Effects of Continuous Postoperative Pericardial FLUshing with Investigational Device on Postoperative Re-Explorations for Bleeding (FLUID)-Randomized Clinical Trial.

Objectives: Continuous postoperative pericardial flushing (CPPF) may prevent postoperative re-explorations for tamponade or excessive postoperative bleeding due to a non-surgical cause in cardiac surgery patients. Methods: An investigator-initiated, national, multicenter, randomized clinical superiority trial was performed in four hospitals in the Netherlands between November 2021 and April 2023. Patients undergoing general cardiac surgery involving cardiopulmonary bypass were randomly assigned to receive CPPF or standard care. The primary endpoint was the number of surgical re-explorations for either cardiac tamponade or excessive postoperative bleeding due to a non-surgical cause in the first postoperative week. Results: The study was stopped after randomization of 164 patients, of which 79 were allocated to CPPF and 85 served as controls. The number of surgical re-explorations for either cardiac tamponade or excessive postoperative bleeding due to a non-surgical cause in the first postoperative week was not different between CPPF patients and control patients (3.8% vs. 2.4%; relative risk 1.61 [0.28-9.41]; p = 0.67). There were no safety issues related to use of the investigational device. Conclusions: In this prematurely stopped study, CPPF did not reduce the number of postoperative re-explorations for cardiac tamponade or excessive bleeding due to a non-surgical cause in cardiac surgery patients. Additional well-powered studies remain needed to determine whether CPPF has any beneficial effect on outcome.