Haemodynamic Response to Aortic Surgery

Completed

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

• Registration Number: NCT01704391
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-10-04
• Study First Submitted QC: 2012-10-09
• Study First Posted: 2012-10-11
• Primary Completion: 2013-05
• Study Completion: 2015-05
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-15
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ICU length of stay	24 hours postoperatively	Number of patients with an ICU LOS \> 24 hours
Post-operative need for dialysis	72 hours postoperatively	Number of patients developing dialysis dependency during the first 72 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Lillebaelt Hospital, Kolding Hospital; 🇩🇰 Kolding, Denmark