Decrease of intraoperative fluid administration in cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) with vasopressin (HiPRESS)
interventional
N/A
1 country
2
To determine if low-dose argipressin decreases cumulative intraoperative fluid administration during CRS-HIPEC surgery compared to standard noradrenaline when using a standard GDT protocol
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 16, 2024
Actual (reported)• Cumulative total intraoperative fluid (mL) administration at the end of the operation, including the amounts of crystalloids and blood products
• 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
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Formulated product
Empressine 40 I.E./2ml, concentraat voor oplossing voor infusie
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Empressine 40 I.E./2ml, concentraat voor oplossing voor infusie
Named ingredient: Argipressin
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Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Amsterdam, 1066 CX, Netherlands
Stichting Amsterdam UMC
Amsterdam, 1081 HV, Netherlands
Sabrine Hemmes
First Submitted
July 16, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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