Haemodynamic Response to Aortic Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Haemodynamic Response to Aortic Surgery|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||May 2013|
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
- ICU length of stay [ Time Frame: 24 hours postoperatively ]Number of patients with an ICU LOS > 24 hours
- Post-operative need for dialysis [ Time Frame: 72 hours postoperatively ]Number of patients developing dialysis dependency during the first 72 hours postoperatively
- 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
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
|Contact: Helene Joergensen, MD||0045 firstname.lastname@example.org|
|Contact: Jannie Bisgaard, MD||0045 email@example.com|
|Lillebaelt Hospital, Kolding Hospital||Recruiting|
|Kolding, Denmark, DK-6000|
|Contact: Helene Joergensen, MD 0045 53272244|
|Contact: Torben Gilsaa, MD 0045 31430700 firstname.lastname@example.org|
|Principal Investigator: Helene Joergensen, MD|
|Sub-Investigator: Jannie Bisgaard, MD|
|Sub-Investigator: Torben Gilsaa, MD|