Efficacy of Human Albumin Solution and Ringer Lactate Versus Ringer Lactate in Fluid Management During Cytoreductive Surgery with HIPEC

The primary objective of this study is to assess the **efficacy** of 20% **albumin** combined with Ringer Lactate versus Ringer Lactate alone for fluid therapy during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) on postoperative outcomes at 28 days. This evaluation is clinically relevant as it aims to determine the optimal fluid replacement strategy to improve recovery and reduce complications in patients undergoing this complex surgical procedure for peritoneal carcinomatosis.

Secondary objectives include evaluating 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. This will provide further insights into the potential benefits of albumin in enhancing surgical outcomes and patient recovery.

The clinical trial involves a study population comprising both **male** and **female** participants aged 18 years and older. The participants are individuals scheduled for **cytoreductive surgery** with **hyperthermic intraperitoneal chemotherapy** (HIPEC) due to peritoneal carcinomatosis originating from either gynecological or digestive sources. The trial does not include a vulnerable population. Participants are required to be affiliated with the French Health Insurance and must have provided written informed consent to partake in the study. The sponsor has not provided information regarding the total number of participants. No specific lifestyle considerations such as diet or physical activity are highlighted for this trial. The selection criteria ensure that participants are volunteers who meet the age and medical condition requirements, aligning with the study's objective to evaluate the efficacy of 20% albumin combined with Ringer Lactate versus Ringer Lactate alone for fluid therapy during the surgical procedure.

The clinical trial is designed to evaluate the **efficacy** of a 20% **human albumin solution** combined with Ringer Lactate compared to Ringer Lactate alone for fluid therapy during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC). This is a randomized, controlled, double-blind trial aimed at assessing post-operative outcomes at 28 days. The trial is expected to commence on January 1, 2025, and conclude by May 15, 2027. Participants will be randomly assigned to receive either the combination therapy or the control treatment, with neither the participants nor the investigators aware of the group assignments to ensure unbiased results.

The study will involve several key visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age (18 years and older), planned surgery, and informed consent. Follow-up visits will be scheduled to monitor the participants' health status and collect data on primary and secondary endpoints, including the Comprehensive Complication Index (CCI) score at day 28, volume of fluid therapy, and incidence of post-operative complications. The end-of-study visit will occur at the 28-day mark to assess the final outcomes and any adverse events.

Participant involvement is expected to last approximately 28 days, with conditions for early termination including withdrawal of consent, significant protocol deviations, or adverse events that compromise participant safety. The trial will adhere to rigorous scientific and ethical standards to ensure the validity and reliability of the findings, contributing valuable insights into the management of fluid therapy during complex surgical procedures.

The clinical trial involves the administration of **VIALEBEX 200 g/L**, a **solution for infusion** containing **human albumin solution** as the active substance. This product is manufactured by LFB BIOMEDICAMENTS and is classified under the ATC code B05AA01, which corresponds to **albumin**. The pharmaceutical form is a solution for infusion, and it is administered via the **parenteral** route. The maximum daily dose is 240 grams, with a total maximum dose of 240 grams over a treatment period of one day. The human albumin solution is derived from blood, categorized as a structurally diverse substance. This experimental medication is used in the trial to evaluate its efficacy in fluid replacement therapy during cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS with HIPEC).

The comparator treatment in this study is **Ringer Lactate**, which is also administered parenterally. The active substance in this solution is **mannitol**, classified under the ATC code B05BB01, which pertains to **electrolytes**. The maximum daily dose for Ringer Lactate is 14.4 liters, with a total maximum dose of 14.4 liters over a one-day treatment period. Mannitol is a chemical substance, and the product is not a pediatric formulation. The trial aims to compare the efficacy of the combination of 20% albumin solution with Ringer Lactate against Ringer Lactate alone in terms of postoperative outcomes at 28 days.

The efficacy of the clinical trial titled "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" will be assessed using several parameters. The primary endpoint is the Comprehensive Complication Index (CCI score) at day 28. Secondary endpoints include the CCI score at day 7, volume of intraoperative and postoperative (48h) fluid therapy, cumulated incidence of surgical, infectious, and medical postoperative complications at 28 days, need for mechanical ventilation, renal replacement therapy between surgery and day 28, SOFA score variation between the 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, and hypersensitivity reactions to **albumin** at 133 days.

The trial will involve the administration of a 20% human **albumin** solution combined with Ringer Lactate, compared to Ringer Lactate alone, during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC). Efficacy assessments will be conducted at specified timepoints, including day 7, day 28, and 133 days post-treatment. The trial aims to evaluate the impact of the treatment on postoperative outcomes, with a focus on complication indices and overall patient recovery metrics. Data collection will be performed using validated scales and clinical assessments to ensure accurate and reliable measurement of the specified endpoints.