Haemodynamic Response to Aortic Surgery

Sygehus Lillebaelt (Other)
Overall Status
CT.gov ID

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Actual Enrollment :
    18 participants
    Observational Model:
    Time Perspective:
    Official Title:
    Haemodynamic Response to Aortic Surgery
    Study Start Date :
    Jan 1, 2012
    Actual Primary Completion Date :
    May 1, 2013
    Actual Study Completion Date :
    May 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. ICU length of stay [24 hours postoperatively]

      Number of patients with an ICU LOS > 24 hours

    2. Post-operative need for dialysis [72 hours postoperatively]

      Number of patients developing dialysis dependency during the first 72 hours postoperatively

    Secondary Outcome Measures

    1. Hemodynamic peroperative changes in AAD vs AOD [After anaesthesia induction, 10 minutes after aortic cross-clamping, 10 minutes after reperfusion, end of surgery]

      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.

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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.

    Contacts and Locations


    Site City State Country Postal Code
    1 Lillebaelt Hospital, Kolding Hospital Kolding Denmark DK-6000

    Sponsors and Collaborators

    • Sygehus Lillebaelt


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Helene Korvenius Nedergaard, MD, Sygehus Lillebaelt
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • S-20110154
    First Posted:
    Oct 11, 2012
    Last Update Posted:
    Oct 18, 2021
    Last Verified:
    Oct 1, 2021

    Study Results

    No Results Posted as of Oct 18, 2021