Argipressin 40units/2ml solution for injection ampoules

INTRODUCTION: Liver resection carries a high risk for extensive bleeding and need for blood transfusions, which is associated with significant negative impact on outcome. In malignant disease, the most common indication for surgery, it also includes increased risk for recurrence of cancer. Argipressin decreases liver and portal blood flow and may have the potential to reduce bleeding during liver surgery, although this has not been explored. METHOD AND ANALYSIS: ARG-01 is a prospective, randomised, placebo-controlled, double-blinded study on 248 patients undergoing liver resection at Sahlgrenska University Hospital, Sweden. Patients will be randomised to one of two parallel groups, infusion of argipressin or normal saline administered peroperatively. The primary endpoint is peroperative blood loss. Secondary outcomes include need for blood transfusion, perioperative variables, length of hospital stay, the inflammatory response, organ damage markers and complications at 30 days. ETHICS AND DISSEMINATION: The study is enrolling patients since March 2022. The trial is approved by the Swedish Ethical Review Authority (Dnr 2021-03557) and the Swedish Medical Product Agency (Dnr 5.1-2021-90115). Results will be announced at scientific meetings and in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT05293041 and EudraCT, 2021-001806-32.

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<h2>Abstract</h2><h3>Background</h3> Blood loss and blood transfusion are associated with negative short-term and long-term outcomes in hepatic resection. Vasopressin decreases portal blood flow and could reduce bleeding during liver surgery. We compared the effects of argipressin and placebo on blood loss and blood transfusions in adult patients undergoing hepatic resection. <h3>Methods</h3> A single-centre, randomised, placebo-controlled, double-blind trial was conducted at Sahlgrenska University Hospital, Sweden. Adult male and female patients undergoing hepatic resection were randomised to infusion of argipressin 0.8 U ml⁻¹ i.v. or placebo, at a rate of 0.056 ml kg⁻¹ h⁻¹ (i.e. 3.6 U h⁻¹ for 80 kg) during surgery. The primary outcome was blood loss (ml) during surgery. Secondary outcomes included transfusion requirements and complications at postoperative day 30. <h3>Results</h3> The primary analysis included 245 participants. Baseline characteristics were similar between the groups. Median blood loss was 450 ml in the argipressin group (<i>n</i>=119) <i>vs</i> 500 ml in the placebo group (<i>n</i>=126) (adjusted relative risk 0.90, 95% confidence interval [CI] 0.70–1.17, <i>P</i>=0.44). Red blood cell transfusion occurred in 43 patients (36.8%) in the argipressin group and 52 patients (41.3%) in the placebo group (adjusted odds ratio [aOR] 0.84, 95% CI 0.48–1.49, <i>P</i>=0.56). Patients randomised to argipressin had fewer postoperative complications than those randomised to placebo (45 [38.8%] <i>vs</i> 72 [58.1%]; aOR 0.43, 95% CI 0.25–0.74, <i>P</i>=0.0025). <h3>Conclusions</h3> Perioperative treatment with argipressin did not reduce blood loss or transfusion requirements in hepatic resection. The incidence of postoperative complications appeared to be lower in the argipressin group. <h3>Clinical trial registration</h3> NCT05293041.

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INTRODUCTION: 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. METHODS AND ANALYSIS: 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). ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: Clinical Trials Information System (CTIS): European Union clinical trials register (EUCT) number: 2024-5 13 598-33-00.

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Introduction The hemodynamic management of septic patients involves initial fluid therapy, followed by the use of vasoconstrictors in case of treatment failure. The latest Surviving Sepsis Campaign guidelines suggest the synergistic use of argipressin in addition to norepinephrine when hemodynamic optimization is not achieved with norepinephrine alone. Methods In our single-center retrospective observational study, the primary endpoint is the safety of initial norepinephrine-argipressin association treatment, assessed through a reduction in Resistance Index. Our secondary endpoint includes the efficacy of this combination, measured by an increase in Mean Arterial Pressure and a reduction in Resistance Index as an indicator of organ perfusion. The Resistance Index (RI) is evaluated through Power Doppler ultrasound. RI is crucial for assessing multi-district vascular tone and multiorgan perfusion. Patients were categorized into three groups based on their treatment. In Group 1, we analyzed patients treated with norepinephrine alone in incremental doses; in Group 2, we analyzed patients receiving the initial norepinephrine-argipressin association treatment (norepinephrine 0.05 mcg/kg/min-argipressin 0.03 IU/min); in the third group (Group 3), we analyzed patients given argipressin (0.03 IU/min) after norepinephrine (&amp;lt;0.10–0.25≥ mcg/kg/min) to stabilize their hemodynamics (MAP &amp;gt; 65 mmHg). RI measurements were taken in the Renal Artery (ARE), Radial Artery (AR), Central Retinal Artery (CRA), and Superior Mesenteric Artery (AMS) at four different time points: T0 before vasopressor therapy, T1 at 1 h, T2 at 24 h, and T3 at 48 h after vasopressor infusion. Results A total of 48 patients were divided into three groups: 17 patients in Group 1, 16 in Group 2, and 15 in Group 3. In Group 1, an increase in Mean Arterial Pressure (MAP) was observed, but there was an increase in RIs in the right CRI and left ARE. In Group 2, there was an improvement in MAP and a reduction in RIs in the right/left CRI, left ARE, AMS, and right AR. In Group 3, there was an increase in MAP and a reduction in RIs in the right/left CRI, left ARE, AMS, and right AR. Conclusion Early norepinephrine-argipressin association treatment appears to be a valid strategy for hemodynamic optimization in this patient population.

