Endothelial Leakage and the Association to Endothelial Biomarkers After Surgery

NCT05333991 | Completed

• 1 other identifier: 2022-RH-iod-tracer
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreas Disease

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma is collected from blood samples

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: August 31, 2022
• Primary Completion: August 1, 2023
• Study Completion: November 1, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Up to 5 years after data collected

Locations

DK (1)