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Colon Cancer Liver MetastasisPhase 4ARG-01NCT05293041

Argipressin's Influence on Blood Loss During Hepatic Resection

A Phase 4 study testing Argipressin in people with Colon Cancer Liver Metastasis and Inflammatory Response, run by Kristina Svennerholm at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Argipressin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
248 participants
Where
1 siteSweden
Study dates
27 Mar 2022to 17 Feb 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Sahlgrenska University Hospital

    Gothenburg, 41345

Other trials in Sweden

About this study

Official title: Influence of Argipressin on Blood Loss During Hepatic Resection; a Double-blinded, Randomized Placebo-controlled Trial (ARG-01)

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.

Read the 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 flow to the liver can be influenced by pharmacological means, blood loss and transfusion requirements may be reduced. Moreover, the inflammatory system is involved in cancer development, and the anti-inflammatory properties of Argipressin may decrease the inflammatory response after hepatic surgery.

Argipressin is an endogenous substance, and part of the body's response to stress and trauma. Argipressin affects V1-receptors to produce vasoconstriction. It is also involved in inflammatory reactions and affects platelets.

Patients will be stratified according to planned type of surgery (open/laparoscopic) and planned extent of resection, and randomized to etiher infusion of Argipressin or placebo (normal saline) during surgery. In all other aspects, the participants will be treated according to the institution protocol for hepatic resection. The study drug will be started as soon as the central line is placed, and discontinued at the end of surgery. Hemodynamic data will be collected during surgery, and blood and urine-samples will be obtained during and after surgery for analysis of inflammatory markers and markers of organ injury.

Being tested
Argipressin, Placebo
Keywords
hepatic surgery, vasopressin, liver surgery, colon cancer metastasis, transfusion, blood loss, inflammatory response, pain, coagulation
Medical subject headings
Diabetes Insipidus, Hemorrhage, Pain, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ArgipressinDrug

    Also called Arg

    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.

  • PlaceboDrug

    Also called control

    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.

Study groups in NCT05293041
Study groupRoleWhat they receive
ArgipressinExperimentalPatients will be treated with Empressin® 0.8 U/ml, 0.056 ml/kg/h during surgery.
Receives: Drug: Argipressin
PlaceboPlacebo comparatorPatients will receive normal saline 0.056 ml/kg/h during surgery.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: through surgery, an average of 8 hours

Secondary outcomes (16)

  1. Blood transfusion

    Blood transfusion (ml) at the end of surgery and at postoperative day 1 and 2 and 5 respectively.

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

  2. Inflammatory markers-regular

    Levels of White Blood Cell count, C Reactive Protein, Platelet count and Albumin at the end of surgery and postoperative day 1-5

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

  3. Inflammatory markers- extended

    Levels of Interleukin (IL)-1 Beta, IL-6, IL-8, IL-10, Monocyte chemoattractant protein-1, Stromal Cell-Derived Factor-1 alpha, Intercellular Adhesion Molecule, Complement (C) 3a, C5b-9 at the end of surgery and postoperative day 1 and 2.

    Measured: Measured at throughout the study until postoperative day 2.

  4. surgical data

    duration of Pringles manouvre (min), duration of resection phase (min) and surgery (min)

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

  5. Tranexamic Acid

    use of tranexamic acid (mg)

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

  6. CVP (anesthesiological data)

    achievement of CVP (central venous pressure) goal (mmHg), as recorded on the Phillips monitor.

    Measured: during surgery

  7. Noradrenaline use (anesthesiologigal data)

    Total use of noradrenaline (micrograms/minutes of surgery/ bodyweight)

    Measured: during surgery

  8. use of diuretics

    Furosemide use (mg)

    Measured: until postoperative day 1

  9. urine output

    urine output (ml)

    Measured: until postoperative day 1

  10. postoperative complications

    Postoperative complications including death and radicality of resection at 30-day follow up.

    Measured: 30 days after surgery

  11. Length of stay

    Length of stay in hospital

    Measured: From admission in hospital to discharge, expected time 2-5 days but will be followed until actual discharge, which may be several months.

  12. Plasma Creatinine (change in organ damage markers)

    Change in plasma creatinine (micro-mole/L)

    Measured: from baseline (before surgery) to postoperative day 2 and 5 respectively.

  13. Urine samples (change in organ damage markers)

    Change in urine creatinine and urine [TIMP-2] x [IGFBP-7] (quota, no unit)

    Measured: from baseline to end of surgery, approximately 5 hours

  14. Cardiac marker (change in organ damage markers)

    Change in hs- TNI (ng/L)

    Measured: from baseline to postoperative day 1

  15. Lactate (change in organ damage markers)

    change in plasma lactate

    Measured: from baseline to postoperative day 1

  16. I-FABP (change in organ damage markers)

    Change in I-FABP (ng/L)

    Measured: from baseline to postoperative day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2022
  2. Study start27 Mar 2022
  3. Primary completion6 Dec 2024
  4. Study completion17 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Singel center double-blinded, randomized, placebo-controlled trial.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05293041
Sponsor's protocol ID
ARG-01
Acronym
ARG-01
Status last verified
Mar 2025
First submitted
15 Nov 2021
Last updated
6 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Metadata will be shared by the Swedish National Data Service (SND, https://snd.gu.se/en) and selected psedonymised data will be made available on reasonable request, after proper confidentiality and ethics assessment. The extent of data made available will be decided after study closure, and also the time span for availability.

Publications

  • 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. 2026 Apr;136(4):1145-1153. doi: 10.1016/j.bja.2025.09.021. Epub 2025 Oct 30.

    PubMed 41173775

  • 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.

    PubMed 37620260

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Argipressin in people with Colon Cancer Liver Metastasis and Inflammatory Response, run by Kristina Svennerholm at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood loss (time frame: through surgery, an average of 8 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05293041, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.

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