Inflammation and Organ Impact During Hepatic Surgery

NCT ID: NCT03878615

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-10

Study Completion Date

2019-04-02

Brief Summary

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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

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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

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Hepatic Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Elective Hepatic Surgery

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

elective surgery, according to deprtement routine

Intervention Type PROCEDURE

none, descriptive study

Interventions

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elective surgery, according to deprtement routine

none, descriptive study

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ellinor Wisén

MD, consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sven-Erik Ricksten, MD, PhD, professor

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

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SahlgrenskaUH

Gothenburg, Västra Götaland County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Dnr740-18

Identifier Type: -

Identifier Source: org_study_id

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