Using 20% albumin with Ringer's lactate during cytoreductive surgery and HIPEC.
Evaluation de l'efficacité du Remplissage Vasculaire Par de l'ALBUmine Humaine 20% + Ringer Lactate comparé au Ringer Lactate Seul Chez Les Patients opérés Par cytoréduction Avec CHimiothérapie Intrapéritonéale hyPerthermique
This study will test whether adding 20% albumin to Ringer's lactate during cytoreductive surgery with HIPEC for adults with peritoneal carcinomatosis reduces the need for crystalloid fluids and improves postoperative outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Montpellier and 6 other locations) |
| Trial ID | NCT06351475 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares intraoperative administration of concentrated 20% albumin combined with Ringer's lactate versus Ringer's lactate alone during cytoreductive surgery with HIPEC. The albumin arm is intended to reduce the total crystalloid volume given during the procedure, and perioperative fluid balance and postoperative complications will be recorded. Eligible adults (18–75) planned for CRS with HIPEC and affiliated with French health insurance will be enrolled, while patients with severe hypoalbuminemia, significant liver or kidney disease, reduced cardiac function, or high pulmonary risk are excluded. The protocol is carried out at participating centers in Paris and Montpellier.
Who should consider this trial
Good fit: Adults aged 18–75 with peritoneal carcinomatosis scheduled for cytoreductive surgery with HIPEC who are medically fit for major surgery and do not have conditions that affect albumin levels are the ideal candidates.
Not a fit: Patients over 75, those with severe hypoalbuminemia, liver cirrhosis, nephrotic syndrome, significant cardiac or pulmonary disease, or large symptomatic ascites are unlikely to benefit or are excluded from participation.
Why it matters
Potential benefit: If successful, adding 20% albumin could lower crystalloid requirements and reduce fluid-related postoperative complications after CRS with HIPEC.
How similar studies have performed: Albumin has been widely studied in critically ill patients with mixed results, while intraoperative use during major oncologic procedures like CRS with HIPEC has not been well tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montpellier and 6 other locations
- Institut régional du Cancer de Montpellier — Montpellier, France (Recruiting)
- La Pitié Salpetriere hospital — Paris, France (Recruiting)
- Lariboisière hospital — Paris, France (Recruiting)
- Saint Louis hospital — Paris, France (Recruiting)
- Robert Debré hospital — Reims, France (Recruiting)
- Hôpital Hautepierre / UIC ARMO — Strasbourg, France (Recruiting)
- Gustave Roussy Institute — Villejuif, France (Recruiting)
Study contacts
- Study coordinator: Arthur Moreau, Dr
- Email: arthur.moreau@aphp.fr
- Phone: 142499394
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.