Efficacy of intraoperative use of 20% albumin in combination with Ringer's lactate versus Ringer's lactate during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy: protocol for a randomised controlled, open-label clinical trial (ALBUCHIP trial).

introductionCytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is considered the standard of care for the treatment of peritoneal metastases from gastrointestinal and gynaecological cancers. Characterised by substantial intraoperative fluid shifts and increased endothelial permeability, this procedure is associated with adverse perioperative outcomes. Human albumin has been extensively studied in critically ill patients as an intravenous fluid, but its efficacy during major non-cardiac surgery involving substantial fluid requirements remains insufficiently evaluated. The aim of this trial is to evaluate the efficacy of 20% albumin in combination with Ringer's lactate versus Ringer's lactate alone for fluid therapy during CRS with HIPEC in relation to postoperative outcomes. METHODS AND ANALYSIS: The study protocol was designed and written in accordance with the Prospective Randomised Open, Blinded Endpoint design and followed the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) recommendations. This is a randomised controlled, open-label parallel-group multicentre clinical trial. Participants will be patients admitted for CRS with HIPEC. Eligible patients will be randomly assigned to either the control group (Ringer's lactate) or the intervention group (20% albumin+Ringer's lactate) in a 1:1 ratio, with stratification by centre. The primary outcome is the Comprehensive Complication Index (CCI) score at day 28 following CRS with HIPEC. Secondary endpoints include mortality at day 28, CCI score at day 7, volume of intraoperative and postoperative (48 hours) fluid therapy, cumulative incidence of surgical and medical postoperative complications, and number of days alive and out of the hospital by day 28. To ensure 90% power, a total of 140 patients (70 per group) are required to detect a 13.6-point reduction in the CCI score on day 28 in the intervention group, assuming a SD of 24. ETHICS AND DISSEMINATION: The study has been authorised by the Clinical Trials Information System and approved by the European Ethical Committee (EU CT number 2024-5 10 943-76-00). Clinicians will explain the details of the study to all eligible participants. Written informed consent will be obtained from all participants prior to randomisation. The results of the study will be communicated to healthcare professionals and the public through presentations at international scientific conferences and publication in peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: The trial has been registered on ClinicalTrials.gov (NCT06351475).