Safety of Low Dose IV Contrast CT Scanning in Chronic Kidney Disease

Study summary

The purpose of this study is to show that the use of low volume iso-osmolar non-ionic radio contrast medium (30 cc) in a thoracic CT Scanning procedure in a selected group of patients with chronic kidney disease (CKD) will avoid contrast induced nephropathy (CIN) in comparison to a similar group of patients with CKD who receive no contrast medium..

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Key things to know

Main goalDiagnostic

This describes the study’s primary purpose.

What is being studiedLow Volume iso-osmolar non-ionic radio contrast medium and Acetylcysteine Inhalation

Plus 2 other study approaches.

Who it may be forChronic Kidney Disease · Pulmonary Embolism

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 28, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 4

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?VA Greater Los Angeles Healthcare System

Study sponsor

Study overview

What this study is about

Purpose: Diagnostic
Study type: Interventional
Phase: Phase 4
Sponsor: VA Greater Los Angeles Healthcare System
Interventions being studied: Drug: Low Volume iso-osmolar non-ionic radio contrast medium; Drug: Acetylcysteine Inhalation; Drug: Sodium Bicarbonate Solution; Procedure: 64-MDCT Scanning

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Subjects with documented stable Chronic Kidney Disease (CKD) defined as a stable eGFR 16-60 ml/min/m\^2 for ≥ 12 months; and
Referred to CT scanning procedure to evaluate pulmonary embolism, pulmonary malignancy, acute aortic syndromes, or renal artery stenosis.

Reasons someone may not be able to joinExclusion criteria

CKD Stages 1, 2 and 5
Stage 3-4 congestive heart failure (CHF)
Irregular supraventricular tachycardia
Allergic to iodinated Radio Contrast Medium (RCM)
Allergic to Mucomyst
Pregnancy
Evidence of acute renal failure (ARF)
Serum bicarbonate either less than 20 meq/L or greater than 35 meq/L
Hydration with a bicarbonate solution is contraindicated or considered unsafe by the subject's caring physicians

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

VA Greater Los Angeles Healthcare SystemLos Angeles, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 28, 2017. Always confirm current availability with the study team.

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