Association between the TyG index and the risk of in-hospital mortality from early sepsis-related acute kidney injury in critically ill patients: a secondary analysis of MIMIC-IV 2008-2022

Objectives
This study aims to investigate the relationship between the triglyceride-glucose (TyG) index in patients with early sepsis-associated acute kidney injury (SA-AKI) and the risk of in-hospital mortality.

Design
Secondary data analysis.

Setting
This study analysed secondary data from the Medical Information Mart for Intensive Care (MIMIC) 2008–2022.

Participants
A total of 1632 participants were enrolled in the final analysis.

Primary and secondary outcome measures
A secondary data analysis study was conducted using data from the MIMIC IV 3.0 database. Participants were divided into four groups based on the quartiles of the TyG index. The primary outcome was all-cause in-hospital mortality. The association between the TyG index and in-hospital mortality among SA-AKI patients was assessed using multivariate COX proportional hazards regression analysis and restricted cubic spline regression analysis. Subgroup and sensitivity analyses were performed to verify the robustness of results.

Results
A total of 1632 patients were included in the study. The in-hospital mortality rate was 31.13%, and the intensive care unit (ICU) mortality rate was 25.25%. Multivariate COX regression analysis showed that the TyG index was independently associated with an increased risk of in-hospital mortality (HR 1.14 (95% CI 1.02 to 1.27); p=0.02) and ICU mortality (HR 1.17; (95% CI 1.04 to 1.32); p=0.01). The restricted cubic spline regression model indicated that the risk of in-hospital and ICU mortality increased linearly with the increase in the TyG index. Sensitivity analysis demonstrated that the effect size and direction were consistent across different subgroups, and the results were stable.

Conclusion
A high TyG index is associated with increased mortality during hospitalisation in patients with SA-AKI. Larger-scale prospective studies are needed to confirm these findings.

Leggi
Maggio 2025

Effects of an extended therapeutic strategy versus standard-of-care therapy on persistent acute kidney injury in high-risk patients after major surgery: study protocol for the randomised controlled single-centre PrevProgAKI trial

Introduction
Persistent acute kidney injury (AKI) is associated with an increased morbidity and mortality. In patients with an already established AKI, the new urinary biomarker C-C motif chemokine ligand 14 (CCL14) can predict a persistent AKI. However, it is still unknown whether the implementation of nephroprotective measures in patients with an already established moderate/severe AKI can positively influence the trajectory of AKI and patients’ outcome.

Methods and analysis
The PrevProgAKI trial is a randomised, controlled, single-centre trial designed to evaluate the effectiveness of nephroprotective measures in patients with established moderate/severe AKI. We aim to enrol 480 patients with moderate or severe AKI (Kidney Disease: Imroving Global Outcomes, KDIGO, stage 2 or 3) within 72 hours of major surgery. Eligible patients will be randomised to receive either standard of care (control group) or an extended therapeutic strategy that consists of different supportive measures (intervention group). The randomisation will be stratified by urinary CCL14 results (CCL14

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Maggio 2025

Correlation between economic status and severity of type 2 diabetes mellitus in Indonesia: analysis of claim data from the national health insurance scheme, 2018-2022

Objectives
This study investigated the correlation between the type of health insurance membership as a proxy for the economic status of patients and the severity of their type two diabetes mellitus (T2DM) in Indonesia.

Design
The study conducted a secondary analysis of National Health Insurance (Jaminan Kesehatan Nasional) claim data provided by the Indonesian Social Security Agency, Badan Penyelenggara Jaminan Sosial (BPJS). We used ordered logistic regression with four severity levels for T2DM (0=outpatient, I=mild, II=moderate, III=severe) as dependent variables. The main independent variables (insurance membership categories) included subsidised insurance members (PBI), a combination of formally employed and nonsalaried informal workers (PBPU & PPU) and nonworkers (BP).

Setting
Secondary healthcare facilities in Indonesia.

