Haemodynamic Response to Aortic Surgery

Acute Kidney Injury Clinical Trial

Official title:

Haemodynamic Response to Aortic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01704391
• Other study ID #: S-20110154
• Status: Completed
• Start date: January 2012
• Est. completion date: May 2015

Study information

• Verified date: October 2021
• Source: Sygehus Lillebaelt
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2015
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Diseases

Locations

Country	Name	City	State
Denmark	Lillebaelt Hospital, Kolding Hospital	Kolding

Sponsors (1)

Lead Sponsor	Collaborator
Sygehus Lillebaelt

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU length of stay	Number of patients with an ICU LOS > 24 hours	24 hours postoperatively
Primary	Post-operative need for dialysis	Number of patients developing dialysis dependency during the first 72 hours postoperatively	72 hours postoperatively
Secondary	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