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Decrease of intraoperative fluid administration in cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) with vasopressin (HiPRESS)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513598-33-00
Enrollment
70
Registered
2024-11-11
Start date
2025-01-21
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

Disseminated cancer

Brief summary

• Cumulative total intraoperative fluid (mL) administration at the end of the operation, including the amounts of crystalloids and blood products

Detailed description

• Cumulative total intraoperative fluid (mL/kg/h), • Postoperative fluid balance (mL), • Fluid balance at day 1 (mL), • Signs of fluid overload, assessed by Point-of-care ultrasound (POCUS, Appendix II) at day 0, 1 and 3., • Major complications as rated as Clavien Dindo score ≥2 up to postoperative day 30, • Abdominal complications up to day 30, • Pulmonary complications up to day 5, • Postoperative acute kidney injury as defined by the Kidney Disease Improving Global Outcomes definition (KDIGO) up to day 5, • Quality of recovery (QoR-15) at day 3, • Hospital and ICU length of stay, • 30-day mortality

Interventions

DRUGEmpressine 40 I.E./2ml

Sponsors

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
• Cumulative total intraoperative fluid (mL) administration at the end of the operation, including the amounts of crystalloids and blood products

Secondary

MeasureTime frame
• Cumulative total intraoperative fluid (mL/kg/h), • Postoperative fluid balance (mL), • Fluid balance at day 1 (mL), • Signs of fluid overload, assessed by Point-of-care ultrasound (POCUS, Appendix II) at day 0, 1 and 3., • Major complications as rated as Clavien Dindo score ≥2 up to postoperative day 30, • Abdominal complications up to day 30, • Pulmonary complications up to day 5, • Postoperative acute kidney injury as defined by the Kidney Disease Improving Global Outcomes definition (KDIGO) up to day 5, • Quality of recovery (QoR-15) at day 3, • Hospital and ICU length of stay, • 30-day mortality

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026