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

NCT ID: NCT06351475

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-03
• Study Completion Date: 2027-10-31

Brief Summary

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 to assess the efficacy of 20% albumin combined with Ringer Lactate versus Ringer Lactate for fluid therapy during CRS with HIPEC on post operative outcome at 28 day.

Methods and analysis The study protocol has been designed and written in accordance with the Prospective randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial.

Recruitment, randomisation and allocation Information on the study and screening of patients will be conducted during the consultation of anaesthesia (= selection visit), 2 months at 3 days before the surgery. Information notice and consent form will be delivered. The day before the surgery, anaesthesiologist who will conduct the pre anaesthetic visit will be able to include patients in the study (=inclusion visit). Randomisation will be done at the inclusion visit after information and signature of consent form of voluntary patients. A randomization number will be assigned. The 1:1 randomisation will be centralized via an online interface ensuring secret group assignment, and based on predefined randomisation lists with variable-size permutation blocks, stratified by center. Randomisation will be accomplished using a computer-generated random sequence.

Randomized Open, Blinded endpoint (PROBE) design. This study is a randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial.

Intervention

• 20% Albumin + Ringer Lactate group (intervention group) Per-operative fluid therapy consisting in Ringer Lactate combined with 20% albumin. Patients will receive a bolus of 3 mL/kg on one hour of 20% albumin from anaesthetic induction. Then, infusion of 20% albumin (100 mL, 20g) will be administered for each 1200 mL of vascular filling by Ringer Lactate. Dosage of intra operative albuminemia will be realized 2 hours after the end of the bolus or infusion to ensure albuminemia is within the target concentrations (35-45 g/L). Use of 20% albumin will be realized for the entire duration of the surgery and stopped at the end of the surgery.
• Control group Ringer Lactate for intra operative fluid management based on the latest scientific recommendations. As the the study is an open labelled randomized clinical trial, placebo use is not planned.

Outcome measures The primary outcome will be the Comprehensive Complication Index (CCI score) at day 28 after CRS with HIPEC. Secondary outcomes are mortality at day 28, CCI score at day 7, volume of intra operative and post operative (48h) post operative fluid therapy, cumulated incidence of surgical post operative complications, cumulated incidence of medical post operative complications, need for mechanical ventilation, renal replacement therapy between surgery and day 28, SOFA score variation between pre operative period and 48h after surgery, number of days alive out of intensive care unit and out of hospital until day 28

Sample size calculation To ensure a power of 80%, a number of patients 130 (65 patients by group) will be necessary with a reduction of 13.6 (SD 24) points of the CCI score at day 28 in the intervention group. Because of a risk of neoplastic evolution between anaesthetic consultation and randomisation (10% of early cancellation), a total of 146 patients (73 by group) will be included in the study.

Discussion In summary, ALBUCHIP study will be the first randomized clinical trial assessing efficacy of intraoperative use of 20% albumin combined with Ringer Lactate versus Ringer Lactate during CRS with HIPEC. Results yielded from this study will be helpful for vascular filling during CRS with HIPEC but, thanks to ancillary studies, to improve pathophysiological understanding of this surgery.

Conditions

Peritoneal Neoplasms; Hyperthermic Intraperitoneal Chemotherapy; Intraoperative Care; Fluid Therapy; Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

20% Albumin + Ringer Lactate group

Per-operative fluid therapy consisting in Ringer Lactate combined with 20% albumin. Patients will receive a bolus of 3 mL/kg on one hour of 20% albumin from anaesthetic induction. Then, infusion of 20% albumin (100 mL, 20g) will be administered for each 1200 mL of vascular filling by Ringer Lactate. Dosage of intra operative albuminemia will be realized 2 hours after the end of the bolus or infusion to ensure albuminemia is within the target concentrations (35-45 g/L). Use of 20% albumin will be realized for the entire duration of the surgery and stopped at the end of the surgery.

Group Type: EXPERIMENTAL

Intra-operative albumin administration

Intervention Type: OTHER

Patients randomized in the intervention group (20% albumin + Ringer Lactate) will receive, during cytoreductive surgery with HIPEC, fluid therapy consisting in Ringer Lactate (based on a fluid management protocol specifically set up for the study, and based on latest recommendations) combined with 20% albumin. Patients randomized in the intervention group will receive a bolus of 3 mL/kg on one hour of 20% albumin from anesthetic induction . Dosage of albuminemia will be done 2 hours after the end of the bolus (target of 35-45 g/L of intra operative albuminemia). Then, infusion of 20% albumin (100 mL, 20g) will be administered for each 1200 mL of vascular filling by Ringer Lactate. Dosage of intra operative albuminemia will be realized 2 hours after the end of the bolus or infusion to ensure albuminemia is within the target concentrations (35-45 g/L). Use of 20% albumin will be realized for the entire duration of the surgery and stopped at the end of the surgery.

Control group

Ringer Lactate for intra operative fluid management based on the latest scientific recommendations. As the the study is an open labelled randomized clinical trial, placebo use is not planned.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

Ringer lactate

Interventions

Intra-operative albumin administration

Patients randomized in the intervention group (20% albumin + Ringer Lactate) will receive, during cytoreductive surgery with HIPEC, fluid therapy consisting in Ringer Lactate (based on a fluid management protocol specifically set up for the study, and based on latest recommendations) combined with 20% albumin. Patients randomized in the intervention group will receive a bolus of 3 mL/kg on one hour of 20% albumin from anesthetic induction . Dosage of albuminemia will be done 2 hours after the end of the bolus (target of 35-45 g/L of intra operative albuminemia). Then, infusion of 20% albumin (100 mL, 20g) will be administered for each 1200 mL of vascular filling by Ringer Lactate. Dosage of intra operative albuminemia will be realized 2 hours after the end of the bolus or infusion to ensure albuminemia is within the target concentrations (35-45 g/L). Use of 20% albumin will be realized for the entire duration of the surgery and stopped at the end of the surgery.

Intervention Type: OTHER

Control

Ringer lactate

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut régional du Cancer de Montpellier

Montpellier, , France

Site Status: RECRUITING

La Pitié Salpetriere hospital

Paris, , France

Site Status: RECRUITING

Lariboisière hospital

Paris, , France

Site Status: RECRUITING

Saint Louis hospital

Paris, , France

Site Status: RECRUITING

Robert Debré hospital

Reims, , France

Site Status: RECRUITING

Hôpital Hautepierre / UIC ARMO

Strasbourg, , France

Site Status: RECRUITING

Gustave Roussy Institute

Villejuif, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Arthur Moreau, Dr

Role: CONTACT

arthur.moreau@aphp.fr

142499394 ext. +33

Jérôme Lambert, Pr

Role: CONTACT

jerome.lambert@u-paris.fr

142499742 ext. +33

Facility Contacts

Lana Zoric

Role: primary

Lana.Zoric@icm.unicancer.fr

467618538 ext. +33

Alexandre Sitbon

Role: primary

alexandre.sitbon@aphp.fr

184827399 ext. +33

Nathalie Poirier

Role: primary

nathalie.poirier@aphp.fr

1 49 95 68 43 ext. +33

Arthur Moreau

Role: primary

arthur.moreau@aphp.fr

142499394 ext. +33

Ezechiel Bankole

Role: primary

ebankole@chu-reims.fr

326788801 ext. +33

Valentina FAITOT

Role: primary

valentina.faitot@chru-strasbourg.fr

388116768 ext. +33

Stéphanie Suria

Role: primary

Stephanie.SURIA@gustaveroussy.fr

142114437 ext. +33

Other Identifiers

APHP230864

Identifier Type: -

Identifier Source: org_study_id