Using 20% albumin with Ringer's lactate during cytoreductive surgery and HIPEC.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hôpital Lyon Sud Pierre Bénite
  Lyon, France Recruiting
• 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

Study contacts

• Study coordinator: Arthur Moreau, Dr
• Email: arthur.moreau@aphp.fr
• Phone: 142499394

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.