Monitoring inflammation during cancer surgery using heart and brain signals

Perioperative systemic inflammatory response syndrome monitoring with electroencephalogram and heart rate variability

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN11473363

Enrollment

Registered

2025-07-09

Start date

2023-05-10

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients scheduled for an abdominal/gynaecological oncological surgical procedure +/- combined with hyperthermic intraperitoneal chemotherapy (HIPEC) Surgery

Interventions

Participants in this study are adult patients scheduled for abdominal or gynaecological cancer surgery, with or without heated chemotherapy (HIPEC). After giving informed consent, they will be monitor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged =18 years 2. Scheduled for an abdominal/gynaecological oncological surgical procedure +/- combined with HIPEC

Exclusion criteria

Exclusion criteria: 1. Inability to provide informed consent 2. Allergy to adhesive electrodes 3. Presence of a pacemaker/ICD 4. Recent cardiopulmonary arrest 5. Cardiac arrhythmias 6. Atrial fibrillation

Design outcomes

Primary

Measure	Time frame
Inflammation levels are measured using cytokine concentrations (e.g. IL-6, TNF-a) in blood samples taken at baseline (before surgery), and every 30 minutes during surgery (until the end of surgery). These are compared with: Heart rate variability (HRV) parameters (e.g. LF, HF, RMSSD) and EEG parameters (e.g. Spectral Edge Frequency, Burst Suppression)	—

Secondary

Measure	Time frame
1. Impact of anaesthetic type (propofol vs sevoflurane) on HRV and EEG parameters — measured during surgery using the CoreSys One device. Device usability: 2. User experience and technical performance of the CoreSys One device — assessed through qualitative feedback forms completed by clinical staff post-surgery. Clinical outcomes: 3. Organ dysfunction: Presence of acute kidney injury (AKI), postoperative delirium (POD), acute lung injury (ALI), perioperative myocardial injury (P-AMI) — extracted from medical records within 48 hours after surgery. 4. Length of ICU stay — recorded in days from medical records. 5. Length of hospital stay — recorded in days from medical records. 6. 28-day mortality — assessed through patient follow-up in hospital records. 7. Surgical complications graded using Clavien-Dindo classification (CD = 3) — assessed during hospital stay.	—

Measure

Time frame

1. Impact of anaesthetic type (propofol vs sevoflurane) on HRV and EEG parameters — measured during surgery using the CoreSys One device. Device usability: 2. User experience and technical performance of the CoreSys One device — assessed through qualitative feedback forms completed by clinical staff post-surgery. Clinical outcomes: 3. Organ dysfunction: Presence of acute kidney injury (AKI), postoperative delirium (POD), acute lung injury (ALI), perioperative myocardial injury (P-AMI) — extracted from medical records within 48 hours after surgery. 4. Length of ICU stay — recorded in days from medical records. 5. Length of hospital stay — recorded in days from medical records. 6. 28-day mortality — assessed through patient follow-up in hospital records. 7. Surgical complications graded using Clavien-Dindo classification (CD = 3) — assessed during hospital stay.

—

Countries

Netherlands

Contacts

Public ContactGertrude Nieuwenhuijs-Moeke

g.j.nieuwenhuijs-moeke@umcg.nl+31 (0)503616161

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026