Epidural analgesia-related maternal fever (ERMF) affects 15%–25% of parturients, posing risks to both maternal and neonatal. Although ERMF’s mechanisms remain unclear, non-infectious inflammatory responses and thermoregulatory disruption are implicated. Previous studies suggest that room-temperature local anaesthetic solutions administered during epidural analgesia may contribute to ERMF by altering spinal thermoregulation. This trial investigates whether warming local anaesthetic solutions to body temperature reduces ERMF incidence.

This two-centre, double-blind, randomised controlled trial will enrol 424 parturients undergoing epidural analgesia for trial of labour. Participants will be randomised (1:1) to receive either body temperature (approximately 37°C) or room temperature (approximately 23°C) local anaesthetic solutions (0.1% ropivacaine with 0.5 µg/mL sufentanil). The primary outcome is intrapartum fever incidence, defined as oral temperature ≥38°C. Secondary outcomes include time to visual analogue scale ≤3, pulse perfusion index, maternal and neonatal antibiotic use rate, incidence of bacteraemia, intrapartum hypothermia, duration of labour, unplanned caesarean section rate, umbilical artery potential of hydrogen and Apgar scores at 1 and 5 min for newborns. Randomisation, stratified by study centre, employs permuted blocks via R software. Blinding is maintained for participants, outcome assessors and statisticians. A sample size of 424 participants (212 per group) provides 80% power (α=0.05) to detect a reduction in fever incidence from 21% to 10%. The primary analysis will be conducted in accordance with the intention-to-treat principle, with a secondary per-protocol analysis.

The study protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Soochow University (Approval No. 2023367-2) and the Ethics Committee of Suzhou Municipal Hospital (Approval No. K-2024-258 K01), and adheres to the Declaration of Helsinki. All participants will provide written informed consent. Results will be disseminated through peer-reviewed journals.

NCT06682416.

Prognosis estimation is the basis for establishing the personal interventions in sepsis patients. Serum biomarkers are potential tools for predicting the outcomes of sepsis patients admitted to the intensive care unit (ICU). Here, we plan to perform a prospective study to investigate the prognostic value of serum biomarkers. We named this study Hospital Outcome of Host Heterogeneity, Organ dysfunction and Trajectory in sepsis (HOHHOT).

This prospective cohort study is being performed in several hospitals in the Inner Mongolia Autonomous Region between 2025 and 2027. The inclusion criteria were adult sepsis patients admitted to the ICU. A serum specimen will be collected at the onset of sepsis and stored at –80°C for future use. The endpoint of the HOHHOT study includes, but is not limited to, hospital outcome (eg, mortality, occurrence of organ dysfunction, treatment response and the progression of sepsis). We will analyse the predictive value of serum biomarkers for outcomes using a receiver operating characteristic curve and decision curve analysis. The association between baseline characteristics and serum biomarkers will be estimated using a logistic regression model, net reclassification index and integrated discriminatory index. We will also construct some predictive models using machine learning algorithms.

The HOHHOT study has been approved by the Ethics Committee of the Affiliated Hospital of Inner Mongolia Medical University (NO: KY2025005). The findings derived from the HOHHOT study will be submitted to international academic journals.

Chinese Clinical Trial Registry (ChiCTR2500100770); pre-results.