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Arginine

Patients will be treated with Empressin® 0.8 U/ml, 0.056 ml/kg/h during surgery.

Patients will receive normal saline 0.056 ml/kg/h during surgery.

Infusion of Argipressin 0.8 U/ml, 0.056 ml/kg/h will be started as soon as the central line is placed, and continued until the end of surgery in the treatment arm.

Argipressin

Infusion of Normal Saline 0.056 ml/kg/h will be started as soon as the central line is placed, and continued until the end of surgery in the placebo arm.

Placebo

Ellinor Wisen, MD

kristina svennerholm, MD PhD

Kristina Svennerholm, MD PhD

Ellinor Wisén, MD

Kristina Svennerholm, MD, PhD

Andreas Kvarnström, MD, PhD

Lena Sand, MD, PhD

Magnus Rizell, MD, PhD

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.

Hepatic resection is a major surgical intervention with high risk of substantial blood loss. The surgical means to reduce blood loss may impair perfusion and induce intestinal congestion. If blood flow to the liver can be influenced by pharmacological means, blood loss and transfusion requirements may be reduced. Moreover, the inflammatory system is involved in cancer development, and the anti-inflammatory properties of Argipressin may decrease the inflammatory response after hepatic surgery.

Argipressin is an endogenous substance, and part of the body's response to stress and trauma. Argipressin affects V1-receptors to produce vasoconstriction. It is also involved in inflammatory reactions and affects platelets.

Patients will be stratified according to planned type of surgery (open/laparoscopic) and planned extent of resection, and randomized to etiher infusion of Argipressin or placebo (normal saline) during surgery. In all other aspects, the participants will be treated according to the institution protocol for hepatic resection. The study drug will be started as soon as the central line is placed, and discontinued at the end of surgery. Hemodynamic data will be collected during surgery, and blood and urine-samples will be obtained during and after surgery for analysis of inflammatory markers and markers of organ injury.

Singel center double-blinded, randomized, placebo-controlled trial.

Randomisation will be handled by a nurse not involved in the study, and both the patient, treating physician and nurse, the study nurse and the investigators will be blinded to the study treatment.

Argipressin's Influence on Blood Loss During Hepatic Resection

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

Metadata will be shared by the Swedish National Data Service (SND, https://snd.gu.se/en) and selected psedonymised data will be made available on reasonable request, after proper confidentiality and ethics assessment. As the study is still ongoing, the extent of data made available will be decided after study closure, and also the time span for availability.

Blood loss at the end of surgery, measured according to the investigator's instructions, by visual assessment of suction devises and gauze, and subtraction of ascites and irrigation fluids.

Blood transfusion (ml) at the end of surgery and at postoperative day 1 and 2 and 5 respectively.

Levels of White Blood Cell count, C Reactive Protein, Platelet count and Albumin at the end of surgery and postoperative day 1-5

Levels of Interleukin (IL)-1 Beta, IL-6, IL-8, IL-10, Monocyte chemoattractant protein-1, Stromal Cell-Derived Factor-1 alpha, Intercellular Adhesion Molecule, Complement (C) 3a, C5b-9 at the end of surgery and postoperative day 1 and 2.

duration of Pringles manouvre (min), duration of resection phase (min) and surgery (min)

achievement of CVP (central venous pressure) goal (mmHg), as recorded on the Phillips monitor.

Total use of noradrenaline (micrograms/minutes of surgery/ bodyweight)

Postoperative complications including death and radicality of resection at 30-day follow up.

Change in plasma creatinine (micro-mole/L)

Change in urine creatinine and urine \[TIMP-2\] x \[IGFBP-7\] (quota, no unit)

Spots Global Cancer Trial Database for colon cancer metastasis