Influence of Argipressin on Blood Loss During Hepatic Resection; a Double-blinded, Randomized Placebo-controlled Trial (ARG-01)

ARG-01

Infusion of Argipressin during hepatic resection surgery may reduce blood loss. It may also reduce transfusion requirements, and mitigate the perioperative inflammatory response compared to placebo. Subjects will be randomized to infusion of Argipressin or placebo during surgery. Blood loss, transfusion requirements, surgical data including length of stay in hsopital, inflammatory markers and markers of renal- intestinal- and cardiac injury will be assessed.

2022-03-27

2024-12-01

2025-03-01

Recruiting

Early phase I

248

Inclusion Criteria: 1. Participant planned for hepatic resection (open or laparoscopic, regardless of indication for surgery). 2. Age ≥18 years. 3. ASA class I-III. 4. Signed informed consent form Exclusion Criteria: 1. Participant does not understand the given information, and/ or cannot give written informed consent. 2. Simultaneous operation of tumor with other localization, or surgery for superficial single hepatic tumor less than 2 cm, expected to be of short duration and with minimal blood loss. 3. Terminal kidney failure (estimated preoperative GFR\< 15 ml/min) 4. Pregnancy or lactation. 5. Known allergy to Empressin®. 6. Patient included in other interventional study, interacting with the endpoints in the present study, or previous randomization in this study. 7. Hyponatremia (S-Na \< 130 mmol/L) 8. Patient considered ineligible for other surgical or medical reason. 9. Present infection. Patients with systemic inflammatory disease, inflammatory bowel disease or preoperative corticosteroid treatment will not be eligible for the subgroups where cytokines and interleukins are investigated.

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2023-07-13