Inflammation and Organ Impact During Hepatic Surgery

NCT03878615 | Completed

• 1 other identifier: Dnr740-18
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. The study also includes monitoring of hemodynamic parameters, blood loss and postoperative complications. Results are to be used för power calculation for future trials.

Conditions

Hepatic Surgery

Keywords

liver surgery; hepatic resection; inflammation; organ dysfunction; blood loss; IFABP

Outcome Measures

Primary Outcomes (5)

• Ischemic Intestinal Damage

  rise in IFABP in nanograms/ml,

  from day of surgery until 24-48 hours postoperatively

• Kidney injury

  as described by KDIGO (Kidney Disease Improving Global Outcomes) criteria

  from day of surgery and approximately 1 week onwards

• Intestinal Bacterial Transloction

  Rise in D-lactate in micromol/ml

  from day of surgery until 24-48 hours postoperatively

• Kidney injury

  proenkephaline increase in pico mol/l

  from day of surgery until 24-48 hours postoperatively

• Kidney injury

  NAG units/g increase in urine.

  from day of surgery until 24-48 hours postoperatively

Secondary Outcomes (1)

• Description of Inflammatory Response

  from day of surgery and approximately 1 week onwards

Other Outcomes (1)

• blood loss

  from day of surgery and approximately 1 week onwards

Study Arms (1)

Elective Hepatic Surgery

Patientes undergoing elective hepatic resection, managed according to departement routine.

Procedure: elective surgery, according to deprtement routine

Interventions

elective surgery, according to deprtement routine PROCEDURE

none, descriptive study

Elective Hepatic Surgery

Eligibility Criteria

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

Study Population

patients scheduled for open liver resection, ASA class I-III.

You may qualify if:

• ASA I-III Patient has given informed consent to participate in study.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

SahlgrenskaUH

Gothenburg, Västra Götaland County, 41345, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum and urinary samples

MeSH Terms

Conditions

Inflammation; Hemorrhage

Interventions

Elective Surgical Procedures

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Sven-Erik Ricksten, MD, PhD, professor

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, consultant

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: March 18, 2019
• Study Start: November 10, 2018
• Primary Completion: April 2, 2019
• Study Completion: April 2, 2019
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)