Evaluation of Human Albumin Solution Versus Electrolyte Solution for Plasma Volume and Hemodynamic Optimization in Laparoscopic Surgery Patients

The primary objective of this study is to evaluate the effect of **fluid therapy** using albumin and Ringer's solution on plasma volume and hemodynamics during laparoscopic surgery. This is particularly relevant in the context of modern surgical techniques where intra-abdominal CO2 inflation may reduce preload, necessitating careful management of fluid volume to optimize patient outcomes. The study aims to provide insights into the efficacy of these solutions in maintaining hemodynamic stability, which is crucial for patient safety and recovery during and after surgery.

The clinical trial involves a study population comprising both **male** and **female** participants, aged between 18 to 80 years. The participants are generally in good health, classified under the American Society of Anesthesiology (ASA) classification I to III, indicating they are suitable for undergoing planned major laparoscopic abdominal surgery lasting 90 minutes or more. The trial does not include a vulnerable population. Participants were selected based on their ability to provide written consent and, for females of childbearing potential, the use of adequate contraception or a negative pregnancy test. The sponsor has not provided information regarding the total number of participants. The study focuses on the effects of **fluid therapy** in combination with laparoscopic surgery, highlighting the impact of fluid bolus in modern surgical practices where reduced preload due to intra-abdominal CO2 inflation demands additional fluid volume. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the efficacy of **fluid therapy** during combination laparoscopic surgery, specifically comparing the effects of **albumin** and **Ringer's solution** on plasma volume and hemodynamics. This study is structured as a randomized, double-blind, controlled trial, ensuring that neither the participants nor the researchers know which treatment is being administered, thus minimizing bias. The trial is expected to commence on October 23, 2023, and conclude by December 31, 2025, with the total duration of participant involvement being approximately one day, as the maximum treatment period is limited to one day.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on criteria such as age (18 to 80 years), ASA classification (I to III), and planned laparoscopic surgery duration of 90 minutes or more. Female participants of childbearing potential must use adequate contraception or have a negative pregnancy test. Following the screening, eligible participants will be randomized to receive either **sodium lactate solution** with other electrolytes or **human albumin solution** via intravenous infusion during surgery. The primary endpoint is the reduction in hemoglobin levels associated with fluid bolus, analyzed using a kinetic model. Secondary endpoints include circulatory physiological measurements and changes in P-albumin, P-creatinine, fluid composition, and fluid balance preoperatively and 24 hours postoperatively.

Participants will be monitored closely throughout the trial, with follow-up visits scheduled to assess the primary and secondary endpoints. The end-of-study visit will occur after the completion of the 24-hour postoperative period. Conditions that may lead to early termination from the study include withdrawal of consent, adverse events, or any situation where continued participation is deemed unsafe by the investigator. The trial aims to provide valuable insights into the optimization of fluid therapy during laparoscopic surgery, contributing to improved surgical outcomes and patient safety.

The clinical trial involves the administration of two experimental medications. The first experimental medication is a **fluid infusion** containing a combination of **sodium lactate solution**, **magnesium chloride hexahydrate**, **potassium chloride**, **sodium chloride**, and **calcium chloride dihydrate**. This formulation is classified under the ATC code B05BB01, which pertains to **electrolytes**. The pharmaceutical form of this medication is denoted as PHF00230MIG. The medication is administered via **intravenous use** with a maximum daily dose of 3 liters and a maximum total dose of 3 liters over a treatment period of 1 day. The active substances are of chemical origin, and the medication is not a pediatric formulation.

The second experimental medication is a **fluid infusion** of **human albumin solution**, classified under the ATC code B05AA01, which pertains to **albumin**. The pharmaceutical form is also PHF00230MIG. This medication is administered intravenously with a maximum daily dose of 50 grams and a maximum total dose of 50 grams over a treatment period of 1 day. The active substance, human albumin solution, is a structurally diverse substance derived from blood. This medication is also not a pediatric formulation.

Efficacy in the clinical trial titled "Comparison of albumin and Ringer’s solution for optimization of the plasma volume and hemodynamics during surgery" will be assessed using specific primary and secondary endpoints. The primary endpoint is the reduction in **hemoglobin** levels associated with fluid bolus administration, which will be mathematically processed using a kinetic model. Secondary endpoints include circulatory physiological measurements, changes in plasma albumin (P-albumin), plasma creatinine (P-creatinine), fluid composition, and fluid balance both preoperatively and 24 hours postoperatively. These parameters will be collected and analyzed to evaluate the efficacy of the interventions in optimizing plasma volume and hemodynamics during surgery.