NCT01023152

Brief Summary

The purpose of this study is to study the effect of remote ischemic preconditioning on acute kidney injury in patients undergoing heart valve replacement surgery with cardiopulmonary bypass.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

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

First Submitted

Initial submission to the registry

December 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
Last Updated

December 2, 2009

Status Verified

December 1, 2009

First QC Date

December 1, 2009

Last Update Submit

December 1, 2009

Conditions

Study Arms (1)

Automated cuff-inflator

EXPERIMENTAL
Procedure: Automated cuff-inflator

Interventions

RIPC protocol consisted of three 10-min cycles of lower limb ischemia at an inflation pressure of 250 mmHg induced by an automated cuff-inflator placed on the upper leg with an intervening 10 min of reperfusion during which the cuff was deflated.

Automated cuff-inflator

Eligibility Criteria

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

You may qualify if:

  • patients undergoing complex valve surgery.

You may not qualify if:

  • older than 80 years
  • those with left main disease \>50%, or hepatic or pulmonary disease
  • active infective endocarditis
  • left ventricular ejection fraction \<30%
  • myocardial infarction (MI) within 3 weeks
  • pre-existing renal dysfunction (serum creatinine (Cr) level \>1.4 mg/dl), and those with peripheral vascular disease affecting the lower limbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 1, 2009

First Posted

December 2, 2009

Last Updated

December 2, 2009

Record last verified: 2009-12