Participants
The dataset included 2 989 618 claims for hospital visits of people with T2DM from 2018 to 2022.

Primary outcome measures
Severity level of T2DM patients.

Result
A higher percentage of T2DM patients who visited healthcare facilities with subsidised insurance (PBI), which represents a low-income group, have severe disease (6.9%) than patients in the PBPU & PPU (4.9%) and BP categories (5.5%). Moreover, regression analysis revealed that having PBI membership status was associated with a greater OR of having severe T2DM than nonsubsidised members. Among T2DM patients in the nonsubsidised insurance category, workers (PBPU & PPU) had an OR of 0.74 (95% CI: 0.735 to 0.745; p

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Maggio 2025

TELEnutrition and KIdNey hEalth Study: protocol for a randomised controlled trial comparing the effect of digital health to standard care on serum phoSphate control in patients on dIalysiS (TeleKinesis Study)

Introduction
Diet and nutrition play a vital role in all stages of chronic kidney disease (CKD) prevention, treatment and management. In particular, dietary interventions are essential to manage hyperphosphataemia, a common metabolic complication in CKD consistently associated with an increased risk of cardiovascular disease and all-cause morbidity and mortality. Unfortunately, dietary management of any kind in this cohort of patients also comes with the added challenge of limited and variable access to renal dietitians, logistical difficulties and multiple medical appointments. Given the complexity of managing diet in patients on dialysis, there is a need for novel interventions that not only help patients navigate daily challenges but could also be integrated into clinical practice to support the work of dietitians. We are testing if the use of digital health (via a new, specifically designed smartphone App) plus standard care compared to standard care alone is a feasible and effective method of delivering nutritional advice to patients with elevated phosphate levels undertaking dialysis.

Methods and analysis
This is a multicentre codesigned randomised controlled trial (RCT) that will recruit individuals aged 18 years or over on maintenance dialysis for a minimum of 3 months who have a serum phosphate level of ≥1.6 mmol/L. Participants will be recruited from 23 different dialysis sites across Australia. They will be block randomised into two groups in a 1:1 ratio that will either be the intervention group (receive the TeleKinesis App for 3 months in addition to standard care) or the control group (standard care alone). The primary outcome of the study is to assess the effect of this intervention on the change in patients’ serum phosphate levels. The RCT will assess the effectiveness of the programme by comparing serum phosphate at baseline, 3 months and follow-up at 6 months. A total recruitment target of n=180 participants is expected.

Ethics and dissemination
Ethics approval was received from the Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee on 5 December 2022 (reference RGS0000005559). Informed consent will be given by participants once they have read and signed the patient information and consent form. The results are expected to be published in scientific journals and presented at clinical research conferences and to the consumers who have taken part in the trial. This is protocol 1.0 dated 10 November 2024.

Trial registration number
ACTRN12621000746831.

Leggi
Maggio 2025

Awake Prone Positioning in COVID-19—Is There a New Standard of Care?

In this issue of JAMA Internal Medicine, Luo et al presented compelling evidence for awake prone positioning for patients with acute hypoxemic respiratory failure from COVID-19. Their meta-analysis based on individual patient data from 3019 patients in 14 randomized clinical trials demonstrated that awake prone positioning significantly improved survival without intubation and reduced both the risk of intubation and hospital mortality. The improved survival was most pronounced in individuals who had moderate to severe hypoxemia (pulse saturation to inhaled oxygen fraction ratio between 155 and 232), were younger than 68 years, had a body mass index between 26 and 30 (calculated as weight in kilograms divided by height in meters squared), and had prone positioning initiated within 1 day of hospitalization. Notably, patients who maintained prone positioning for at least 8.3 hours daily during the first 3 days of hospitalization had better outcomes than those with shorter prone times. This rigorous meta-analysis provides important evidence for managing critically ill patients with acute hypoxemic respiratory failure.

