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OpenTrials
Completed

NCT Number: NCT02167152

Ischemic Preconditioning to Prevent Acute Kidney Injury

The purpose of this study is to learn about the impact of ischemic preconditioning in reducing contrast induced kidney damage in people with pre-existing kidney problems who are undergoing cardiac catheterization procedures.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

Ischemic preconditioning is thought to work by down-regulating pro-inflammatory gene expression and up-regulating anti-inflammatory gene expression in leukocytes. There is a local release of vasodilators, including adenosine and nitric oxide that are thought to have renal protective effects [16]. More is known regarding ischemic preconditioning in the heart, where it has been shown to decrease the adenine nucleotide pool, increase creatine phosphate and intracellular glucose, decrease ATP depletion, and lactate and H+ accumulation. This leads to sodium maintenance of the transmembrane sodium gradient that prevents intracellular edema. Ischemic preconditioning is thought to yield protection in the first minutes of reperfusion. Activation of the adenosine A1, bradykinin, and opioid receptors is thought to trigger protection. This is supported by the interference with protection if an adenosine receptor antagonist is administered. The role of reactive oxygen species as part of the protective mechanism has also been described via mitochondrial mKATP channels which lead to increased production of protective superoxide. Protein kinase C may also be involved in the protective mechanism of ischemic preconditioning, however the exact mechanism is unknown and controversial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stage III-IV chronic kidney disease (with serum creatinine at or above 1.4 mg/dl and eGFR 15-55 ml/min/1.73m2 calculated by the Modification of Diet in Renal Disease formula)
  • Undergoing planned coronary angiography (including both cardiac and peripheral vascular) and/or intervention at KUMC

Exclusion criteria

  • Patients with normal renal function (stage 0 to 2 chronic kidney disease and/or serum creatinine less than 1.4 mg/dl)
  • Inability or unwillingness to provide consent
  • Patients undergoing hemodialysis or peritoneal dialysis therapy
  • Patients with renal artery stenting
  • Hemodynamically unstable patients
  • Patients with acute or acute on chronic heart failure
  • Patients who are unable to undergo the study procedure due to any upper extremity problems such as prior amputation, prior radical mastectomy, etc
  • Patients who have not been hydrated prior to procedure using the standard protocols

Treatment and study plan

Ischemic preconditionin

Other

Ischemic preconditioning will be accomplished through 4 cycles of alternating 5-minute inflation and 5-minute deflation of an upper-arm blood pressure cuff to the patient's systolic blood pressure plus 50% to induce ischemia and reperfusion.

Primary outcomes

  1. Acute Kidney Injury

    Time frame: 1 year

    Defined as an absolute increase in serum creatinine greater than or equal to 0.5 mg/dl or a relative increase of greater than or equal to 25% compared with pre-procedural baseline as compared to 48-72 hours post-angiography.

Secondary outcomes

  1. Progression of kidney disease

    Time frame: 1 year

    Defined as change in serum creatinine and epidermal growth factor receptor (eGFR)

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jun 18, 2014
Registry last updated
Apr 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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