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ALBU-CHIP - Efficacy of human 20% albumin solution + Ringer Lactate versus Ringer Lactate for fluid replacement strategy during cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy : a randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510943-76-00
Acronym
APHP230864
Enrollment
140
Registered
2025-03-20
Start date
2025-09-03
Completion date
Unknown
Last updated
2025-08-27

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

Conditions

Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy

Brief summary

Comprehensive Complication Index (CCI score) at day 28

Detailed description

CCI score at day 7, volume of intra operative and post-operative (48h) post-operative fluid therapy, cumulated incidence of surgical post-operative complications at 28 days, cumulated incidence of infectious post-operative complications at 28 days, cumulated incidence of medical post-operative complications at 28 days, need for mechanical ventilation, renal replacement therapy between surgery and day 28, SOFA score variation between pre-operative period and 48h after surgery, number of days alive out of intensive care unit and out of hospital until day 28, mortality at day 28, Hypersensitivity reactions to albumin at 133 days

Interventions

DRUGVIALEBEX 200 g/L
DRUGsolution pour perfusion

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Comprehensive Complication Index (CCI score) at day 28

Secondary

MeasureTime frame
CCI score at day 7, volume of intra operative and post-operative (48h) post-operative fluid therapy, cumulated incidence of surgical post-operative complications at 28 days, cumulated incidence of infectious post-operative complications at 28 days, cumulated incidence of medical post-operative complications at 28 days, need for mechanical ventilation, renal replacement therapy between surgery and day 28, SOFA score variation between pre-operative period and 48h after surgery, number of days alive out of intensive care unit and out of hospital until day 28, mortality at day 28, Hypersensitivity reactions to albumin at 133 days

Countries

France

Outcome results

None listed

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