Inflammation and Organ Impact During Hepatic Surgery

Hepatic Surgery Clinical Trial

Official title:

Inflammation and Organ Impact During Hepatic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03878615
• Other study ID #: Dnr740-18
• Status: Completed
• Start date: November 10, 2018
• Est. completion date: April 2, 2019

Study information

• Verified date: April 2019
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2, 2019
• Est. primary completion date: April 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hepatic Surgery
• Inflammation

Intervention

Procedure:
• elective surgery, according to deprtement routine
none, descriptive study

Locations

Country	Name	City	State
Sweden	SahlgrenskaUH	Gothenburg	Västra Götaland

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	blood loss	need of transfusion	from day of surgery and approximately 1 week onwards
Primary	Ischemic Intestinal Damage	rise in IFABP in nanograms/ml,	from day of surgery until 24-48 hours postoperatively
Primary	Kidney injury	as described by KDIGO (Kidney Disease Improving Global Outcomes) criteria	from day of surgery and approximately 1 week onwards
Primary	Intestinal Bacterial Transloction	Rise in D-lactate in micromol/ml	from day of surgery until 24-48 hours postoperatively
Primary	Kidney injury	proenkephaline increase in pico mol/l	from day of surgery until 24-48 hours postoperatively
Primary	Kidney injury	NAG units/g increase in urine.	from day of surgery until 24-48 hours postoperatively
Secondary	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	from day of surgery and approximately 1 week onwards