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Clinical Trials/NCT01704391
NCT01704391
Completed
Not Applicable

Haemodynamic Response to Aortic Surgery

Sygehus Lillebaelt1 site in 1 country18 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Aneurysm, Abdominal
Sponsor
Sygehus Lillebaelt
Enrollment
18
Locations
1
Primary Endpoint
ICU length of stay
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
May 2015
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sygehus Lillebaelt
Responsible Party
Principal Investigator
Principal Investigator

Helene Korvenius Nedergaard

MD

Sygehus Lillebaelt

Eligibility 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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Hemodynamic peroperative changes in AAD vs AOD(After anaesthesia induction, 10 minutes after aortic cross-clamping, 10 minutes after reperfusion, end of surgery)

Study Sites (1)

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