasma-PRP) και του συγκολλητικού παράγοντα ινώδους (TISSEEL, Baxter Healthcare Corporation, Deerfield, IL) στην επούλωση του εντέρου μετά το “ξύρισμα”-εφαπτομενική εκτομή πειραματικά επαγόμενης ενδομητριωτικής εστίας παχέος εντέρου. Σχεδίαση μελέτης: Τυφλή τυχαιοποιημένη πειραματική μελέτη. Ζώα: Τριάντα θήλεις αρουραίοι Sprague-Dawley (SD). Παρεμβάσεις: Επαγωγή πειραματικής ενδομητρίωσης του παχέος εντέρου με αυτόλογη μεταμόσχευση ενδομητρικού ιστού σε όλα τα ζώα (1η χειρουργική επέμβαση). Τριάντα αρουραίοι τυχαιοποιήθηκαν σε 1 από τις 3 ομάδες σύμφωνα με την θεραπευτική παρέμβαση: PRP (ομάδα I, ν = 10), TISSEEL (ομάδα II, n = 10) ή κανένας παράγοντας (ομάδα III, ν=10) εφαρμόστηκαν στην “ξυρισμένη” επιφάνεια του παχέος εντέρου (2η χειρουργική επέμβαση). Μετρήσεις και κύρια αποτελέσματα: Η ενδομητρίωση του παχέος εντέρου επάχθηκε με επιτυχία σε όλα τα ζώα. Τέσσερις ημέρες μετά τη 2η χειρουργική επέμβαση, τα ζώα υπέστησαν ευθανασία και πραγματοποιήθηκε ιστολογική εξέταση. Η ιστολογική εξέταση έδειξε ότι σε σύγκριση με την ομάδα ελέγχου, η εναπόθεση κολλαγόνου βρέθηκε σε σημαντικά υψηλότερη έκφραση τόσο στην ομάδα του PRP όσο και σε αυτή του TISSEEL (p = .011 και p = .011, αντίστοιχα). Η διαταραχή της αρχιτεκτονικής των στιβάδων του παχεός εντέρου ήταν στατιστικά πιο έντονη στην ομάδα ελέγχου συγκριτικά με την ομάδα TISSEEL (p = .033) ενώ παρατηρήθηκε πιο εξεσημασμένος σχηματισμός νέων αιμοφόρων αγγείων στην ομάδα του TISSEEL σε σύγκριση με την ομάδα ελέγχου (p = .023). Δεν ανιχνεύθηκαν ιστολογικές ενδείξεις υπολειμματικής ή υποτροπιάζουσας νόσου. Συμπέρασμα: Τόσο η χρήση του PRP όσο και του TISSEEL φαίνεται να είναι ασφαλής και να σχετίζεται με βελτίωση της επούλωσης των ιστών μετά την αποψίλωση ενδομητριωσικής εστίας παχέος εντέρου, που αποδίδεται στην αυξημένη εναπόθεση κολλαγόνου, στη νεοαγγείωση και την προστασία της ακεραιότητας των στιβάδων του παχέος εντέρου. Στο πεδίο αυτό, κλινικές δοκιμές απαιτούνται για να επιβεβαιώσουν την αποτελεσματικότητα του PRP και του TISSEEL στην κλινική πράξη.

P118 A novel technique for repair of the vertebral artery during cranial surgery

ObjectivesTo demonstrate a novel/alternative technique for repair of the vertebral artery intraoperatively.DesignLeft-sided retromastoid craniotomy in one patient.SubjectsA 61-year-old male patient with meningioma in the foramen magnum encasing the vertebral artery on the left side.MethodsStandard retrosigmoid craniotomy performed with preservation of transverse and sigmoid sinuses. The dura was opened and the cerebellum was retracted with CSF release. The tumour was debulked gradually. The attempt to peel the tumour from the vertebral artery resulted in arterial bleeding. The hole in the artery was sealed using an N-hydroxysuccinimide functionalised polyethylene glycol-coated collagen patch (Hemopatch®, Baxter Healthcare Ltd) as an onlay, applying pressure for 2 minutes. Another patch was applied for further support and the artery checked for haemostasis. The dura was closed with 3–0 vicryl and Hemopatch® onlay after further tumour debulking.ResultsHaemostasis of the vertebral artery was achieved at 140 mmHg SBP and a catheter angiogram found no dissection or false lumen. The patient did not suffer postoperative haemorrhage and after three months of inpatient rehabilitation was discharged with significantly improved cranial nerve function. There was no CSF leak.ConclusionsHaemostasis was successfully achieved in the vertebral artery with this novel technique. It can prove to be important in such scenarios where direct cross-clamping and arterial repair is technically challenging and can lead to brainstem ischemia.

