Informations générales (source: ClinicalTrials.gov)
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
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
septembre 2025
octobre 2027
30 septembre 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | St�phanie SURIA | 27/05/2026 11:50:05 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | Alexandre Sitbon | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hôpital Lyon Sud Pierre Bénite - Lyon - France | Anne Li | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Gustave Roussy Institute - Villejuif - France | Stéphanie Suria | Contact (sur clinicalTrials) | |||
| Hôpital Hautepierre / UIC ARMO - Strasbourg - France | Valentina FAITOT | Contact (sur clinicalTrials) | |||
| Institut régional du Cancer de Montpellier - Montpellier - France | Lana Zoric | Contact (sur clinicalTrials) | |||
| Lariboisière hospital - Paris - France | Nathalie Poirier | Contact (sur clinicalTrials) | |||
| Robert Debré hospital - Reims - France | Ezechiel Bankole | Contact (sur clinicalTrials) | |||
| Saint Louis hospital - Paris - France | Arthur Moreau | Contact (sur clinicalTrials) | |||
Critères
Tous
- 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