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

NCT06351475 | Recruiting DMC

• 1 other identifier: APHP230864
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 7

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

Keywords

Cytoreductive surgery; Hyperthermic intraperitoneal chemotherapy; Albumin administration; Fluid therapy; Post operative prognosis; Randomized clinical trial; Open label clinical trial

Outcome Measures

Primary Outcomes (1)

• Comprehensive Complication Index score

  The Comprehensive Complication Index (CCI) is a score ranging from 0 to 100, calculated using all complications and their treatment after abdominal surgery. The CCI is that it is a linear scale ranging from 0 to 100, where 100 represents death

  At day 28

Secondary Outcomes (15)

• Comprehensive Complication Index score

  At day 7

• Volume of intra operative and post operative fluid therapy

  48 hours after surgery

• Cumulative incidence of surgical post operative complications

  Up to day 28

• Incidence of infectious complications

  Up to day 28

• Number of days under mechanical ventilation outside the operating room

  Up to day 28

Study Arms (2)

20% Albumin + Ringer Lactate group

EXPERIMENTAL

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.

Other: Intra-operative albumin administration

Control group

ACTIVE COMPARATOR

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.

Other: Control

Interventions

Intra-operative albumin administration 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.

20% Albumin + Ringer Lactate group

Control OTHER

Ringer lactate

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (7)

Institut régional du Cancer de Montpellier

Montpellier, France

RECRUITING

La Pitié Salpetriere hospital

Paris, 75013, 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

MeSH Terms

Conditions

Peritoneal Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Arthur Moreau, Dr

CONTACT

142499394; arthur.moreau@aphp.fr

Jérôme Lambert, Pr

CONTACT

142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: September 3, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

FR (7)