Effects of Conversion to a Bicarbonate/Lactate-Buffered, Neutral-PH, LOW-GDP PD Regimen in Prevalent PD: A 2-Year Randomized Clinical Trial

BackgroundThe use of pH-neutral peritoneal dialysis (PD) fluids low in glucose degradation products (GDP) may better preserve the peritoneal membrane and have fewer systemic effects. The effects of conversion from conventional to neutral-pH, low-GDP PD fluids in prevalent patients are unclear. Few studies on the role of neutral-pH, low-GDP PD have studied residual renal function, ultrafiltration, peritonitis incidence and technique failure, transport characteristics, and local and systemic markers of inflammation in prevalent PD patients.MethodsIn a multi-center open-label randomized clinical trial (RCT), we randomly assigned 40 of 78 stable continuous ambulatory PD (CAPD) and automated PD (APD) patients to treatment with bicarbonate/lactate, neutral-pH, low-GDP PD fluid (Physioneal; Baxter Healthcare Corporation, Deerfield, IL, USA) and compared them with 38 patients continuing their current standard lactate-buffered PD fluid (PDF) (Dianeal; Baxter Healthcare Corporation, Deerfield, IL, USA) during 2 years. Primary outcome was residual renal function (RRF) and ultrafiltration (UF) during peritoneal equilibration test (PET); peritonitis incidence was a secondary outcome. Furthermore, clinical parameters as well as several biomarkers in effluents and serum were measured.ResultsDuring follow-up, RRF did not differ between the groups. In the Physioneal group ultrafiltration (UF) during PET remained more or less stable (-20 mL [confidence interval (CI): -163.5 – 123.5 mL]; p = 0.7 over 24 months), whereas it declined in the Dianeal group (-243 mL [CI: -376.6 to -109.4 mL]; p < 0.0001 over 24 months), resulting in a difference of 233.7 mL [95% CI 41.0 – 425.5 mL]; p = 0.017 between the groups at 24 months. The peritonitis rate was lower in the Physioneal group: adjusted odds ratio (OR) 0.38 (0.15 – 0.97) p = 0.043. No differences were observed between the 2 groups in peritoneal adequacy or transport characteristics nor effluent markers of local inflammation (cancer antigen [CA]125, hyaluronan [HA], vascular endothelial growth factor [VEGF], macrophage chemo-attractant protein [MCP]-1, HA and transforming growth factor [TGF]β–1).ConclusionIn prevalent PD patients, our study did not find a difference in RRF after conversion from conventional to neutral-pH, low-GDP PD fluids, although there is a possibility that the study was underpowered to detect a difference. Decline in UF during standardized PET was lower after 2 years in the Physioneal group.

Compatibility of Meropenem with Different Commercial Peritoneal Dialysis Solutions

BackgroundIntraperitoneal administration of antimicrobial agents is recommended for the treatment of peritoneal dialysis (PD)-related peritonitis. For home-based antimicrobial therapy it is common to supply patients with PD fluid bags with admixed antibiotic. Thus, the compatibility of meropenem with different PD fluids (PDFs), namely Extraneal, Physioneal 1.36% and Physioneal 2.27% (all Baxter Healthcare Corp., Deerfield, IL, USA), was investigated under varying storage conditions.MethodsMeropenem (Venus Pharma, Werne, Germany) was stored at 6°C and 25°C over 14 days and at 37°C over 24 hours. Drug concentration over time was determined using high performance liquid chromatography, drug activity by a diffusion disk method, diluent stability by visual inspection and drug adsorption was calculated. Blank PD fluids and deionized water were used as comparator solutions.ResultsCompared to water, the stability of meropenem was minimally lower in Extraneal but markedly reduced in both Physioneal solutions. No significant drug adsorption was detected for any PDF investigated.ConclusionsMeropenem is stable and compatible with Extraneal and might be stored for up to a week at refrigeration temperature (6°C). A loss of ∼20% of meropenem after 2 days at room temperature should be considered. Mixed Physioneal appears not suitable for storage at any temperature after meropenem has been admixed. A considerable drug degradation due to the warming up to body temperature through heating plates should further be taken into account in clinical practice.

Pharmacokinetics of Intraperitoneal Daptomycin in Patients with Peritoneal Dialysis-Related Peritonitis

BackgroundAntibiotics are preferentially delivered via the peritoneal route to treat peritoneal dialysis-related peritonitis (PDRP) to ensure that maximal concentrations are delivered to the site of infection. Our study focused on the pharmacokinetics of daptomycin (DAP) administered via the intraperitoneal (IP) route in patients with PDRP.MethodsAccording to the DaptoDP protocol (Clinical Trial No. 2012-005699-33), IP DAP was administered daily, i.e., during the 6-h Nutrineal (Baxter Healthcare Corporation, Deerfield, IL, USA) dwell time period, for 14 days, in addition to administration of the antibiotics used for the usual care of patients with PDRP. The plasma and IP levels of DAP were measured on days 1 and 5. The tested dose was 200 mg/day. The principal endpoint was the dialysate concentration after 6 hours of dwell time > 16 mg/L (corresponding to 4 x minimum inhibitory concentration [MIC] for E. faecalis).ResultsThree participants were evaluated. On day 5, the IP concentrations after 6 hours of dwell time were between 6.3 and 23.4 mg/L, and the peak plasma concentrations were between 13.0 and 15.3 mg/L.ConclusionThe results suggest that 200 mg/day is very likely sufficient for the treatment of PDRP by Staphylococci or Streptococci whereas it could be insufficient to treat PRDP by Enterococci. The good peritoneal bioavailability of DAP was quantitatively established, suggesting that IP administration could also be used as an alternate route for patients with damaged venous access. No DAP accumulation that could lead to toxic concentrations after repeated administration is expected, even in anuric patients. The protocol will further continue to assess whether a higher dose achieves the pharmacokinetic objectives.