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Maggio 2025

Is ambulance conveyance associated with distance to hospital and patient outcomes? A register-based cohort study in Region Zealand, Denmark, 2017-2022

Background
Non-conveyance, the decision not to transport a patient to a healthcare facility, can result from patient refusal or the ambulance professional’s decision. Distance to hospital may influence decisions on non-conveyance, which offers benefits such as reduced pressure on emergency departments, quicker ambulance availability and potentially better patient comfort.

Objectives
The aim of this study was threefold: (1) to determine the proportion of patients attended by an ambulance and not subsequently transported to a hospital (non-conveyance), (2) to study whether distance to hospital is associated with non-conveyance, and (3) to examine the association between non-conveyance and subsequent contact to the healthcare system and mortality within both 48 hours and 30 days from the primary contact.

Design, setting and participants
A register-based cohort study of emergency ambulance dispatches (priority A or B) from October 2017 to December 2022 in Region Zealand, Denmark. Data were linked to national registries using patients’ personal identification numbers.

Outcome measures and analysis
The proportion of non-conveyed patients was calculated. The association between distance to allocated hospital and non-conveyance and the association between non-conveyance and subsequent contact with the healthcare system and mortality were analysed using logistic regression analyses.

Results
A total of 383 611 ambulance dispatches were included. Overall, 16.6% (95% CI: 16.4; 16.6) of the patients were non-conveyed during the study period. The annual proportion increased from 12.3% (95% CI: 11.7; 12.9) in 2017 to 19.8% (95% CI: 19.6; 20.1) in 2022. A longer distance to the allocated hospital was associated with higher odds for non-conveyance. Odds for non-conveyance were 1.82 (95% CI: 1.76; 1.88) times higher for distances 40–50 km compared with distances 0–10 km. A higher odds of subsequently contacting the healthcare system was found for non-conveyed patients, while there were lower odds for mortality.

Conclusion
The proportion of non-conveyed patients increased from 2017 to 2022. Non-conveyance increased with an increasing distance to the allocated hospital (p for trend

Leggi
Aprile 2025

Genomic testing for bleeding disorders (GT4BD): protocol for a randomised controlled trial evaluating the introduction of whole genome sequencing early in the diagnostic pathway for patients with inherited bleeding disorders as compared with standard of care

Introduction
The current diagnostic pathway for patients with a suspected inherited bleeding disorder is long, costly, resource intensive, emotionally draining for patients and often futile, as half of patients will remain without a diagnosis and be labelled ‘bleeding disorder of unknown cause’. Advances in understanding the genetic basis of the inherited bleeding disorders, coupled with both increasing infrastructure for genetic/genomic testing and decreasing costs, have increased the feasibility of introducing genomic testing into the clinical diagnostic pathway as a potential solution to improve the care of these patients. Yet, there remain evidence gaps on the optimal integration of genomic analysis into the diagnostic pathway.

Methods and analysis
Using a multicentre randomised-controlled trial design, we will evaluate an early genomic testing strategy for the diagnosis of newly referred patients with a suspected inherited bleeding disorder. Eligible participants will be randomised to early genomic testing diagnostic pathway (intervention) or standard diagnostic pathway (control) and will be followed for a 12-month period. Patients in the control group who remain undiagnosed at study end will be offered identical early genomic testing to ensure equitable access to the intervention. The study will follow a parallel fixed design with waitlist control group and a 1:1 allocation ratio. The study will be conducted at three tertiary care centres in Ontario, Canada, with a target sample size of 212 participants. Clinical utility will be evaluated via the primary outcome of diagnostic yield, as well as the secondary outcome of time to diagnosis. Additional secondary outcomes will allow for assessment of patient impact via health-related quality of life and patient burden measures, as well as evaluation of economic impact through a cost-effectiveness analysis and budget impact analysis.

Ethics and dissemination
This investigator-initiated study was approved by the Queen’s University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board through Clinical Trials Ontario (CTO-4909). Participant informed consent/assent is required. Findings will be disseminated through academic publications.

Trial registration number
ClinicalTrials.gov, NCT06736158.

Leggi
Aprile 2025