ARGIPRESSIN for Disseminated cancer

Inclusion criteria

• {"criterion_text":"- patients scheduled to undergo CRS-HIPEC"}

Exclusion criteria

• {"criterion_text":"- Known underlying heart disease [New York Heart Association (NYHA) class III or IV and/or \tknown left ventricular ejection fraction (LVEF) < 40%];"}
• {"criterion_text":"- Known unstable coronary artery disease;"}
• {"criterion_text":"- Stroke, head injury or carotid stenosis;"}
• {"criterion_text":"- Terminal kidney failure (preoperative estimated glomerular filtration rate <15 mL/min);"}
• {"criterion_text":"- Patients in whom POCUS is not possible or assessment of fluid status is unreliable e.g. BMI> 40, pulmonary fibrosis"}

Primary endpoints

• {"endpoint_text":"- \tCumulative total intraoperative fluid (mL) administration at the end of the operation, including the amounts of crystalloids and blood products","definition_or_measurement_approach":"Cumulative total intraoperative fluid (mL) at the end of operation, including amounts of crystalloids and blood products (measured as total intraoperative fluid volume in mL)."}

Secondary endpoints

• {"endpoint_text":"- \tCumulative total intraoperative fluid (mL/kg/h)","definition_or_measurement_approach":"Total intraoperative fluid normalized per kg per hour (mL/kg/h)."}
• {"endpoint_text":"- \tPostoperative fluid balance (mL)","definition_or_measurement_approach":"Postoperative fluid balance measured in millilitres (mL)."}
• {"endpoint_text":"- \tFluid balance at day 1 (mL)","definition_or_measurement_approach":"Fluid balance on postoperative day 1 measured in millilitres (mL)."}
• {"endpoint_text":"- \tSigns of fluid overload, assessed by Point-of-care ultrasound (POCUS, Appendix II) at day 0, 1 and 3.","definition_or_measurement_approach":"Signs of fluid overload assessed by POCUS on postoperative days 0, 1 and 3 as per Appendix II."}
• {"endpoint_text":"- \tMajor complications as rated as Clavien Dindo score ≥2 up to postoperative day 30","definition_or_measurement_approach":"Major complications defined as Clavien Dindo score ≥2 assessed up to postoperative day 30."}
• {"endpoint_text":"- \tAbdominal complications up to day 30","definition_or_measurement_approach":"Abdominal complications recorded up to postoperative day 30."}
• {"endpoint_text":"- \tPulmonary complications up to day 5","definition_or_measurement_approach":"Pulmonary complications recorded up to postoperative day 5."}
• {"endpoint_text":"- \tPostoperative acute kidney injury as defined by the Kidney Disease Improving Global Outcomes definition (KDIGO) up to day 5","definition_or_measurement_approach":"Postoperative acute kidney injury defined by KDIGO criteria, assessed up to day 5."}
• {"endpoint_text":"- \tQuality of recovery (QoR-15) at day 3","definition_or_measurement_approach":"Quality of recovery measured by QoR-15 questionnaire on postoperative day 3."}
• {"endpoint_text":"- \tHospital and ICU length of stay","definition_or_measurement_approach":"Length of stay in hospital and in ICU measured in days."}
• {"endpoint_text":"- \t30-day mortality","definition_or_measurement_approach":"All-cause mortality within 30 days postoperatively."}

Netherlands

Earliest CTIS Part Ii Submission Date

24-09-2024

Latest Decision Or Authorization Date

03-11-2025

Processing Time Days

405

Number Of Sites

2

Number Of Participants

70

Primary sponsor

Full Name

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands