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Haemodynamic Response to Aortic Surgery

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ClinicalTrials.gov Identifier: NCT01704391
Recruitment Status : Unknown
Verified October 2012 by Helene K. Joergensen, Sygehus Lillebaelt.
Recruitment status was:  Recruiting
First Posted : October 11, 2012
Last Update Posted : October 11, 2012
Sponsor:
Information provided by (Responsible Party):
Helene K. Joergensen, Sygehus Lillebaelt

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
Aortic Aneurysm, Abdominal Aortic Diseases Acute Kidney Injury

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Haemodynamic Response to Aortic Surgery
Study Start Date : January 2012
Estimated Primary Completion Date : May 2013

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. ICU length of stay [ Time Frame: 24 hours postoperatively ]
    Number of patients with an ICU LOS > 24 hours

  2. Post-operative need for dialysis [ Time Frame: 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 [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
Urine samples taken from urinary catheter. Centrifuged, supernatant frozen at -80 degrees C. Immunoassay analyzed at Roche modular P quantifying NGAL.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704391


Contacts
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Contact: Helene Joergensen, MD 0045 53272244 helene_j@yahoo.com
Contact: Jannie Bisgaard, MD 0045 60630890 janniebisgaard@hotmail.com

Locations
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Denmark
Lillebaelt Hospital, Kolding Hospital Recruiting
Kolding, Denmark, DK-6000
Contact: Helene Joergensen, MD    0045 53272244      
Contact: Torben Gilsaa, MD    0045 31430700    torbengilsaa@hotmail.com   
Principal Investigator: Helene Joergensen, MD         
Sub-Investigator: Jannie Bisgaard, MD         
Sub-Investigator: Torben Gilsaa, MD         
Sponsors and Collaborators
Sygehus Lillebaelt

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Responsible Party: Helene K. Joergensen, MD, Sygehus Lillebaelt
ClinicalTrials.gov Identifier: NCT01704391     History of Changes
Other Study ID Numbers: S-20110154
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Acute Kidney Injury
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aortic Diseases
Vascular Diseases
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases