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Cytoreductive surgery (CRS) with heated intraperitoneal chemotherapy (HIPEC) is a treatment for peritonitis carcinomatosa. These procedures often involve significant blood and fluid loss, leading to hyperdynamic circulation and vasodilation, necessitating intraoperative fluids and vasoconstrictors such as catecholamines. Excessive fluid administration to counteract vasodilation can cause intraoperative fluid overload, which is linked to increased postoperative complications. Vasopressin has emerged as a potential alternative to catecholamines, restoring vascular tone via non-adrenergic pathways and supporting perfusion pressure, potentially reducing the need for compensatory fluids solely administered to compensate for vasodilation. We hypothesise that compared with norepinephrine, vasopressin reduces cumulative intraoperative fluid administration during CRS-HIPEC within a goal-directed fluid therapy (GDFT) protocol, ultimately leading to a lowering of postoperative complications.
HiPress is a two-centre, two-arm randomised clinical trial with blinding of both patients and outcome assessors. A total of 70 adult patients undergoing CRS-HIPEC will be included. Patients will be randomised to receive either continuous low-dose argipressin or continuous low-dose norepinephrine. Both groups will receive standardised GDFT during the procedure. The primary endpoint is cumulative intraoperative fluid administration (mL). Secondary endpoints include direct fluid-related outcomes (eg, cumulative intraoperative fluid (ml/kg/hour), postoperative fluid balance until day five and ultrasound-assessed pulmonary oedema and venous congestion) and indirect fluid-associated outcomes (eg, quality of recovery, surgical and abdominal complications, acute kidney injury (AKI), pulmonary complications, length of ICU and hospital stay and 30-day mortality).
The study is enrolling patients since February 2025. The trial is approved by the Medical Research Ethics Committee (hereinafter: MREC) NedMec, The Netherlands (Ref: D-25-500202). Results of the trial will be published in an international peer-reviewed journal and announced at national and international scientific meetings.
Clinical Trials Information System (CTIS): European Union clinical trials register (EUCT) number: 2024–5 13 598-33-00
by Elisabeth G. van der Hulst, Kenneth Meijer, Pieter Meyns, Christopher McCrum
Training fall-resisting skills can prevent falls in older adults. These fall-resisting skills include proactive gait adaptability, gait robustness, and reactive gait recovery, which allow people to effectively avoid, resist, and recover from balance threats, respectively. This pilot study guided the design of an RCT of fall-resisting skills training by investigating key design factors, such as the design of a placebo-control group, obstacle difficulty settings, exploring evaluation methods for gait robustness, testing the effect of task unpredictability on anxiety, and the general feasibility. Eleven healthy older adults performed non-task-specific “placebo” balance tasks and assessment and training tasks for each fall-resisting skill. Placebo tasks included static weight-shifting exercises and dual-task walking. For the fall-resisting skill tasks, participants walked on a treadmill under different conditions. For proactive gait adaptability, participants avoided projected obstacles varying in size, approach speed, and available response time. Gait robustness was assessed using perturbations of increasing magnitude, where the margin of stability following each perturbation was compared with participants’ perceived balance loss and researchers’ observations. For reactive gait recovery, perturbations with increasing unpredictability were applied, after which participants reported their anxiety scores. Weight-shifting tasks were perceived as balance training by most participants, indicating their potential as placebo tasks. Obstacle avoidance difficulty increased most with fast approach speed and large obstacle sizes. A margin of stability-based threshold did not consistently align with perceived balance loss or observer judgement. Anxiety did not increase with more unpredictable perturbation tasks when introduced gradually. Fall-resisting skill tasks generally were feasible for older adults.
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