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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Neoplasms [C04]

Trial duration

3 Sep 2025 → ongoing

Decision date (initial)

2025-03-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To assess the efficacy of 20% albumin combined with Ringer Lactate versus Ringer Lactate for fluid therapy during CRS with HIPEC on post operative outcome at 28 day.

Secondary objectives 1

1. To evaluate the impact of fluid therapy with 20% albumin combined with Ringer Lactate versus Ringer Lactate alone in patients undergoing cytoreduction surgery with HIPEC for peritoneal carcinosis.

Conditions and MedDRA coding

Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 18 years old and older
2. Planned cytoreductive surgery with HIPEC for peritoneal carcinomatosis (from gynaecological or digestive origin)
3. Patient volunteer for the study and provided written informed consent
4. Patient affiliated to the French Health Insurance

Exclusion criteria 19

1. Pre-operative disease influencing plasmatic albumin levels (hepatic cirrhosis, nephrotic syndrome, exudative enteropathy, severe denutrition)
2. Chronic kidney disease (estimated glomerular filtration rate < 30 mL/min/1.73m2 or need for renal replacement therapy)
3. Participation in another interventional research project or being in the exclusion period following a previous research project
4. Patient deprived of liberty
5. Patient under guardianship
6. Severe pre-operative Hypoalbuminemia (albuminemia < 20g/L)
7. Chronic heart failure with reduced ejection fraction (left ventricular ejection fraction < 40%)
8. Allergy to exogen human albumin
9. Allergy to Ringer Lactate
10. Hyperkaliemia > 6.0 mmol/L
11. Hypercalcemia > 2.60 mmol/L
12. Chronic use of digitalis and hyperkalemic diuretics
13. Pregnancy, Breast feeding
14. Aged > 75 years old
15. Functional status making the patient ineligible for cytoreduction with CHIP (ECOG > 2 or Karnofsky scale < 75)
16. Patients at high risk of intra- and post-operative pulmonary complications (atelectasis, large pleural effusions)
17. Significant ascites with preoperative respiratory impact
18. Unbalanced diabetes (HbA1c > 8.5%)
19. Recent cerebral trauma < 6 months (of traumatic, ischemic or hemorrhagic origin)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Comprehensive Complication Index (CCI score) at day 28

Secondary endpoints 11

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

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Arthur MOREAU

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Arthur MOREAU

Locations

1 EU/EEA country · 8 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 7 files

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

Application history

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