Protocol for a hybrid effectiveness-implementation clinical trial evaluating video-assisted electronic consent vs standard consent for patients initiating and continuing haemodialysis in Australia (eConsent HD).

INTRODUCTION: Communicating complex information about haemodialysis (HD) and ensuring it is well understood remains a challenge for clinicians. Informed consent is a high-impact checkpoint in augmenting patients' decision awareness and engagement prior to HD. The aims of this study are to (1) develop a digital information interface to better equip patients in the decision-making process to undergo HD; (2) evaluate the effectiveness of the co-designed digital information interface to improve patient outcomes; and (3) evaluate an implementation strategy. METHODS AND ANALYSIS: First, a co-design process involving consumers and clinicians to develop audio-visual content for an innovative digital platform. Next a two-armed, open-label, multicentre, randomised controlled trial will compare the digital interface to the current informed consent practice among adult HD patients (n=244). Participants will be randomly assigned to either the intervention or control group. Intervention group: Participants will be coached to an online platform that delivers a simple-to-understand animation and knowledge test questions prior to signing an electronic consent form. CONTROL GROUP: Participants will be consented conventionally by a clinician and sign a paper consent form. Primary outcome is decision regret, with secondary outcomes including patient-reported experience, comprehension, anxiety, satisfaction, adherence to renal care, dialysis withdrawal, consent time and qualitative feedback. Implementation of eConsent for HD will be evaluated concurrently using the Consolidation Framework for Implementation Research (CFIR) methodology. ANALYSIS: For the randomised controlled trial, data will be analysed using intention-to-treat statistical methods. Descriptive statistics and CFIR-based analyses will inform implementation evaluation. ETHICS AND DISSEMINATION: Human Research Ethics approval has been secured (Metro North Health Human Research Ethics Committee B, HREC/2022/MNHB/86890), and Dissemination will occur through partnerships with stakeholder and consumer groups, scientific meetings, publications and social media releases. TRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trials Registry (ACTRN12622001354774).

Peritoneal dialysis-related peritonitis as a risk factor for cardiovascular events.

BACKGROUND: Cardiovascular disease is the leading cause of mortality in peritoneal dialysis (PD) patients. Infection is known to increase the risk of cardiovascular events (CVE); however, no studies have examined the association between PD peritonitis and CVE. AIM: To examine peritonitis as a risk factor for CVE in PD patients. METHODS: This retrospective cohort study included all adults undertaking PD for ≥3 months in one Australian health district from 2001 to 2015. Baseline characteristics and peritonitis event information was obtained from the Australian and New Zealand Dialysis and Transplant registry. The Centre for Health Research Illawarra Shoalhaven Population facilitated data linkage using ICD10 coding to capture CVE information. RESULTS: A total of 211 patients was included, with median age of 66 years (interquartile range 54.49-74.45); 64% were male. Peritonitis occurred in 114 (54%) patients and 65 (30.8%) patients experienced a CVE. Identified risk factors for CVE included: cerebrovascular disease (hazard ratio (HR) 2.72, 95% confidence interval (CI) 1.36-5.47), diabetes (HR 2.41, 95% CI 1.47-3.96), coronary artery disease (HR 1.67, 95% CI 1.01-2.77) and age (HR 1.03, 95% CI 1.01-1.06). There was no significant increase in risk of CVE following peritonitis (HR 1.37, 95% CI 0.81-2.32, P = 0.24), even when accounting for age, cerebrovascular disease, diabetes and existing coronary artery disease (HR 1.32, 95% CI 0.78-2.23, P = 0.30). CONCLUSIONS: We did not find an increase in the risk of CVE following a peritonitis episode in PD patients. This result may be due to small sample size or rapid peritonitis treatment mitigating cardiovascular risk.

Oxidative stress and inflammasome activation in human rhabdomyolysis-induced acute kidney injury.

Acute kidney injury (AKI) is a life-threatening complication of rhabdomyolysis. The pathophysiological mechanisms of rhabdomyolysis-induced AKI (RIAKI) have been extensively studied in the murine system, yet clinical translation of this knowledge to humans is lacking. In this study, we investigated the cellular and molecular pathways of human RIAKI. Renal biopsy tissue from a RIAKI patient was examined by quantitative immunohistochemistry (Q-IHC) and compared to healthy kidney cortical tissue. We identified myoglobin casts and uric acid localised to sites of histological tubular injury, consistent with the diagnosis of RIAKI. These pathological features were associated with tubular oxidative stress (4-hydroxynonenal staining), regulated necrosis/necroptosis (phosphorylated mixed-lineage kinase domain-like protein staining) and inflammation (tumour necrosis factor (TNF)-α staining). Expression of these markers was significantly elevated in the RIAKI tissue compared to the healthy control. A tubulointerstitial inflammatory infiltrate accumulated adjacent to these sites of RIAKI oxidative injury, consisting of macrophages (CD68), dendritic cells (CD1c) and T lymphocytes (CD3). Foci of inflammasome activation were co-localised with these immune cell infiltrate, with significantly increased staining for adaptor protein ASC (apoptosis-associated speck-like protein containing a caspase activation and recruitment domain) and active caspase-1 in the RIAKI tissue compared to the healthy control. Our clinical findings identify multiple pathophysiological pathways previously only reported in murine RIAKI, providing first evidence in humans linking deposition of myoglobin and presence of uric acid to tubular oxidative stress/necroptosis, inflammasome activation and necroinflammation.

