Skip to main content
OpenTrials
Completed

NCT Number: NCT03878615

Inflammation and Organ Impact During Hepatic Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatic Surgery Hemorrhage Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SahlgrenskaUH

Gothenburg, Västra Götaland County, 41345, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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)

Treatment and study plan

elective surgery, according to deprtement routine

Procedure

none, descriptive study

Primary outcomes

  1. Ischemic Intestinal Damage

    Time frame: from day of surgery until 24-48 hours postoperatively

    rise in IFABP in nanograms/ml,

  2. Kidney injury

    Time frame: from day of surgery and approximately 1 week onwards

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

  3. Intestinal Bacterial Transloction

    Time frame: from day of surgery until 24-48 hours postoperatively

    Rise in D-lactate in micromol/ml

  4. Kidney injury

    Time frame: from day of surgery until 24-48 hours postoperatively

    proenkephaline increase in pico mol/l

  5. Kidney injury

    Time frame: from day of surgery until 24-48 hours postoperatively

    NAG units/g increase in urine.

Secondary outcomes

  1. Description of Inflammatory Response

    Time frame: from day of surgery and approximately 1 week onwards

    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

Other outcomes

  1. blood loss

    Time frame: from day of surgery and approximately 1 week onwards

    need of transfusion

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 18, 2019
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.