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

RecruitingNAAges 18 Years - 80 YearsAllAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

Introduction Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is considered as the standard of care for the treatment of peritoneal metastases. Cytoreductive surgery with HIPEC is characterized by large intra operative fluid shift secondary to surgical resection, peritoneal inflammation and capillary shifts, requesting high volume of intra operative fluid therapy. Previous studies found a strong association between intra operative hypovolemia or volume overload with post operative outcomes. Albumin as an intravenous fluid has been widely studied in critical ill patients, but evaluation of its efficacy during major surgery on post operative clinical outcomes are lacking. We hypothesize that a reduction of intra operative crystalloid volume infusion by using 20% albumin during CRS with HIPEC could improve patients' prognosis. The aim of this study will be

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📋 Eligibility rules (as published)
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
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What it tests

  • Intra-operative albumin administration
  • Control
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Where

8 sites
Hôpital Lyon Sud Pierre Bénite
Lyon, France
Institut régional du Cancer de Montpellier
Montpellier, France
La Pitié Salpetriere hospital
Paris, France
Lariboisière hospital
Paris, France
Saint Louis hospital
Paris, France
Robert Debré hospital
Reims, France
Hôpital Hautepierre / UIC ARMO
Strasbourg, France
Gustave Roussy Institute
Villejuif, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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