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

NCT02476526 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-11-28

No results posted yet for this 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..

Conditions

Interventions

DRUG

Low Volume iso-osmolar non-ionic radio contrast medium

Intravenous injection of low volume (30 cc) iso-osmolar non-ionic radio contrast medium as part of the 64-MDCT Scanning procedure (intervention group only)

DRUG

Acetylcysteine Inhalation

Mucomyst 1200 mg po BID x 48 hours starting the day prior to the CT scan (both experimental and control groups)

DRUG

Sodium Bicarbonate Solution

Isotonic Sodium Bicarbonate 3 ml/kg/hr iv for 1 hour prior to the CT scan and for 6 hours after the CT scan (both experimental and control groups)

PROCEDURE

64-MDCT Scanning

Both experimental and control groups will undergo 64-MDCT scanning over the thoracic area

Sponsors & Collaborators

  • General Electric

    collaborator INDUSTRY

  • VA Greater Los Angeles Healthcare System

    lead FED

Principal Investigators

  • Dean T Yamaguchi, MD, PhD · VA Greater Los Angeles Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2017-11-20
Completion
2017-11-20

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02476526 on ClinicalTrials.gov