Status:
COMPLETED
Argipressin's Influence on Blood Loss During Hepatic Resection
Lead Sponsor:
Kristina Svennerholm
Conditions:
Colon Cancer Liver Metastasis
Inflammatory Response
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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. S...
Detailed Description
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 flo...
Eligibility Criteria
Inclusion
- Participant planned for hepatic resection (open or laparoscopic, regardless of indication for surgery).
- Age ≥18 years.
- ASA class I-III.
- Signed informed consent form
Exclusion
- Participant does not understand the given information, and/ or cannot give written informed consent.
- 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.
- Terminal kidney failure (estimated preoperative GFR\< 15 ml/min)
- Pregnancy or lactation.
- Known allergy to Empressin®.
- Patient included in other interventional study, interacting with the endpoints in the present study, or previous randomization in this study.
- Hyponatremia (S-Na \< 130 mmol/L)
- Patient considered ineligible for other surgical or medical reason.
- 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.
Key Trial Info
Start Date :
March 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2025
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT05293041
Start Date
March 27 2022
End Date
February 17 2025
Last Update
March 6 2025
Active Locations (1)
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1
Sahlgrenska University Hospital
Gothenburg, Sweden, 41345