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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02689414
Recruitment Status : Completed
First Posted : February 24, 2016
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Jaak Kals, Tartu University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Peripheral Artery Disease Carotid Artery Stenosis Procedure: Remote ischaemic preconditioning Procedure: Control to RIPC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: Patient, patient's physician, surgeon, anaesthesiologist and everyone else in the surgical team were blinded to study intervention. Blinding was attained with manometer's scale covered. Second arterial stiffness measurement was carried out by a study member who did not know the patient's group affiliation.
Primary Purpose: Prevention
Study Start Date : January 2016
Actual Primary Completion Date : February 8, 2018
Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arm Intervention/treatment
Experimental: Remote ischaemic preconditioning
Four episodes of 5 minutes of ischaemia are performed. Between all the episodes there is a 5-minute period of reperfusion.
Procedure: Remote ischaemic preconditioning
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 Name: RIPC

Sham Comparator: Control to RIPC
Four episodes of 5 minutes during which the pressure in the cuff is equal to venous pressure are performed. Between all the episodes there is a 5-minute pause.
Procedure: Control to RIPC
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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689414


Locations
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Estonia
Tartu University Hospital
Tartu, Tartu County, Estonia, 50406
Sponsors and Collaborators
Tartu University Hospital
Investigators
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Study Chair: Urmas Lepner, MD-PhD Tartu University Hospital
Study Chair: Joel Starkopf, MD-PhD Tartu University Hospital
Study Chair: Mihkel Zilmer, MD-PhD University of Tartu
Principal Investigator: Jaak Kals, MD-PhD Tartu University Hospital
Study Chair: Karl Kuusik, MD University of Tartu
Study Director: Teele Kepler, MD University of Tartu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jaak Kals, Clinic of Surgery, Department of Vascular Surgery, cardiovascular surgeon; MD-PhD, Tartu University Hospital
ClinicalTrials.gov Identifier: NCT02689414    
Other Study ID Numbers: 16004
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Keywords provided by Jaak Kals, Tartu University Hospital:
Atherosclerosis
Additional relevant MeSH terms:
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Carotid Stenosis
Aneurysm
Atherosclerosis
Aortic Aneurysm
Peripheral Arterial Disease
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Aortic Diseases
Peripheral Vascular Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases