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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: Ischemic preconditionin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ischemic Preconditioning Group; Participants randomized to this group will have a blood pressure cuff placed on each arm, and these cuffs will be inflated one at a time to a pressure calculated based on the person's blood pressure.	Other: Ischemic preconditionin; 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.
Active Comparator: Control Group; Participants randomized to this group will have a blood pressure cuff placed on each arm, and these cuffs will be inflated one at a time to a set pressure (30mmHg, or millimeters of mercury on a blood pressure measuring machine).	Other: Ischemic preconditionin; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Kidney Injury	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of kidney disease	Defined as change in serum creatinine and epidermal growth factor receptor (eGFR)	1 year

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Kamal Gupta, MD, University of Kansas Medical Center; Study Director: Patrick Tobbia, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: June 16, 2014
• First Submitted That Met QC Criteria: June 16, 2014
• First Posted (Estimate): June 18, 2014

Study Record Updates

• Last Update Posted (Actual): April 4, 2018
• Last Update Submitted That Met QC Criteria: April 2, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: STUDY00000718 (Other Identifier: University of Oregon)