Ischemic Preconditioning to Prevent Acute Kidney Injury

NCT02167152 | Completed

• 1 other identifier: STUDY00000718
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Progression of kidney disease

  1 year

Study Arms (2)

Ischemic Preconditioning Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

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.

Control Group; Ischemic Preconditioning Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Kamal Gupta, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

• Patrick Tobbia, MD

  University of Kansas Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: June 18, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: February 1, 2016
• Last Updated: April 4, 2018

Record last verified: 2018-04

Locations

US (1)