Postictal agitation (PIA) is a common adverse effect following electroconvulsive therapy (ECT). Current pharmacological treatments for PIA have undesirable side effects, and interventions to prevent PIA are unsatisfactory. The aim of this study is to assess the effect of peri-interventional music on PIA for patients undergoing ECT. Additionally, the study will assess the impact of music on pretreatment anxiety and post-treatment cognitive impairment.

This multicentre, open-label, parallel randomised controlled trial (RCT) aims to include 92 patients from two centres in Rotterdam, the Netherlands. Participants will be randomised into two groups: a music intervention group and a control group. The music group listens to recorded music 30 min before and 12 min after each of the first six ECT sessions of the full ECT course, while the control group will receive standard care. The primary outcome is the presence of PIA, measured using the Richmond Agitation-Sedation Scale (RASS). Secondary outcomes include the severity and duration of PIA, pretreatment anxiety, recovery duration, peri-treatment medication requirements, cognitive impairment and depression severity. Data will be analysed according to an intention-to-treat principle.

This study protocol has been approved by the Medical Ethical Review Committee of the Erasmus Medical Centre on 28 January 2025 (MEC-2024–0467) and subsequently received local approval at Antes Parnassia group. The trial will be carried out following the Declaration of Helsinki principles. Study results will be reported in a peer-reviewed journal according to the Consolidated Standards of Reporting Trials guidelines.

NCT06817330.

Neutropenic fever (NF) has a crude mortality rate of 3–18%. International guidelines recommend that all patients with NF receive ultrabroad-spectrum antibiotics (UBSAs) within 1 hour of emergency department (ED) registration. However, over 70% patients presenting to hospital with suspected NF (sNF) cannot access absolute neutrophil count (ANC) result within 1 hour, do not have NF and do not require UBSAs. In ED and hospitalised patients with sNF, we hypothesise that the ASTERIC protocol effectively and safely reduces the use of UBSAs compared with standard care alone.

This pragmatic, parallel, multicentre, type 1, hybrid effectiveness-implementation, stepped-wedge, before-and-after, cluster randomised controlled trial aims to evaluate whether antibiotic prescribing can be safely reduced through implementing a multifaceted antibiotic stewardship intervention (ASTERIC) in adult patients with sNF presenting to EDs. The sNF was defined as a fever with a single oral temperature of ≥38.3°C (101°F) within 24 hours before ED registration or a temperature of ≥38.0°C (100.4°F) sustained over a 1-hour period, following last chemotherapy or targeted therapy within 6 weeks for any solid tumour, or in any period following therapies against leucaemia, lymphoma, myelodysplastic syndrome, aplastic anaemia, multiple myeloma or recipient of HSCT. The study will involve eight hospitals in Hong Kong with variable baseline practice. We will include 704 adult patients (352 patients in pre-implementation and post-implementation periods, respectively) with sNF (tympanic temperature ≥38.3°C) and 48 staff participants (6 staff participants in each hospital). Healthcare professionals will receive a multifaceted stewardship intervention consisting of risk assessment tools, fast-track ANCs, a decision tool for patient management and antibiotic use, supported by an educational package and staff interaction programmes (ASTERIC protocol). Patients’ blood ANC, and cancer therapy and chronic illness therapy scores will be measured. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) and Proctor conceptual frameworks will be followed for evaluation of implementation. The main outcome measures are the mean total dose of UBSAs prescribed in 7 days and serious adverse events at 30 days. Data analysis will incorporate intention-to-treat, per-protocol and as-treated analyses for service outcomes (effectiveness, safety, quality of life assessments and cost-effectiveness) and mixed methods for implementation outcomes, informed by the Theoretical Domains Framework. We expect that the study results will inform health policy with improvement in hospital services in treating stable sNF, evidenced by improved safe antibiotic stewardship, early antibiotic de-escalation and reduced costs and length of stay.

The institutional review boards of all study sites approved this study. This study will establish the ASTERIC protocol safely improves antibiotic stewardship and clinical management in adult patients with sNF. We will disseminate the findings through peer-reviewed publications, conference presentations and educational activities. All patients with sNF will be influenced by the new protocol which is agreed at hospital level. Randomisation is at hospital level, not patient level. Patient consent is sought for follow-up and data access, not for treatment. Staff consent is sought for interviewing.

NCT06794320.

To evaluate the long-term efficacy of remote ischaemic postconditioning (RIPC) on functional outcomes in patients with acute ischaemic stroke (AIS) who received intravenous thrombolysis (IVT).

This was a post-trial follow-up study of a rater-blinded randomised controlled trial.

Single-centre study conducted in a tertiary hospital in China, with follow-up interviews performed via telephone approximately 4.8 years after randomisation (November 2022).

The original trial (NCT03218293) included 68 patients allocated either to the control group (n=34) or the RIPC group (n=32) between August 2017 and June 2018. For this follow-up, 62 patients (93.9%) were successfully contacted and included in the analysis.

The primary outcome was the proportion of patients achieving a favourable functional outcome, defined as a modified Ranking Score (mRS) 0 or 1 at long-term follow-up. Secondary outcomes included functional independence (mRS 0–2), recurrent stroke/transient ischaemic attack (TIA) and all-cause mortality. Binary outcomes were analysed using generalised linear models with inverse probability of treatment weighting (IPTW) adjustment. Time-to-event analyses employed IPTW-weighted Kaplan-Meier curves and Cox proportional hazards models, with statistical significance set at p

At a median follow-up of 4.8 years (IQR 4.6–5.1), the proportion of favourable functional outcome was higher in the RIPC group when compared with the control group (unadjusted risk ratio, 3.87; 95% CI 1.34 to 11.17; p=0.012 and IPTW-adjusted risk ratio, 5.92; 95% CI 1.45 to 24.24; p=0.017). The RIPC group also showed a trend towards improved stroke/TIA recurrence-free survival compared with the control group (IPTW-adjusted HR, 0.52; 95% CI 0.06 to 1.00; p=0.050).

IVT combined with repeated in-hospital RIPC may lead to improved long-term functional recovery and reduced stroke/TIA recurrence in patients with AIS. Larger multicentre trials are warranted to confirm these findings.

NCT05614401.