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CompletedNCT00821522Updated Nov 17, 2021

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

A Phase 1 interventional study of Remote Ischemic Preconditioning in Acute Kidney Insufficiency, Acute Renal Insufficiency and Acute Kidney Injury, sponsored by Robert Kramer, MD. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-11-17.

Sponsored by Robert Kramer, MD · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Kidney Insufficiency
  • Acute Renal Insufficiency
  • Acute Kidney Injury
  • Ischemic Preconditioning

Keywords

  • Acute Kidney Insufficiency
  • Acute Renal Insufficiency
  • Acute Kidney Injury
  • Cardiac Surgical Procedures
  • Ischemic Preconditioning
03

In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's enrollment of 120 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

This is the only study on the registry with Robert Kramer, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient undergoing heart surgery on cardiopulmonary bypass.

Exclusion criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Preconditioning

    Procedure: Remote Ischemic Preconditioning

  • No intervention
    Control

    Standard clinical management during cardiac surgery.

Interventions

  • ProcedureRemote Ischemic Preconditioning

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

06

What researchers measure

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.

    Time frame: 48 hours after surgery.

Secondary outcomes

  1. Oliguria.

    Time frame: 12 hours after surgery.

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

    Time frame: 3 hours after cardiopulmonary bypass.

07

Study locations

1 site
  • Maine Medical Center
    Portland, Maine 04102, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00821522
Lead sponsor
Robert Kramer, MD
Collaborators
MaineHealth
Responsible party
Robert Kramer, MD (Thoracic Surgery, MD, MaineHealth) — Sponsor-investigator
First posted
Jan 13, 2009
Start date
Nov 2008
Primary completion
Mar 2010
Completion
May 2010
Last update
Nov 17, 2021

Study contacts

Robert F Zimmerman, MD
principal investigator · MaineHealth

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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