Hepatic resection due to primary malignant disease, metastasis or benign tumour MedDRA version: 21.0 Level: LLT Classification code 10019701 Term: Hepatic neoplasm malignant resectable System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Empressin®
Product Name: Argipressin (vasopressin)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Argipressin
CAS Number: 113-79-1
Concentration unit: U/ml
Sponsors
Sahlgrenska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 124 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 124
Exclusion criteria
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 (extended testing) where cytokines and interleukins are investigated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if infusion of Argipressin during hepatic resection surgery reduces blood loss compared to placebo;Secondary Objective: •To determine if infusion of Argipressin during hepatic resection surgery reduces the need of transfusions during and after surgery, compared to placebo. •To determine if infusion of Argipressin during hepatic resection surgery mitigates the postoperative inflammatory response, compared to placebo. ;Primary end point(s): Blood loss (ml) at the end of surgery, measured according to the investigator’s instructions, by visual assessment of suction devices and gauze, and subtraction of ascites and irrigation fluids;Timepoint(s) of evaluation of this end point: At completion of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Blood transfusion (ml) at the end of surgery and at postoperative day 1. •Levels of WBC, CRP, PLT and Albumin at the end of surgery and postoperative day 1-5. •Levels of IL-1beta IL-6, IL-8, IL-10, MCP-1, SDF-1alfa, ICAM, C3a, C5b-9 at the end of surgery and postoperative day 1 and 2. To evaluate effects of the study drug on kidneys, heart and intestines, tissue biomarkers will be part of the study protocol: •Plasma creatinine will be controlled at postoperative day 1, 2 and 5. Urine NAG, urine creatinine and urine [TIMP-2] x [IGFBP-7] will be controlled after surgery. •Hs-TNI will be controlled at the end of surgery and at postoperative day 1. •Arterial lactate will be controlled at the end of surgery, at three hours after surgery and at postoperative day 1. •IFABP will be controlled at three hours after surgery and postoperative day one. Perioperative data and hemodynamic measurements as listed below will be recorded and presented as descriptive data. •Vasopressor use during surgery, achievement of CVP goal, total urine output and use of furosemide at postoperative day 1. •Measurements of mean arterial blood pressure (MAP), heart rate, CVP and Cardiac Index (if applicable), as well as assessment of capillary refill time in digits at the end of surgery. •Total time of surgical hepatic occlusion and radicality of resection. •Clinical Frailty Scale (CFS) at inclusion, length of stay in hospital, and postoperative complications documented at postoperative day 30 ;Timepoint(s) of evaluation of this end point: End of surgery and day 1-5 | — |
Countries
Sweden
Contacts
Public ContactAnOpIVA
Sahlgrenska Universitetssjukhuset/Sahlgrenska
Outcome results
None listed