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NCT Number: NCT02689414

A Study of Remote Ischaemic Preconditioning in Patients With Atherosclerosis Undergoing Vascular Surgery

The purpose of this study is to evaluate the effect of preoperative remote ischaemic preconditioning (RIPC) on organ damage and the functional characteristics of arteries in patients undergoing vascular surgery. In addition, we investigate the connection between RIPC and changes in the functional characteristics of arteries and low molecular weight metabolites.

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Artery Stenosis Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Peripheral Arterial Disease Peripheral Artery Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tartu University Hospital

Tartu, Tartu County, 50406, Estonia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients who are willing to give full informed consent for participation and
  • who are undergoing open abdominal aortic aneurysm repair or
  • who are undergoing endovascular aortic aneurysm repair or
  • who are undergoing lower limb revascularization surgery or
  • who are undergoing carotid endarterectomy

Exclusion criteria

  • patients under age of 18
  • patients who are pregnant
  • patients with known malignancy during last 5 years
  • patients with permanent atrial fibrillation or flutter
  • patients with symptomatic upper limb atherosclerosis
  • patients who require home oxygen therapy
  • patients with eGFR < 30 ml/min/1.73 m2, measured preoperatively
  • patients who have had myocardial infarction during last month
  • patients who have had upper limb vein thrombosis
  • patients who have undergone vascular surgery in the axillary region
  • patients who are not able to follow the study regimen

Treatment and study plan

Remote ischaemic preconditioning

Procedure

Ischaemia is achieved by using a blood pressure cuff on an arm by raising the cuff pressure to 200 mm Hg or to a value that is 20 mm Hg greater than the patient's systolic blood pressure - if the patient's systolic blood pressure is more than 180 mm Hg. The intervention starts simultaneously with the induction of anaesthesia or a few minutes earlier.

Other names: RIPC

Control to RIPC

Procedure

Venous pressure is achieved by using a blood pressure cuff on an arm by raising the cuff pressure to 10-20 mm Hg. The intervention starts simultaneously with the induction of anaesthesia or a few minutes earlier.

Primary outcomes

  1. Carotide-femoral pulse velocity

    Time frame: 24 h

    Measured with Sphygmocor XCEL

    • baseline characteristics are measured before surgery
    • measuring is repeated 24 h after surgery

  2. Augmentation index

    Time frame: 24 h

    Measured with Sphygmocor XCEL

    • baseline characteristics are measured before surgery
    • measuring is repeated 24 h after surgery

Secondary outcomes

  1. Cardiac markers

    Time frame: 24 h

    Troponin T, Creatine kinase-MB, N-terminal pro-brain natriuretic peptiide (NT-ProBNP).

  2. Traditional biomarkers of renal function

    Time frame: 24 h

    Creatinine, Urea

  3. Markers of inflammation and oxidative stress

    Time frame: 24 h

    Oxidized low-density lipoprotein (oxLDL), Interleukin-18 (IL-18), Myeloperoxidase (MPO), Isoprostane.

  4. Duration of hospital stay

    Time frame: 30 days

  5. Duration of intesive care unit stay

    Time frame: 30 days

  6. Cardiac event

    Time frame: 10 days

    Myocardial infarction or cardiac arrest

  7. Postoperative complications

    Time frame: 10 days

    Surgical wound infection or haematoma, Acute limb ischaemia, Acute deep vein thrombosis, Limb amputation, Pneumonia, Urinary tract infection.

  8. 1- year mortality

    Time frame: 1 year

  9. Complications of remote ishcaemic preconditioning

    Time frame: 10 days

    Upper-extremity deep vein thrombosis, Acute upper limb ischaemia.

  10. Novel biomarkers of renal function

    Time frame: 24 h

    Neutrophil gelatinase-associated lipocalin (NGAL), Liver-type fatty acid binding proteiin (L-FABP), Kidney Injury Molecule-1 (KIM-1), Cystatine C, β2 microglobulin (B2M),

  11. Estimated glomerular filtration rate

    Time frame: 24 h

    eGFR

  12. Low molecular-weight metabolites

    Time frame: 24 h

    • Acylcarnitines
    • Amino acids: leucine, ornithine, methionine, alanine, phenylalanine, valine, glutamate, tyrosine, glycine, arginine, citrulline, asparagine, aspartate, glutamine, histidine, lysine, proline, tryptophan, serine, threonine, cysteine and hydroxyproline.
    • Hydroxy acids: citrate, α-oxoglutarate, pyruvate, succinate, mallonic acid, β-hydroxybutyrate, cis-aconitic acid and oxaloacetate.

  13. Arterial elasticity indices

    Time frame: 24 h

    Measured with HDI pulsewave CR-200

    • baseline characteristics are measured before surgery
    • measuring is repeated 24 h after surgery

Sponsors and collaborators

Lead sponsor

Tartu University Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Feb 24, 2016
Registry last updated
Feb 28, 2018

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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