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Ultra-Low Contrast Angiography in AKI

Primary Purpose

Acute Kidney Injury

Status
Not yet recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Angiography
Sponsored by
Tulane University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring Coronary angiography, Ultra low contrast

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hospitalized patients who have AKI at admission or who develop AKI during admission and require invasive coronary angiography will be included in the trial. Exclusion Criteria: Stabilized renal function manifested by unchanged or downtrending serum creatinine during a 24-hour period prior to enrollment. Contraindication for invasive coronary angiography other than AKI. Percutaneous coronary intervention is indicated and cannot be postponed by 7 days. Need for renal replacement therapy before coronary angiography or planned renal replacement therapy after coronary angiography (if premeditated before coronary angiography). Administration of intravascular contrast media during 7 days prior to the coronary angiography or within 6 days after coronary angiography. Pregnant patients, prisoners, cognitively impaired subjects, age below 18 years, unable or unwilling to provide informed consent.

Sites / Locations

  • Tulane University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Immediate intervention arm

Delayed intervention arm

Arm Description

Immediate angiography will be performed within 24 hours of enrollment. Serum creatinine will be collected on enrollment, within 6 hours before coronary angiography, and at 24h, 48h and 1-week after the angiography, as expected in common practice. Pre- and post-hydration administration will be at the discretion of the treating physician. In case percutaneous coronary intervention is indicated it will be schedule for 7 days after angiography.

Delayed angiography will be performed after kidney function stabilizes

Outcomes

Primary Outcome Measures

Change in incidence of Contrast Induced Nephropathy (CIN)
CIN is defined as an increase in serum creatinine by 0.5mg/dl or a relative rise of 25% from the baseline value. The investigators will measure the incidence of CIN by the increase in serum creatinine to see if the incidence will be the same in both arms whether the patient received the immediate angiography or if it was delayed until kidney function has been stabilized.

Secondary Outcome Measures

Incidence of earlier occurrence of CIN
The investigators will measure serum creatinine at 24, 48 hours and at 1 week to measure if the occurrence of CIN will happen earlier in 1 arm than the other
Incidence of renal replacement therapy at up to 7 days post-angiography
The investigators will measure the incidence of renal replacement therapy by monitoring if the patient will undergo dialysis within 7 days post angiography

Full Information

First Posted
June 7, 2023
Last Updated
June 7, 2023
Sponsor
Tulane University
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1. Study Identification

Unique Protocol Identification Number
NCT05906758
Brief Title
Ultra-Low Contrast Angiography in AKI
Official Title
Randomized Controlled Trial of Ultra-Low Contrast Coronary Angiography During Acute Kidney Injury (AKI)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tulane University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to evaluate the safety of ultra-low contrast coronary angiography in patients with pre-existing acute kidney injury.
Detailed Description
The study is a non-inferiority open-label randomized controlled trial. Hospitalized patients who have AKI at admission or who develop AKI during admission and require invasive coronary angiography will be included in the trial. Once indication for invasive coronary angiography is determined, patients will be randomized to immediate angiography or to delayed angiography after renal function stabilizes. Immediate angiography will be performed within 24 of enrollment. Serum creatinine will be collected on enrollment, within 6 hours before coronary angiography, and at 24h, 48h and 1-week after the angiography, as expected in common practice. Pre- and post-hydration administration will be at the discretion of the treating physician. In case percutaneous coronary intervention is indicated it will be schedule for 7 days after angiography. Definitions: AKI is defined as an increase in serum creatinine by ≥50% from baseline within 7 days or an increase in serum creatinine by ≥0.3 mg/dl within 2 days. CIN is defined as an increase in serum creatinine by 0.5mg/dl or a relative rise of 25% from the baseline value.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Coronary angiography, Ultra low contrast

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate intervention arm
Arm Type
Active Comparator
Arm Description
Immediate angiography will be performed within 24 hours of enrollment. Serum creatinine will be collected on enrollment, within 6 hours before coronary angiography, and at 24h, 48h and 1-week after the angiography, as expected in common practice. Pre- and post-hydration administration will be at the discretion of the treating physician. In case percutaneous coronary intervention is indicated it will be schedule for 7 days after angiography.
Arm Title
Delayed intervention arm
Arm Type
Placebo Comparator
Arm Description
Delayed angiography will be performed after kidney function stabilizes
Intervention Type
Procedure
Intervention Name(s)
Angiography
Intervention Description
Coronary angiography with less than 20cc of contrast materials
Primary Outcome Measure Information:
Title
Change in incidence of Contrast Induced Nephropathy (CIN)
Description
CIN is defined as an increase in serum creatinine by 0.5mg/dl or a relative rise of 25% from the baseline value. The investigators will measure the incidence of CIN by the increase in serum creatinine to see if the incidence will be the same in both arms whether the patient received the immediate angiography or if it was delayed until kidney function has been stabilized.
Time Frame
Within 7 days
Secondary Outcome Measure Information:
Title
Incidence of earlier occurrence of CIN
Description
The investigators will measure serum creatinine at 24, 48 hours and at 1 week to measure if the occurrence of CIN will happen earlier in 1 arm than the other
Time Frame
Within 7 days
Title
Incidence of renal replacement therapy at up to 7 days post-angiography
Description
The investigators will measure the incidence of renal replacement therapy by monitoring if the patient will undergo dialysis within 7 days post angiography
Time Frame
Within 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospitalized patients who have AKI at admission or who develop AKI during admission and require invasive coronary angiography will be included in the trial. Exclusion Criteria: Stabilized renal function manifested by unchanged or downtrending serum creatinine during a 24-hour period prior to enrollment. Contraindication for invasive coronary angiography other than AKI. Percutaneous coronary intervention is indicated and cannot be postponed by 7 days. Need for renal replacement therapy before coronary angiography or planned renal replacement therapy after coronary angiography (if premeditated before coronary angiography). Administration of intravascular contrast media during 7 days prior to the coronary angiography or within 6 days after coronary angiography. Pregnant patients, prisoners, cognitively impaired subjects, age below 18 years, unable or unwilling to provide informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zach Rozenbaum, MD
Phone
504-988-5493
Email
zrozenbaum@tulane.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zach Rozenbaum, MD
Organizational Affiliation
Tulane University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tulane University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zach Rozenbaum, MD
Phone
504-988-5493
Email
zrozenbaum@tulane.edu
First Name & Middle Initial & Last Name & Degree
Zach Rozenbaum, MD

12. IPD Sharing Statement

Learn more about this trial

Ultra-Low Contrast Angiography in AKI

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