Actively Recruiting
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-12-05
140
Participants Needed
7
Research Sites
N/A
Total Duration
Researchers are evaluating the use of 20% albumin combined with Ringer Lactate versus Ringer Lactate alone for fluid therapy during cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC), which is a standard treatment for peritoneal metastases. This study aims to determine whether using 20% albumin can reduce the volume of intraoperative crystalloid infusion and improve postoperative outcomes, focusing on complications within 28 days after surgery. The trial is randomized, comparative, controlled, open-label, and involves multiple centers. Participants are randomly assigned to receive either a combination of 20% albumin and Ringer Lactate or Ringer Lactate alone during surgery. The albumin group receives a bolus of 3 mL/kg over one hour starting at anesthesia induction, followed by additional 20% albumin infusions based on vascular filling volume, with albuminemia monitored to keep levels within a target range. The control group receives Ringer Lactate fluid management according to current scientific recommendations. The intervention lasts for the entire duration of the surgery. During the study, participants will be monitored for postoperative complications using the Comprehensive Complication Index at days 7 and 28, mortality at day 28, fluid volumes administered intra- and postoperatively, and other outcomes such as mechanical ventilation days, renal replacement therapy, and organ failure scores. The study includes preoperative assessment, randomization before surgery, and follow-up for 28 days after surgery to evaluate safety and effectiveness. This detailed monitoring will help understand the impact of fluid management strategies on recovery after CRS with HIPEC.
CONDITIONS
Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the surgery
Participants undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC). During surgery, participants receive fluid therapy with either 20% albumin combined with Ringer Lactate or Ringer Lactate alone, according to their assigned group.
1 intraoperative visit
Duration - Up to 133 days
Participants are monitored after surgery to assess complications, organ function, and recovery up to 28 days post-surgery, including assessments of fluid therapy effects and potential allergic reactions to albumin up to day 133.
Multiple visits up to 28 days post-surgery and additional assessments up to day 133
Total: 7 locations
1
Institut régional du Cancer de Montpellier
Montpellier, France
Actively Recruiting
2
La Pitié Salpetriere hospital
Paris, France, 75013
Actively Recruiting
3
Lariboisière hospital
Paris, France
Actively Recruiting
4
Saint Louis hospital
Paris, France
Actively Recruiting
5
Robert Debré hospital
Reims, France
Actively Recruiting
6
Hôpital Hautepierre / UIC ARMO
Strasbourg, France
Actively Recruiting
7
Gustave Roussy Institute
Villejuif, France
Actively Recruiting
A
Arthur Moreau, Dr
J
Jérôme Lambert, Pr
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Benjamin Deniau, Arthur Moreau, Antoine Monsel...
https://pubmed.ncbi.nlm.nih.gov/42044958