Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. Two sub-studies has been added; one for evaluation of coagulation function, and one for assessment of pain scores and morphine consumption.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer Liver Metastasis | — | UNRESOLVED | — |
| Inflammatory Response | — | UNRESOLVED | — |
| Vasopressin Causing Adverse Effects in Therapeutic Use | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Argipressin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Argipressin
- description
- Patients will be treated with Empressin® 0.8 U/ml, 0.056 ml/kg/h during surgery.
- interventionNames
- Drug: Argipressin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients will receive normal saline 0.056 ml/kg/h during surgery.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Blood loss
- timeFrame
- through surgery, an average of 8 hours
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDWisen E, Pivodic A, Skagervik A, Rizell M, Bown LS, Ricksten SE, Svennerholm K. Argipressin for prevention of blood loss in hepatic resection: a randomised, placebo-controlled, double-blind trial. Br J Anaesth. 2026 Apr;136(4):1145-1153. doi: 10.1016/j.bja.2025.09.021. Epub 2025 Oct 30. PMID 41173775
- DERIVEDWisen E, Kvarnstrom A, Sand-Bown L, Rizell M, Pivodic A, Ricksten SE, Svennerholm K. Argipressin for prevention of blood loss during liver resection: a study protocol for a randomised, placebo-controlled, double-blinded trial (ARG-01). BMJ Open. 2023 Aug 24;13(8):e073270. doi: 10.1136/bmjopen-2023-073270. PMID 37620260