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OpenTrials
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NCT Number: NCT01704391

Haemodynamic Response to Aortic Surgery

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.

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Key information

Conditions

Aortic Aneurysm, Abdominal Acute Kidney Injury Aneurysm Aortic Aneurysm Aortic Diseases Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lillebaelt Hospital, Kolding Hospital

Kolding, DK-6000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. ICU length of stay

    Time frame: 24 hours postoperatively

    Number of patients with an ICU LOS > 24 hours

  2. Post-operative need for dialysis

    Time frame: 72 hours postoperatively

    Number of patients developing dialysis dependency during the first 72 hours postoperatively

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sygehus Lillebaelt

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Oct 11, 2012
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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