Haemodynamic Response to Aortic Surgery

NCT ID: NCT01704391

Last Updated: 2021-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-05-31

Brief Summary

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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

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Conditions

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Aortic Aneurysm, Abdominal Aortic Diseases Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Aortic aneurysm patients

10 patients with a CT verified diagnosis of aortic aneurysm demanding open elective surgical correction with insertion of vascular prosthesis

No interventions assigned to this group

Aortic occlusive disease patients

10 patients with CT verified aortic occlusive disease demanding open elective surgical correction with insertion of vascular prosthesis

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sygehus Lillebaelt

OTHER

Sponsor Role lead

Responsible Party

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Helene Korvenius Nedergaard

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lillebaelt Hospital, Kolding Hospital

Kolding, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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S-20110154

Identifier Type: -

Identifier Source: org_study_id