HiPRESS study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]

Trial duration

21 Jan 2025 → ongoing

Decision date (initial)

2024-11-11

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Therapy

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

Secondary objectives 2

1. • To determine if low-dose argipressin decreases postoperative fluid overload compared to standard noradrenaline when using a standard GDT protocol
2. • To determine if low-dose argipressin decreases postoperative complications and improves outcome and recovery compared to standard noradrenaline when using a standard GDT protocol

Conditions and MedDRA coding

Disseminated cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. patients scheduled to undergo CRS-HIPEC

Exclusion criteria 5

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 11

1. • Cumulative total intraoperative fluid (mL/kg/h)
2. • Postoperative fluid balance (mL)
3. • Fluid balance at day 1 (mL)
4. • Signs of fluid overload, assessed by Point-of-care ultrasound (POCUS, Appendix II) at day 0, 1 and 3.
5. • Major complications as rated as Clavien Dindo score ≥2 up to postoperative day 30
6. • Abdominal complications up to day 30
7. • Pulmonary complications up to day 5
8. • Postoperative acute kidney injury as defined by the Kidney Disease Improving Global Outcomes definition (KDIGO) up to day 5
9. • Quality of recovery (QoR-15) at day 3
10. • Hospital and ICU length of stay
11. • 30-day mortality

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Sponsor organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Address

Plesmanlaan 121

City

Amsterdam

Postcode

1066 CX

Country

Netherlands

Scientific contact point

Organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Contact name

Sabrine Hemmes

Public contact point

Organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Contact name

Sabrine Hemmes

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications