Remote Ischaemic Preconditioning to Prevent Dialysis Induced Cardiac Injury

NCT ID: NCT02630355

Last Updated: 2020-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-12-31

Brief Summary

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This study evaluates the use of remote ischaemic preconditioning for the prevention of dialysis induced cardiac injury. The study uses four arms to test different frequencies of application to ascertain which, if any, is most successful at reducing dialysis induced cardiac injury.

Detailed Description

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Conditions

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Hemodialysis Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Inflation of blood pressure cuff in lower limb to 40mmHg for four cycles of 5 minutes inflation and then deflation

Group Type SHAM_COMPARATOR

Remote Ischaemic Preconditioning

Intervention Type OTHER

Inflation of blood pressure cuff in lower limb

Low Intensity

Inflation of blood pressure cuff in lower limb to 200mmHg for two cycles of 5 minute inflation and then deflation.

Group Type ACTIVE_COMPARATOR

Remote Ischaemic Preconditioning

Intervention Type OTHER

Inflation of blood pressure cuff in lower limb

Standard Intensity

Inflation of blood pressure cuff in lower limb to 200mmHg for four cycles of 5 minute inflation and then deflation.

Group Type ACTIVE_COMPARATOR

Remote Ischaemic Preconditioning

Intervention Type OTHER

Inflation of blood pressure cuff in lower limb

High Intensity

Inflation of blood pressure cuff in lower limb to 200mmHg for four cycles of 5 minute inflation and deflation on weekly basis for four consecutive weeks.

Group Type ACTIVE_COMPARATOR

Remote Ischaemic Preconditioning

Intervention Type OTHER

Inflation of blood pressure cuff in lower limb

Interventions

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Remote Ischaemic Preconditioning

Inflation of blood pressure cuff in lower limb

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients having haemodialysis treatment at least 3 times per week at a London Health Sciences Centre facility
2. Male and female, age≄16 years old.

2. Exposure to haemodialysis for \<90 days prior to recruitment
3. Severe heart failure (New York Heart Association grade IV)
4. Cardiac transplant recipients
5. Mental incapacity to consent
6. Declined to participate
7. Taking cyclosporin
8. Taking ATP-sensitive potassium channel opening or blocking drugs
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academic Medical Organization of Southwestern Ontario

OTHER

Sponsor Role collaborator

Western University, Canada

OTHER

Sponsor Role lead

Responsible Party

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Christopher McIntyre

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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R-15-091

Identifier Type: -

Identifier Source: org_study_id

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