Chronic methyl bromide toxicity is ameliorated by haemodialysis.

Methyl bromide is an odourless, colourless, highly volatile gas, primarily used in fumigation. It can cause significant neurotoxicity, especially with chronic exposure. Haemodialysis has been used in acute toxicity, but its utility in chronic exposure has never been reported. We report the use of haemodialysis in a 20-year-old man with chronic methyl bromide toxicity affecting the optic nerves, brain and spinal cord. The patient underwent eight haemodialysis sessions with improvement in plasma bromine concentration, half-life and marked clinical recovery. The case demonstrates the utility of haemodialysis in the treatment of chronic methyl bromide toxicity.

Subspecialty approach for the management of acute cholecystitis: an alternative to acute surgical unit model of care.

BACKGROUND: Acute cholecystitis is a common condition. Recent studies have shown an association between creation of an acute surgical unit (ASU) and improved outcomes. This study aimed to evaluate the outcomes of a subspecialty based approach to the management of acute cholecystitis as an alternative to the traditional 'generalist' general surgery approach or the ASU model. METHOD: A 6-year retrospective analysis of outcomes in patients admitted under a dedicated upper gastrointestinal service for acute cholecystitis undergoing emergency laparoscopic cholecystectomy. RESULTS: Seven hundred emergency laparoscopic cholecystectomies were performed over this time. A total of 486 patients were available for analysis. The median time to operation was 2 days and median length of operation was 80 min. A total of 86.9% were performed during daylight hours. Eight cases were converted to open surgery (1.6%). Intra-operative cholangiography was performed in 408 patients. The major complication rate was 8.2%, including retained common bile duct stones (2.3%), sepsis (0.2%), post-operative bleeding (0.4%), readmission (0.6%), bile leak (2.1%), AMI (0.4%), unscheduled return to theatre (0.6%) and pneumonia (0.8%). There were no mortalities and no common bile duct injuries. CONCLUSION: Over a time period that encompasses the current publications on the ASU model, a subspecialty model of care has shown consistent results that exceed established benchmarks. Subspecialty management of complex elective pathologies has become the norm in general surgery and this study generates the hypothesis that subspecialty management of patients with complex emergency pathologies should be considered a valid alternative to ASU. Access block to emergency theatres delays treatment and prolongs hospital stay.

Diabetic ketoacidosis and severe hypertriglyceridaemia as a consequence of an atypical antipsychotic agent.

The atypical antipsychotic agent clozapine, although an effective treatment for schizophrenia, is linked with metabolic adverse effects. We report a case of diabetic ketoacidosis and very severe hypertriglyceridaemia associated with clozapine use, in a patient with type 2 diabetes mellitus, who was successfully treated with continuous insulin infusion and fluids. As clozapine proved to be the most efficacious in controlling the patient's psychotic symptoms, the patient has been continued on clozapine despite its known metabolic side effects. Importantly the patient has achieved satisfactory long-term lipid and glycaemic control. The current recommendations related to the metabolic care for patients treated with atypical antipsychotic agents as well as the mechanisms behind abnormal glucose and lipid regulation with clozapine therapy are discussed.

Laparoscopic Totally Extraperitoneal Groin Hernia Repair Using a Self-Gripping Mesh: Clinical Results of 235 Primary and Recurrent Groin Hernias.

INTRODUCTION: Compared with open surgery, laparoscopic groin hernia repair has been shown to significantly reduce postoperative pain. However, chronic pain remains a problem with the laparoscopic approach, affecting approximately 10% of patients. The purpose of this study was to evaluate clinical outcomes following the use of Parietex ProGrip™ (Covidien, Dublin, Ireland) self-gripping mesh during laparoscopic totally extraperitoneal groin hernia repair. MATERIALS AND METHODS: Data were collected prospectively from 145 male and 15 female patients with 235 inguinal hernias. All patients underwent repair by the laparoscopic totally extraperitoneal approach using Parietex ProGrip mesh. During follow-up ranging from 5 to 24 months, complications, pain score, patient satisfaction, and recurrence were analyzed. RESULTS: All patients were discharged on the day of surgery or the next morning. There were no immediate complications or returns to the operating room. Delayed postoperative complications included minor bruising to the genital region (3 cases), hematoma/seroma (1 case), and wound infection (1 case). The mean follow-up was 15 months, at which time there were no reports of hernia recurrence and 99% of patients were satisfied with their hernia repair. One patient (0.63%) reported severe pain (numeric rating scale score of >7), and 4 patients (2.5%) reported intermittent mild pain on exertion. CONCLUSIONS: The results of this study suggest that the use of a self-gripping mesh during the laparoscopic totally extraperitoneal approach is a promising and effective technique for repairing both primary and recurrent inguinal hernias.