Haemodynamic Response to Aortic Surgery

Open elective abdominal aortic surgery is a high risk procedure involving clamping of the aorta. Indications include abdominal aortic aneurysm (AAA) or aortic occlusive disease (AOD) causing lower limb ischaemia.

These patients are often regarded as one entity in postoperative study settings. However, previous studies indicate that risk profiles, inflammatory activity, and haemodynamic capacity may differ between these groups. The first aim of this study was to evaluate postoperative ICU-requirements after open elective abdominal aortic surgery, hypothesising that AAA-patients had longer ICU-stays and needed more mechanical ventilation or acute dialysis than did patients with AOD.

The investigators see a relatively high incidence of postoperative acute kidney injury (AKI) following aortic surgery. Neutrophil Gelatinase Associated Lipocalcin (NGAL) may be useful in the early diagnosis of postopeative AKI. However, NGAL is also known as a marker of inflammatory activation. The ischaemia-reperfusion injury and subsequent inflammatory response to aortic cross clamping may per se induce a rise in NGAL despite intact renal function. Therefore NGAL may not be a reliable marker of AKI after AAS.

The second aim of this study is to describe the changes in NGAL after AAS in patients with and without postoperative dialysis-dependent AKI.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Aortic Aneurysm, Abdominal; Aortic Diseases

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Denmark
  • Kolding, Denmark, DK-6000
    • Lillebaelt Hospital, Kolding Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

10 patients sceduled for elective open operation for aortic aneurysm disease and 10 patients sceduled for elective open operation for aortic occlusive disease

Description

Inclusion Criteria:

• CT verified aortic aneurysm or aortic occlusive disease

Exclusion Criteria:

• age<18 y
• contraindications to the use of oesophagus doppler monitor, eg mycosis, perforation, stenosis.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Aortic aneurysm patients; 10 patients with a CT verified diagnosis of aortic aneurysm demanding open elective surgical correction with insertion of vascular prosthesis
Aortic occlusive disease patients; 10 patients with CT verified aortic occlusive disease demanding open elective surgical correction with insertion of vascular prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU length of stay	Number of patients with an ICU LOS > 24 hours	24 hours postoperatively
Post-operative need for dialysis	Number of patients developing dialysis dependency during the first 72 hours postoperatively	72 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic peroperative changes in AAD vs AOD	Stroke volume, cardiac index, systemic vasular resistance is recorded for AAD- and AOD patients at five time points during the operation using CardioQ, an oesophagus doppler monitor.	After anaesthesia induction, 10 minutes after aortic cross-clamping, 10 minutes after reperfusion, end of surgery

Collaborators and Investigators

• Sponsor: Sygehus Lillebaelt

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: October 4, 2012
• First Submitted That Met QC Criteria: October 9, 2012
• First Posted (Estimate): October 11, 2012

Study Record Updates

• Last Update Posted (Actual): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Diseases
• Other Study ID Numbers: S-20110154

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No