MANNITOL for Peritoneal carcinomatosis

Inclusion criteria

• {"criterion_text":"- 18 years old and older\n- Planned cytoreductive surgery with HIPEC for peritoneal carcinomatosis (from gynaecological or digestive origin)\n- Patient volunteer for the study and provided written informed consent\n- Patient affiliated to the French Health Insurance"}

Exclusion criteria

• {"criterion_text":"- Pre-operative disease influencing plasmatic albumin levels (hepatic cirrhosis, nephrotic syndrome, exudative enteropathy, severe denutrition)\n- Hyperkaliemia > 6.0 mmol/L\n- Hypercalcemia > 2.60 mmol/L\n- Chronic use of digitalis and hyperkalemic diuretics\n- Pregnancy, Breast feeding\n- Aged > 75 years old\n- Functional status making the patient ineligible for cytoreduction with CHIP (ECOG > 2 or Karnofsky scale < 75)\n- Patients at high risk of intra- and post-operative pulmonary complications (atelectasis, large pleural effusions)\n- Significant ascites with preoperative respiratory impact\n- Unbalanced diabetes (HbA1c > 8.5%)\n- Recent cerebral trauma < 6 months (of traumatic, ischemic or hemorrhagic origin)\n- Chronic kidney disease (estimated glomerular filtration rate < 30 mL/min/1.73m2 or need for renal replacement therapy)\n- Participation in another interventional research project or being in the exclusion period following a previous research project\n- Patient deprived of liberty\n- Patient under guardianship\n- Severe pre-operative Hypoalbuminemia (albuminemia < 20g/L)\n- Chronic heart failure with reduced ejection fraction (left ventricular ejection fraction < 40%)\n- Allergy to exogen human albumin\n- Allergy to Ringer Lactate"}

Primary endpoints

• {"endpoint_text":"- Comprehensive Complication Index (CCI score) at day 28","definition_or_measurement_approach":"Comprehensive Complication Index (CCI) measured at postoperative day 28."}

Secondary endpoints

• {"endpoint_text":"- CCI score at day 7","definition_or_measurement_approach":"Comprehensive Complication Index (CCI) measured at postoperative day 7."}
• {"endpoint_text":"- volume of intra operative and post-operative (48h) post-operative fluid therapy","definition_or_measurement_approach":"Total volume of vascular filling in ml/kg/h during the intra-operative period and during the first 48 postoperative hours (H48)."}
• {"endpoint_text":"- cumulated incidence of surgical post-operative complications at 28 days","definition_or_measurement_approach":"Cumulative incidence of surgical complications assessed at day 28 postoperatively."}
• {"endpoint_text":"- cumulated incidence of infectious post-operative complications at 28 days","definition_or_measurement_approach":"Cumulative incidence of infectious postoperative complications assessed at day 28."}
• {"endpoint_text":"- cumulated incidence of medical post-operative complications at 28 days","definition_or_measurement_approach":"Cumulative incidence of medical postoperative complications assessed at day 28."}
• {"endpoint_text":"- need for mechanical ventilation","definition_or_measurement_approach":"Number of days patients were on mechanical ventilation outside the operating room."}
• {"endpoint_text":"- renal replacement therapy between surgery and day 28","definition_or_measurement_approach":"Number of days patients were on renal replacement therapy between surgery and day 28."}
• {"endpoint_text":"- SOFA score variation between pre-operative period and 48h after surgery","definition_or_measurement_approach":"Variation in SOFA score between the pre-operative period and 48 hours after surgery."}
• {"endpoint_text":"- number of days alive out of intensive care unit and out of hospital until day 28","definition_or_measurement_approach":"Number of days alive outside the intensive care unit and number of days alive at home up to day 28."}
• {"endpoint_text":"- mortality at day 28","definition_or_measurement_approach":"Cumulative incidence of death in intensive care and hospital by day 28."}
• {"endpoint_text":"- Hypersensitivity reactions to albumin at 133 days","definition_or_measurement_approach":"Proportion of patients presenting allergic complications to albumin assessed at day 133."}

France

Earliest CTIS Part Ii Submission Date

17-02-2025

Latest Decision Or Authorization Date

27-08-2025

Processing Time Days

191

Number Of Sites

7

Number Of Participants

140

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France