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

Introduction Cytoreductive 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.