Health TrialsbyHealthPanel

Ultra-Low Contrast Angiography in AKI

ConditionAcute Kidney Injury
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorTulane University

About this trial

The aim of this study is to evaluate the safety of ultra-low contrast coronary angiography in patients with pre-existing acute kidney injury.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hospitalized patients who have AKI at admission or who develop AKI during admission and require invasive coronary angiography will be included in the trial.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Angiography

    Procedure/Surgery

    Coronary angiography with less than 20cc of contrast materials

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Immediate intervention armActive comparator 1 intervention
Group B: Delayed intervention armPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Within 7 days

Secondary outcomes

1

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

Time frame
Within 7 days
2

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

Time frame
Within 7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tulane University

Lead sponsor

Source ClinicalTrials.gov
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