NCT01260259

Brief Summary

Remote Ischemic Preconditioning (RIPC) is a treatment that may be associated with improved outcomes after cardiac surgery. It can be elicited noninvasively by using a tourniquet to elicit transient ischemia over a lower extremity. It is thought to promote anti-inflammatory and cell survival pathways, and thus protect remote organs against future ischemic injury. We hypothesize that compared to sham treatment, RIPC will be associated with decreased post-operative acute kidney, myocardial, and lung injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2010

Typical duration for not_applicable

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

December 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

September 18, 2013

Status Verified

September 1, 2013

Enrollment Period

2.7 years

First QC Date

December 13, 2010

Last Update Submit

September 16, 2013

Conditions

Congenital Heart DiseaseCardiopulmonary BypassMyocardial InjuryAcute Kidney InjuryAcute Lung Injury

Keywords

PediatricCardiacSurgeryCardiopulmonaryBypassMyocardialKidneyLungInjury

Outcome Measures

Primary Outcomes (2)

  • Incidence of acute kidney injury (AKI)

    Serum creatinine (SCr) will be measured at baseline, then on post-operative days 1, 2, and 3.

    72 hours

  • Incidence of acute myocardial injury

    Troponin-I will be measured at baseline, then 6, 12, 24, and 48 hours post-operative.

    48 hours

Secondary Outcomes (5)

  • Incidence of acute lung injury

    72 hours and duration of hospitalization

  • Hospitalization

    Duration of post-operative hospitalization

  • Mortality

    Duration of hospitalization, 30 days post-op, and at last follow-up

  • Biomarkers for AKI

    72 hours

  • Inflammation

    72 hours

Study Arms (2)

Remote Ischemic Preconditioning (RIPC)

EXPERIMENTAL
Procedure: RIPC

Control

SHAM COMPARATOR
Procedure: Control

Interventions

RIPCPROCEDURE

RIPC will be elicited in the operating room (OR) after anesthesia induction and before start of surgery. After placement of an arterial line, a tourniquet will be placed over a lower extremity. It will be inflated to 15 mmHg above systolic blood pressure for 5 minutes, and then deflated for 5 minutes. This cycle of inflation-deflation will be repeated another 3 times before surgery.

Remote Ischemic Preconditioning (RIPC)
ControlPROCEDURE

In OR, after induction of general anesthesia and arterial line placement, a deflated tourniquet will be placed over the lower extremity for 40 minutes.

Control

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age birth to 18 years Cardiac surgery with planned cardiopulmonary bypass

You may not qualify if:

  • Any contraindication to compression of lower extremity/extremities Body weight \<2 kg Active infection going into surgery On renal replacement therapy (RRT) or mechanical circulatory support going into surgery On inotropic support going into surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (1)

  • Law YM, Hsu C, Hingorani SR, Richards M, McMullan DM, Jefferies H, Himmelfarb J, Katz R. Randomized controlled trial of remote ischemic preconditioning in children having cardiac surgery. J Cardiothorac Surg. 2024 Jan 3;19(1):5. doi: 10.1186/s13019-023-02450-8.

    PMID: 38172875DERIVED

MeSH Terms

Conditions

Heart Defects, CongenitalAcute Kidney InjuryAcute Lung InjuryWounds and Injuries

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Christine W Hsu, MD

    Seattle Children's Hospital and University of Washington

    PRINCIPAL INVESTIGATOR

  • Yuk Law, MD

    Seattle Children's Hospital and University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 13, 2010

First Posted

December 15, 2010

Study Start

December 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

September 18, 2013

Record last verified: 2013-09

Locations

US(1)