Condition: Peritoneal Neoplasms · Hyperthermic Intraperitoneal Chemotherapy · Intraoperative Care · Sponsor: Assistance Publique - Hôpitaux de Paris
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. Inf…
This description comes directly from the study's public registry record.
Arthur Moreau, Dr · 142499394 · arthur.moreau@aphp.fr
Jérôme Lambert, Pr · 142499742 · jerome.lambert@u-paris.fr
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| Institut régional du Cancer de Montpellier | Montpellier, France | Recruiting |
| La Pitié Salpetriere hospital | Paris, 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 |
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Source record: clinicaltrials.gov/study/NCT06351475