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

February 26, 2018 updated by: Jaak Kals, Tartu University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
    • Tartu County
      • Tartu, Tartu County, Estonia, 50406
        • Tartu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 h
Augmentation index
Time Frame: 24 h

Measured with Sphygmocor XCEL

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of hospital stay
Time Frame: 30 days
30 days
Cardiac markers
Time Frame: 24 h
Troponin T, Creatine kinase-MB, N-terminal pro-brain natriuretic peptiide (NT-ProBNP).
24 h
Traditional biomarkers of renal function
Time Frame: 24 h
Creatinine, Urea
24 h
Markers of inflammation and oxidative stress
Time Frame: 24 h
Oxidized low-density lipoprotein (oxLDL), Interleukin-18 (IL-18), Myeloperoxidase (MPO), Isoprostane.
24 h
Duration of intesive care unit stay
Time Frame: 30 days
30 days
Cardiac event
Time Frame: 10 days
Myocardial infarction or cardiac arrest
10 days
Postoperative complications
Time Frame: 10 days
Surgical wound infection or haematoma, Acute limb ischaemia, Acute deep vein thrombosis, Limb amputation, Pneumonia, Urinary tract infection.
10 days
1- year mortality
Time Frame: 1 year
1 year
Complications of remote ishcaemic preconditioning
Time Frame: 10 days
Upper-extremity deep vein thrombosis, Acute upper limb ischaemia.
10 days
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),
24 h
Estimated glomerular filtration rate
Time Frame: 24 h
eGFR
24 h
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.
24 h
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
24 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tartu University Hospital

Investigators

  • 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 Director: Teele Kepler, MD, University of Tartu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

February 8, 2018

Study Completion

February 1, 2019

Study Registration Dates

First Submitted

February 3, 2016

First Submitted That Met QC Criteria

February 18, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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