Endothelial Leakage and the Association to Endothelial Biomarkers After Surgery

Endothelial Leakage Assessed by 125-I Labeled Serum Albumin and the Association to Endothelial Biomarkers After Major Abdominal Surgery

The primary aim of this study is to investigate fluid loss from the blood stream (''endothelial leakage'') and the damage on the vessel wall (''endothelial function'') during surgery.

Cardiovascular complications during surgery are said to have different causes, e.g. lack of fluid in the blood stream (''hypovolemia'') and decreased vascular tone. Hypovolemia can have different causes, one being damage to the endothelial function. During trauma and infection, it has been previously shown, that damage to the endothelial function causes fluid loss from the blood stream. Nevertheless, this has never been demonstrated during surgery.

Secondary this study will measure the blood flow using a thermo-camera during surgery. This will together with selected blood tests provide information on various possible causes to hypovolemia.

The purpose of this study is to describe and quantify endothelial damage (assessed by selected endothelial biomarkers) and albumin escape rate as a proxy for endothelial leakage (assessed by measuring radioactive 125-I labeled HSA injected postoperatively), combined with assessment of MTS (assessed by Laser Speckle Contrast Imaging (LSCI) and digital thermography). This will allow a detailed description of the surgery's impact on the endothelial integrity and contribute to a better understanding of the physiological changes that occur postoperatively.

The study will investigate patients undergoing pancreaticoduodenectomy (Whipple) and total pancreatectomy. These patients have a vast clinical need, being one of the most extensive abdominal surgical procedures with great stress response.

The study is a prospective exploratory cohort study and methods include blood sampling pre- and post-operatively, 125-I labeled humane serum albumin postoperatively (and preoperatively if logistically possible) and thermography.

The hypothesis of this study is that the extent of endothelial damage measured by selected biomarkers is associated with the level of albumin escape rate after major abdominal surgery. Secondly, inflammation increases albumin escape rate after major abdominal surgery.

Study Overview

• Status: Completed
• Conditions: Pancreas Disease

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Major abdominal surgery patients will be included. Patients are screened prior to surgery from electronic medical charts. Patients can be co-enrolled in other non-intervention trials. An outline of scheduled study activities is shown in figure one.

Description

Inclusion Criteria:

• Age ≥ 18 years
• Patients are scheduled for Whipple or total pancreatectomy

Exclusion Criteria:

• Patient having received immunomodulating treatments less than four weeks prior to surgery
• Patient having other major surgery performed less than four weeks prior to surgery. Thus, minor surgery allowed, for instance minor skin incisions
• Patient having endoscopic retrograde cholangiopancreatography (ERCP) or Percutaneous transhepatic cholangiography (PTC) performed less than two weeks prior to surgery
• Patients scheduled for major vascular surgery during Whipple or total pancreatectomy
• Patient is diagnosed with chronic kidney failure or is in diuretics treatment

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Albumin escape rate during the first five postoperative days assessed by intravascular loss of 125-I labeled HSA.	Measured by the use of iod tracer	five days after surgery

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases
• Other Study ID Numbers: 2022-RH-iod-tracer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data for all included patients will be available for other selected research colleagues
• IPD Sharing Time Frame: Up to 5 years after data collected
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No