NCT02689414

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

2.1 years

First QC Date

February 3, 2016

Last Update Submit

February 26, 2018

Conditions

Abdominal Aortic AneurysmPeripheral Artery DiseaseCarotid Artery Stenosis

Keywords

Atherosclerosis

Outcome Measures

Primary Outcomes (2)

  • Carotide-femoral pulse velocity

    Measured with Sphygmocor XCEL * baseline characteristics are measured before surgery * measuring is repeated 24 h after surgery

    24 h

  • Augmentation index

    Measured with Sphygmocor XCEL * baseline characteristics are measured before surgery * measuring is repeated 24 h after surgery

    24 h

Secondary Outcomes (13)

  • Cardiac markers

    24 h

  • Traditional biomarkers of renal function

    24 h

  • Markers of inflammation and oxidative stress

    24 h

  • Duration of hospital stay

    30 days

  • Duration of intesive care unit stay

    30 days

  • +8 more secondary outcomes

Study Arms (2)

Remote ischaemic preconditioning

EXPERIMENTAL

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

Control to RIPC

SHAM COMPARATOR

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

Interventions

Remote ischaemic preconditioningPROCEDURE

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.

Also known as: RIPC
Remote ischaemic preconditioning
Control to RIPCPROCEDURE

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.

Control to RIPC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tartu University Hospital

Tartu, Tartu County, 50406, Estonia

Location

Related Publications (4)

  • Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.

    PMID: 36645250DERIVED

  • 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.

    PMID: 32968425DERIVED

  • 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.

    PMID: 32047578DERIVED

  • 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.

    PMID: 31126835DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalPeripheral Arterial DiseaseCarotid StenosisAtherosclerosis

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesArteriosclerosisArterial Occlusive DiseasesPeripheral Vascular DiseasesCarotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • 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

    STUDY CHAIR

  • Jaak Kals, MD-PhD

    Tartu University Hospital

    PRINCIPAL INVESTIGATOR

  • Karl Kuusik, MD

    University of Tartu

    STUDY CHAIR

  • Teele Kepler, MD

    University of Tartu

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinic of Surgery, Department of Vascular Surgery, cardiovascular surgeon; MD-PhD

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 24, 2016

Study Start

January 1, 2016

Primary Completion

February 8, 2018

Study Completion

February 1, 2019

Last Updated

February 28, 2018

Record last verified: 2018-02

Locations

ES(1)