ALBUCHIP20% Albumin and Ringer Lactate for Cytoreductive Surgery with HIPEC Patients
The study aims to observe the effect of 20% Albumin and Ringer Lactate on reducing complications in patients undergoing cytoreductive surgery with heated chemotherapy.
Intra-operative albumin administration
+ Control
Abdominal Neoplasms+7
+ Digestive System Diseases
+ Digestive System Neoplasms
Treatment Study
Summary
Study start date: September 3, 2025
Actual date on which the first participant was enrolled.This study focuses on patients undergoing a specific type of cancer surgery called cytoreductive surgery followed by heated chemotherapy delivered directly into the abdomen, known as HIPEC. During this procedure, a large amount of fluid is often needed to manage body functions affected by surgery. The study aims to compare the effectiveness of using a combination of 20% human albumin and Ringer Lactate against using only Ringer Lactate for fluid management during the surgery. This research is important because it explores whether using albumin can lead to better recovery outcomes and fewer complications after surgery, which could ultimately improve patient care. Participants in the study will be randomly divided into two groups. One group will receive a combination of Ringer Lactate and 20% albumin as part of their fluid therapy during surgery. The albumin will be given as an initial dose followed by an infusion during the operation. The control group will receive only Ringer Lactate based on current medical guidelines. Researchers will evaluate the effectiveness of these treatments by looking at various outcomes, such as complication rates, recovery times, and the need for additional medical interventions up to 28 days after the surgery. This trial is designed to provide insight into which fluid therapy approach might offer the best post-surgical outcomes.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.140 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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: * Adults \>75 years old * Functional status rendering the patient ineligible for cytoreduction with CHIP (ECOG \> 2 or Karnofsky index \< 75) * Pre-existing preoperative conditions affecting albuminemia (hepatic cirrhosis, nephrotic syndrome, exudative enteropathy, malnutrition) * Severe preoperative hypoalbuminemia (albuminemia \< 20 g/L) * History of chronic left heart failure with reduced left ventricular ejection fraction (left ventricular ejection fraction \< 40%) * Patients at high risk of perioperative and postoperative pulmonary complications (atelectasis, significant pleural effusions) * Significant ascites with preoperative respiratory repercussions * Uncontrolled diabetes (HbA1c \> 8.5%) * Allergy to exogenous human albumin and its excipients. * Contraindication to the administration of Ringer's lactate (history of allergy) * Hyperkalemia \> 6.0 mmol/L * Hypercalcemia (total calcium \> 2.60 mmol/L) * Chronic use of digitalis and hyperkalemic diuretics * Pregnancy, breastfeeding * Known preoperative renal failure (GFR \< 30 mL/min/1.73m2 or extrarenal purification) * Recent brain trauma \< 6 months (traumatic, ischemic, or hemorrhagic) * Participation in another interventional study involving human subjects or being in the exclusion period following a previous study involving human subjects, if applicable * Patient deprived of liberty * Patient under guardianship or curatorship
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
Institut régional du Cancer de Montpellier
Montpellier, FranceOpen Institut régional du Cancer de Montpellier in Google MapsLa Pitié Salpetriere hospital
Paris, FranceLariboisière hospital
Paris, FranceSaint Louis hospital
Paris, France