Argipressin's Influence on Blood Loss During Hepatic Resection

NCT05293041 | Completed Phase 4

• 1 other identifier: ARG-01
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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. 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

Colon Cancer Liver Metastasis; Inflammatory Response; Vasopressin Causing Adverse Effects in Therapeutic Use

Keywords

hepatic surgery; vasopressin; liver surgery; colon cancer metastasis; transfusion; blood loss; inflammatory response; pain; coagulation

Outcome Measures

Primary Outcomes (1)

• Blood loss

  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.

  through surgery, an average of 8 hours

Secondary Outcomes (16)

• Blood transfusion

  At end of surgery and until postoperative day 2 or 5 respectively

• Inflammatory markers-regular

  Measured throughout the study until postoperative day 2 (laparoscopic resection) or postoperative day 5 (open resection)

• Inflammatory markers- extended

  Measured at throughout the study until postoperative day 2.

• surgical data

  at the end of surgery, approximately 5 hours after start of surgery

• Tranexamic Acid

  at the end of surgery, approximately 5 hours after start of surgery

Other Outcomes (8)

• oral morphine eqivalents

  from day of surgery, postoperative day 1,2 and at discharge from hospital (but no longer than post operative day 5)

• Numeric Rating Scale (NRS)

  Once daily at day of surgery, postoperative day 1 and 2

• Clotting Time (CT)

  before anesthesia, at end of surgery (assessed up to one hour after closing of the abdomen) and postoperative day 1

Study Arms (2)

Argipressin

EXPERIMENTAL

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

Drug: Argipressin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Argipressin DRUG

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.

Also known as: Arg

Argipressin

Placebo DRUG

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.

Also known as: control

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant planned for hepatic resection (open or laparoscopic, regardless of indication for surgery).
• Age ≥18 years.
• ASA class I-III.
• Signed informed consent form

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kristina Svennerholm: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Related Publications (2)

• Wisen 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. 2025 Oct 30:S0007-0912(25)00672-5. doi: 10.1016/j.bja.2025.09.021. Online ahead of print.

  PMID: 41173775 DERIVED

• Wisen 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 DERIVED

MeSH Terms

Conditions

Diabetes Insipidus; Hemorrhage; Pain; Thrombosis

Interventions

Arginine Vasopressin; Arginine

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Amino Acids, Basic; Amino Acids; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• kristina svennerholm, MD PhD

  Senior Consultant Anesthesia and Intensive Care, Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator, MD, PhD

Model Details: Singel center double-blinded, randomized, placebo-controlled trial.

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: March 24, 2022
• Study Start: March 27, 2022
• Primary Completion: December 6, 2024
• Study Completion: February 17, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 months after study closure, and maximum 25 years
• Access Criteria: Confidentiality and ethics assessment.

Locations

SE (1)