Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Apr 2, 2024
Trial Information
Current as of July 25, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial, called ALBUCHIP, is studying the effects of using a special fluid called 20% albumin combined with Ringer Lactate during a specific type of surgery known as cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC). This surgery is commonly used to treat certain cancers that have spread in the abdominal area. The researchers want to find out if using this combination of fluids can lead to better recovery outcomes for patients compared to using Ringer Lactate alone.
To participate in this trial, patients must be 18 years or older and scheduled for this type of surgery due to peritoneal cancer from either gynecological or digestive origins. They must also agree to take part in the study and sign a consent form. Throughout the trial, patients can expect to receive careful monitoring before, during, and after their surgery, with follow-up assessments to track their recovery. This study is important because it could help improve how doctors manage fluid therapy during major surgeries, potentially leading to better health outcomes for patients undergoing HIPEC.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Male and female patients aged 18 years old and older
- • Planned cytoreductive surgery with HIPEC for peritoneal carcinomatosis (from gynaecological or digestive origin)
- • Patient volunteer for the study and provided written informed consent
- • Patient affiliated to the French Health Insurance
- Exclusion Criteria:
- • Refusal to participate to the study
- • Pre operative disease influencing plasmatic albumin levels (hepatic cirrhosis, nephrotic syndrome, exudative enteropathy, severe denutrition with albuminemia \< 20g/L)
- • Chronic heart failure with reduced ejection fraction (left ventricular ejection fraction \< 40%)
- • Allergy to exogen human albumin
- • Pregnancy
- • Breast feeding
- • Chronic kidney disease (estimated glomerular filtration rate \< 30 mL/min/1.73m2 or need for renal replacement therapy)
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported