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

Primary Purpose

Abdominal Aortic Aneurysm, Peripheral Artery Disease, Carotid Artery Stenosis

Status
Completed
Phase
Not Applicable
Locations
Estonia
Study Type
Interventional
Intervention
Remote ischaemic preconditioning
Control to RIPC
Sponsored by
Tartu University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Abdominal Aortic Aneurysm focused on measuring Atherosclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tartu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Remote ischaemic preconditioning

Control to RIPC

Arm Description

Four episodes of 5 minutes of ischaemia are performed. Between all the episodes there is a 5-minute period of reperfusion.

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.

Outcomes

Primary Outcome Measures

Carotide-femoral pulse velocity
Measured with Sphygmocor XCEL baseline characteristics are measured before surgery measuring is repeated 24 h after surgery
Augmentation index
Measured with Sphygmocor XCEL baseline characteristics are measured before surgery measuring is repeated 24 h after surgery

Secondary Outcome Measures

Cardiac markers
Troponin T, Creatine kinase-MB, N-terminal pro-brain natriuretic peptiide (NT-ProBNP).
Traditional biomarkers of renal function
Creatinine, Urea
Markers of inflammation and oxidative stress
Oxidized low-density lipoprotein (oxLDL), Interleukin-18 (IL-18), Myeloperoxidase (MPO), Isoprostane.
Duration of hospital stay
Duration of intesive care unit stay
Cardiac event
Myocardial infarction or cardiac arrest
Postoperative complications
Surgical wound infection or haematoma, Acute limb ischaemia, Acute deep vein thrombosis, Limb amputation, Pneumonia, Urinary tract infection.
1- year mortality
Complications of remote ishcaemic preconditioning
Upper-extremity deep vein thrombosis, Acute upper limb ischaemia.
Novel biomarkers of renal function
Neutrophil gelatinase-associated lipocalin (NGAL), Liver-type fatty acid binding proteiin (L-FABP), Kidney Injury Molecule-1 (KIM-1), Cystatine C, β2 microglobulin (B2M),
Estimated glomerular filtration rate
eGFR
Low molecular-weight metabolites
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.
Arterial elasticity indices
Measured with HDI pulsewave CR-200 baseline characteristics are measured before surgery measuring is repeated 24 h after surgery

Full Information

First Posted
February 3, 2016
Last Updated
February 26, 2018
Sponsor
Tartu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02689414
Brief Title
A Study of Remote Ischaemic Preconditioning in Patients With Atherosclerosis Undergoing Vascular Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
February 8, 2018 (Actual)
Study Completion Date
February 2019 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tartu University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm, Peripheral Artery Disease, Carotid Artery Stenosis
Keywords
Atherosclerosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare 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.
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote ischaemic preconditioning
Arm Type
Experimental
Arm Description
Four episodes of 5 minutes of ischaemia are performed. Between all the episodes there is a 5-minute period of reperfusion.
Arm Title
Control to RIPC
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Remote ischaemic preconditioning
Other Intervention Name(s)
RIPC
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Control to RIPC
Intervention Description
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 Measure Information:
Title
Carotide-femoral pulse velocity
Description
Measured with Sphygmocor XCEL baseline characteristics are measured before surgery measuring is repeated 24 h after surgery
Time Frame
24 h
Title
Augmentation index
Description
Measured with Sphygmocor XCEL baseline characteristics are measured before surgery measuring is repeated 24 h after surgery
Time Frame
24 h
Secondary Outcome Measure Information:
Title
Cardiac markers
Description
Troponin T, Creatine kinase-MB, N-terminal pro-brain natriuretic peptiide (NT-ProBNP).
Time Frame
24 h
Title
Traditional biomarkers of renal function
Description
Creatinine, Urea
Time Frame
24 h
Title
Markers of inflammation and oxidative stress
Description
Oxidized low-density lipoprotein (oxLDL), Interleukin-18 (IL-18), Myeloperoxidase (MPO), Isoprostane.
Time Frame
24 h
Title
Duration of hospital stay
Time Frame
30 days
Title
Duration of intesive care unit stay
Time Frame
30 days
Title
Cardiac event
Description
Myocardial infarction or cardiac arrest
Time Frame
10 days
Title
Postoperative complications
Description
Surgical wound infection or haematoma, Acute limb ischaemia, Acute deep vein thrombosis, Limb amputation, Pneumonia, Urinary tract infection.
Time Frame
10 days
Title
1- year mortality
Time Frame
1 year
Title
Complications of remote ishcaemic preconditioning
Description
Upper-extremity deep vein thrombosis, Acute upper limb ischaemia.
Time Frame
10 days
Title
Novel biomarkers of renal function
Description
Neutrophil gelatinase-associated lipocalin (NGAL), Liver-type fatty acid binding proteiin (L-FABP), Kidney Injury Molecule-1 (KIM-1), Cystatine C, β2 microglobulin (B2M),
Time Frame
24 h
Title
Estimated glomerular filtration rate
Description
eGFR
Time Frame
24 h
Title
Low molecular-weight metabolites
Description
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.
Time Frame
24 h
Title
Arterial elasticity indices
Description
Measured with HDI pulsewave CR-200 baseline characteristics are measured before surgery measuring is repeated 24 h after surgery
Time Frame
24 h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urmas Lepner, MD-PhD
Organizational Affiliation
Tartu University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Joel Starkopf, MD-PhD
Organizational Affiliation
Tartu University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mihkel Zilmer, MD-PhD
Organizational Affiliation
University of Tartu
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jaak Kals, MD-PhD
Organizational Affiliation
Tartu University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karl Kuusik, MD
Organizational Affiliation
University of Tartu
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Teele Kepler, MD
Organizational Affiliation
University of Tartu
Official's Role
Study Director
Facility Information:
Facility Name
Tartu University Hospital
City
Tartu
State/Province
Tartu County
ZIP/Postal Code
50406
Country
Estonia

12. IPD Sharing Statement

Citations:
PubMed Identifier
32968425
Citation
Kasepalu T, Kuusik K, Lepner U, Starkopf J, Zilmer M, Eha J, Vahi M, Kals J. Remote ischaemic preconditioning influences the levels of acylcarnitines in vascular surgery: a randomised clinical trial. Nutr Metab (Lond). 2020 Sep 18;17:76. doi: 10.1186/s12986-020-00495-3. eCollection 2020.
Results Reference
derived
PubMed Identifier
32047578
Citation
Kasepalu T, Kuusik K, Lepner U, Starkopf J, Zilmer M, Eha J, Vahi M, Kals J. Remote Ischaemic Preconditioning Reduces Kidney Injury Biomarkers in Patients Undergoing Open Surgical Lower Limb Revascularisation: A Randomised Trial. Oxid Med Cell Longev. 2020 Jan 23;2020:7098505. doi: 10.1155/2020/7098505. eCollection 2020.
Results Reference
derived
PubMed Identifier
31126835
Citation
Kepler T, Kuusik K, Lepner U, Starkopf J, Zilmer M, Eha J, Lieberg J, Vahi M, Kals J. The Effect of Remote Ischaemic Preconditioning on Arterial Stiffness in Patients Undergoing Vascular Surgery: A Randomised Clinical Trial. Eur J Vasc Endovasc Surg. 2019 Jun;57(6):868-875. doi: 10.1016/j.ejvs.2018.12.002. Epub 2019 May 22.
Results Reference
derived

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

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