NCT05350683

Brief Summary

Introduction: Contrast induced nephropathy (CIN) is a major inconvenience in the use of iodinated contrast media (ICM) and it is associated with a significant increase in morbimortality and cost of hospitalization. Remote ischemic preconditioning (RIPC) is a non-invasive and cost-effective tissular protection technique that has proven beneficial in decreasing renal insult in patients receiving intravascular contrast. Aim: The primary outcome of this study is to evaluate the impact of RIPC on the incidence of CIN in patients undergoing endovascular aneurysm repair.Material and Methods: Patients suffering from aortic aneurysm were recruited prior to the administration of iodinated contrast media. Randomization was used to assign patients into the control/RIPC groups. Biochemical parameters determined renal function before and after surgery in immediate (24-72 hours) and at 30 days' follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2017

Typical duration for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

2.7 years

First QC Date

April 13, 2022

Last Update Submit

April 21, 2022

Conditions

Aortic AneurysmIschemic Preconditioning

Outcome Measures

Primary Outcomes (4)

  • Incidence of contrast induces nephropathy in patients udergoing evar

    serum creatinine

    48 hours

  • Incidence of contrast induces nephropathy in patients udergoing evar

    serum creatinine

    30 days

  • Incidence of contrast induces nephropathy in patients udergoing evar

    Estimated glomerular filtrate

    48 hours

  • Incidence of contrast induces nephropathy in patients udergoing evar

    Estimated glomerular filtrate

    30 days

Secondary Outcomes (4)

  • Other variables

    48 hours

  • Other variables

    48 hours

  • Other variables

    30 days

  • Other variables

    30 days

Study Arms (2)

Control group

NO INTERVENTION

EVAR patients no ischemic preconditioning

Preconditioning Group

ACTIVE COMPARATOR

EVAR patients with remote ischemic preconditioning

Procedure: Remote ischemic preconditioning

Interventions

Remote ischemic preconditioningPROCEDURE

In the 12 hours prior to surgery, the principal investigator performed the remote ischemic preconditioning (RIPC) following the protocol: 4 cycles of inflation/deflation of a pneumatic arterial tourniquet on the non-dominant upper extremity. Considering inflated a pressure of 50mmHg above systolic blood pressure for 5 minutes, followed by 5 minutes of deflation. Patients included in the preconditioning group were randomized at a rate of 1:1 consecutively.

Preconditioning Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled for elective aortic surgery treated by endovascular repair

You may not qualify if:

  • peripheral artery disease in the upper limbs
  • chronic kidney disease grade V on replacement therapy with haemodialysis, - - patients with cardiac decompensation at the time of the interventio
  • those who did not tolerate the preparation by ischemic preconditioning in the non-dominant upper limb or who refused to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico Universitario

Valladolid, Spain

Location

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Diana Gutierrez

    Member

    PRINCIPAL INVESTIGATOR

  • Enrique San Norberto

    Member

    STUDY DIRECTOR

  • Elena Garcia

    Member

    STUDY CHAIR

  • Liliana Domingos

    Member

    STUDY CHAIR

  • Cintia Flota

    Member

    STUDY CHAIR

  • Carlos Vaquero

    Member

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2022

First Posted

April 28, 2022

Study Start

January 1, 2017

Primary Completion

September 17, 2019

Study Completion

May 20, 2020

Last Updated

April 28, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)