The Influence of Remote Ischemic Preconditioning on Acute... | NCT00821522

Studies
The Influence of Remote Ischemic Preconditioning on Acute Kidney Injury After Cardiac Surgery

NCT00821522

Sponsor

Robert Kramer, MD

Status

Completed

Last Update Posted

Nov 17, 2021Actual

Enrollment

120Actual

Phase

Phase 1

Conditions

Acute Kidney Insufficiency
Acute Renal Insufficiency
Acute Kidney Injury
Ischemic Preconditioning

Interventions

Remote Ischemic Preconditioning

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Mar 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Jan 9, 2009

First Submission Date that Met QC Criteria

Jan 9, 2009

First Posted Date

Jan 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2021

Last Update Posted Date

Nov 17, 2021Actual

Name	Class
MaineHealth	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Preconditioning	Active Comparator		Procedure: Remote Ischemic Preconditioning
Control	No Intervention	Standard clinical management during cardiac surgery.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Remote Ischemic Preconditioning	Procedure	Three 5-minute intervals of leg ischemia induced by tourniquet inflation, prior to initiation of cardiopulmonary bypass.	Preconditioning

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Oliguria.		12 hours after surgery.
Incidence of acute kidney injury as defined by post-operative elevation in NGAL.		3 hours after cardiopulmonary bypass.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient undergoing heart surgery on cardiopulmonary bypass.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert F Zimmerman, MD	MaineHealth	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maine Medical Center		Portland	Maine	04102	United States

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided