NCT00821522

Brief Summary

Acute kidney injury is associated with cardiopulmonary bypass during heart surgery and its pathogenesis is similar to that of ischemia-reperfusion injury. Remote ischemic preconditioning attenuates myocardial ischemia-reperfusion injury in patients undergoing coronary bypass surgery. The investigators hypothesize that such preconditioning reduces the incidence of acute kidney injury associated with cardiopulmonary bypass.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2008

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

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

1.3 years

First QC Date

January 9, 2009

Last Update Submit

November 9, 2021

Conditions

Acute Kidney InsufficiencyAcute Renal InsufficiencyAcute Kidney InjuryIschemic Preconditioning

Keywords

Acute Kidney InsufficiencyAcute Renal InsufficiencyAcute Kidney InjuryCardiac Surgical ProceduresIschemic Preconditioning

Outcome Measures

Primary Outcomes (1)

  • Incidence of acute kidney injury, after surgery, as defined by elevation in serum creatinine greater than or equal to 0.3 mg/dl.

    48 hours after surgery.

Secondary Outcomes (2)

  • Oliguria.

    12 hours after surgery.

  • Incidence of acute kidney injury as defined by post-operative elevation in NGAL.

    3 hours after cardiopulmonary bypass.

Study Arms (2)

Preconditioning

ACTIVE COMPARATOR
Procedure: Remote Ischemic Preconditioning

Control

NO INTERVENTION

Standard clinical management during cardiac surgery.

Interventions

Remote Ischemic PreconditioningPROCEDURE

Three 5-minute intervals of leg ischemia induced by tourniquet inflation, prior to initiation of cardiopulmonary bypass.

Preconditioning

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient undergoing heart surgery on cardiopulmonary bypass.

You may not qualify if:

  • Known peripheral vascular disease of the lower extremities associated with active skin necrosis or infection.
  • End-stage renal disease.
  • Inability to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maine Medical Center

Portland, Maine, 04102, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Robert F Zimmerman, MD

    MaineHealth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Thoracic Surgery, MD

Study Record Dates

First Submitted

January 9, 2009

First Posted

January 13, 2009

Study Start

November 1, 2008

Primary Completion

March 1, 2010

Study Completion

May 1, 2010

Last Updated

November 17, 2021

Record last verified: 2021-11

Locations

US(1)