Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy

NANot yet recruitingINTERVENTIONAL
Enrollment

146

Participants

Timeline

Start Date

September 30, 2024

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2026

Conditions
Peritoneal NeoplasmsHyperthermic Intraperitoneal ChemotherapyIntraoperative CareFluid TherapyPostoperative Complications
Interventions
OTHER

Intra-operative albumin administration

Patients randomized in the intervention group (20% albumin + Ringer Lactate) will receive, during cytoreductive surgery with HIPEC, fluid therapy consisting in Ringer Lactate (based on a fluid management protocol specifically set up for the study, and based on latest recommendations) combined with 20% albumin. Patients randomized in the intervention group will receive a bolus of 3 mL/kg on one hour of 20% albumin from anesthetic induction . Dosage of albuminemia will be done 2 hours after the end of the bolus (target of 35-45 g/L of intra operative albuminemia). Then, infusion of 20% albumin (100 mL, 20g) will be administered for each 1200 mL of vascular filling by Ringer Lactate. Dosage of intra operative albuminemia will be realized 2 hours after the end of the bolus or infusion to ensure albuminemia is within the target concentrations (35-45 g/L). Use of 20% albumin will be realized for the entire duration of the surgery and stopped at the end of the surgery.

OTHER

Control

Ringer lactate

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT06351475 - Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy | Biotech Hunter | Biotech Hunter