Hepatic SurgeryNCT03878615
Inflammation and Organ Impact During Hepatic Surgery
An observational study of Hepatic Surgery, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Monitoring of inflammatory substances (such as interleukins, CRP, albumine), and markers of organ dysfunction (such as creatinine, proenkephaline, amylase, troponine, IFABP and lactate) during elective liver resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Surgery
- What is being tested?
- elective surgery, according to deprtement routine
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteSweden
- Study dates
- 10 Nov 2018to 2 Apr 2019
- Phase
- Observational
- 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
Study population: patients scheduled for open liver resection, ASA class I-III.
Who may be able to join
- ASA I-III Patient has given informed consent to participate in study.
Who cannot join
- preoperative kidney failure (E-GFR >30), current infection treatment with corticosteroids coagulopathy surgical or anatomical conditions that makes patient unsuitable for participation (for example reoperation, need of vascular bypass, single tumor)
Trial locations and contacts
1 site in 1 country.
About this study
Monitoring of inflammatory substances (such as interleukins, CRP, albumine), and markers of organ dysfunction (such as creatinine, proenkephaline, amylase, troponine, IFABP and lactate) during elective liver resection. The study also includes monitoring of hemodynamic parameters, blood loss and postoperative complications. Results are to be used för power calculation for future trials.
Read the detailed description
During hepatic surgery, blood and urine samples will be obtained at 3 times during surgery, at 3 h after resection of liver, at 24 h after resection of liver and at post operative day 2, and subsequntly analyzed for the above mentioned substances. Routine labs will be monitored until patient is discharged from hospital. During surgery, hemodynamic parameters will be monitored by Picco calculations. Urine output and blood loss will be registred.
- Conditions
- Hepatic Surgery
- Being tested
- elective surgery, according to deprtement routine
- Keywords
- liver surgery, hepatic resection, inflammation, organ dysfunction, blood loss, IFABP
- Medical subject headings
- Inflammation, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elective surgery, according to deprtement routineProcedure or surgery
none, descriptive study
| Study group | Role | What they receive |
|---|---|---|
| Elective Hepatic Surgery | Patientes undergoing elective hepatic resection, managed according to departement routine. Receives: Procedure: elective surgery, according to deprtement routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic Intestinal Damage
rise in IFABP in nanograms/ml,
Measured: from day of surgery until 24-48 hours postoperatively
Kidney injury
as described by KDIGO (Kidney Disease Improving Global Outcomes) criteria
Measured: from day of surgery and approximately 1 week onwards
Intestinal Bacterial Transloction
Rise in D-lactate in micromol/ml
Measured: from day of surgery until 24-48 hours postoperatively
Kidney injury
proenkephaline increase in pico mol/l
Measured: from day of surgery until 24-48 hours postoperatively
Kidney injury
NAG units/g increase in urine.
Measured: from day of surgery until 24-48 hours postoperatively
Secondary outcomes (1)
Description of Inflammatory Response
Changes in MCP-1, SDF-1, IL-1beta, TNF-alfa, IL-6, IL-8, IL-10 and HMBG-1, in blood samples obtained during and after heptaic surgery
Measured: from day of surgery and approximately 1 week onwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start10 Nov 2018
- Primary completion2 Apr 2019
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic SurgeryStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellinor Wisén, Sahlgrenska University Hospital
- Investigators
- Sven-Erik Ricksten, MD, PhD, professor, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878615
- Sponsor's protocol ID
- Dnr740-18
- Status last verified
- Apr 2025
- First submitted
- 6 Nov 2018
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation and Organ Impact During Hepatic Surgery
- ClinicalTrials.gov ID
- NCT03878615
- Acronym / sponsor ID
- Dnr740-18
- Conditions
- Hepatic Surgery
- Keywords
- liver surgery, hepatic resection, inflammation, organ dysfunction, blood loss, IFABP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Monitoring of inflammatory substances (such as interleukins, CRP, albumine), and markers of organ dysfunction (such as creatinine, proenkephaline, amylase, troponine, IFABP and lactate) during elective liver resection. The study also includes monitoring of hemodynamic parameters, blood loss and postoperative complications. Results are to be used för power calculation for future trials.
Detailed description
During hepatic surgery, blood and urine samples will be obtained at 3 times during surgery, at 3 h after resection of liver, at 24 h after resection of liver and at post operative day 2, and subsequntly analyzed for the above mentioned substances. Routine labs will be monitored until patient is discharged from hospital. During surgery, hemodynamic parameters will be monitored by Picco calculations. Urine output and blood loss will be registred.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective Hepatic Surgery | – | Procedure: elective surgery, according to deprtement routinePatientes undergoing elective hepatic resection, managed according to departement routine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for open liver resection, ASA class I-III.
Key inclusion criteria (1 listed)
- ASA I-III Patient has given informed consent to participate in study.
Key exclusion criteria (1 listed)
- preoperative kidney failure (E-GFR >30), current infection treatment with corticosteroids coagulopathy surgical or anatomical conditions that makes patient unsuitable for participation (for example reoperation, need of vascular bypass, single tumor)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elective surgery, according to deprtement routinenone, descriptive study | Procedure or surgery | Elective Hepatic Surgery |
Primary outcome
Ischemic Intestinal Damage
Time frame: from day of surgery until 24-48 hours postoperatively
rise in IFABP in nanograms/ml,
Kidney injury
Time frame: from day of surgery and approximately 1 week onwards
as described by KDIGO (Kidney Disease Improving Global Outcomes) criteria
Intestinal Bacterial Transloction
Time frame: from day of surgery until 24-48 hours postoperatively
Rise in D-lactate in micromol/ml
Kidney injury
Time frame: from day of surgery until 24-48 hours postoperatively
proenkephaline increase in pico mol/l
Kidney injury
Time frame: from day of surgery until 24-48 hours postoperatively
NAG units/g increase in urine.
1 secondary outcome
Description of Inflammatory Response
Time frame: from day of surgery and approximately 1 week onwards
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven-Erik Ricksten, MD, PhD, professor principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Surgery, run by Sahlgrenska University Hospital 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 1 inclusion and 1 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 27 Apr 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Ischemic Intestinal Damage (time frame: from day of surgery until 24-48 hours postoperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2025.