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OBJECTIVE This video presentation demonstrates an evidence-based approach on the surgical steps of a laparoscopic myomectomy for a multi-fibroid uterus. DESIGN We are presenting a video demonstrating the steps of the surgery and the technique with narration. PATIENT We are presenting a case of a 34-year-old nulliparous patient with a history of primary infertility. The patient had a history of three unsuccessful embryo transfers. She was otherwise medically fit and well and had no previous surgeries. Her magnetic resonance imaging pelvis showed three uterine fibroids. The dominant fibroid was 6.5 cm × 6.9 cm in size, arising from the posterior wall of the uterus. There were two intramural fibroids at the fundal area with the largest measuring 3.1 cm × 3.3 cm [Figure 1]. The evidence for myomectomy before In-Vitro-Fertilisation (IVF) treatment was discussed, and the patient was counseled that surgery for intramural fibroids, not distorting the endometrial cavity, might not improve the chance of live birth.[1,2] However, given her history of recurrent implantation failure and the patient’s wish, it was agreed to proceed to surgery.Figure 1: Pelvic magnetic resonance imaging demonstrating the fibroids/Traction-counter traction maneuver with myomectomy screw http://www.apagemit.com/page/video/show.aspx?num=1370&kind=2&page=1INTERVENTIONS Laparoscopic myomectomy is safe and efficient, offering a quicker recovery, comparing to open approach, without increasing the risk of complications.[3] Following standard insertion of a 10 mm intraumbilical, a 5 mm right iliac fossa, a 10 mm and a 5 mm left iliac fossa laparoscopic ports, diluted argipressin was injected beneath the fibroid pseudocapsules. The uterine blanching due to vasoconstriction is observed, achieving adequate hemostasis.[4,5] Uterine artery ligation is not needed in this case.[6] An ultrasonic scalpel is used for the fibroid enucleation, aiming to reduce blood loss.[7] Careful dissection is employed to avoid breaching the endometrial cavity. Three fibroids are enucleated with traction and counter-traction maneuvers through two uterine incisions, using a myomectomy screw and claw graspers [Figure 1]. The use of barbed sutures to close the uterine bed facilitates a shorter operating time and reduces blood loss.[8] In-bag power morcellation (LiNA Xcise™ and Espiner ECO-T Containment Bag) through the left iliac fossa, incision is used to retrieve the specimens reducing the risk of developing parasitic fibroids[9] and offering protection in the rare event of an undiagnosed sarcoma.[10-13] Hyaluronic acid gel is applied on the uterine incisions to prevent intra-abdominal adhesions.[14-16] Three fibroids were removed with a total weight of 154 g. The procedure lasted approximately 2 hours. The patient was discharged the next day. There is insufficient data to advise a minimal time interval between myomectomy and conception.[17] The patient was advised to delay conception for a minimum of 3 months. CONCLUSION This video emphasizes that laparoscopic myomectomy is a safe and effective option for women who wish to retain fertility, with advantages such as shorter recovery time, less pain, and better cosmetic results than open surgery. Laparoscopic myomectomy surgical and fertility outcomes are comparative with robotic and superior to abdominal myomectomy.[18] The use of vasoconstrictive agents, ultrasonic scalpel, myoma screw, barbed sutures, and in-bag power morcellation is recommended to facilitate a successful procedure. Ethics statement This study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and its amendments. The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient has given her consent for her images and other clinical information to be reported in the journal. The patient understands that her name and initials will not be published and due efforts will be made to conceal identity, but anonymity cannot be guaranteed. Author contributions D.M., T.M. and N.T. Conceived the idea and jointly performed the surgery. All authors contributed to the video editing and writing the manuscript. Data availability statement Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.

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