Recruiting
Phase 3

Ultra-Low Contrast

Sponsor:

Tulane University

Code:

NCT05906758

Conditions

Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Angiography

Study Details

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.

Conditions

Acute Kidney Injury

Study ID

NCT05906758

Start date

Sep 5, 2025

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Immediate intervention arm

Immediate angiography will be performed within 24 hours of enrollment. Omnipaque contrast will be administered. 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.

placebo comparator: Delayed intervention arm

Delayed angiography will be performed after kidney function stabilizes.

Interventions

Angiography

Coronary angiography with less than 20cc of contrast materials

Primary outcome measure

  • Change in incidence of Contrast Induced Nephropathy (CIN) [ Time Frame: Within 7 days ]

Central Contacts and Locations

Central contacts

Zach Rozenbaum, MD

504-988-5493zrozenbaum@tulane.edu

Locations

Tulane University Medical Center

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Zach Rozenbaum, MD

504-988-5493zrozenbaum@tulane.edu

Principal Investigator:

Zach Rozenbaum, MD

University Medical Center

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Zach Rozenbaum, MD

504-988-5493zrozenbaum@tulane.edu

Principal Investigator:

Zach Rozenbaum, MD

More Information

Sponsor

Tulane University

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

  • Coronary angiography
  • Ultra low contrast

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tulane University on 2026-05-18.