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Completed

NCT Number: NCT02476526

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

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 information

About this study

The use of radio contrast medium enhances the image quality of CT scans. However, contrast CT is avoided in patients with CKD for fear of contrast-induced nephropathy. The current standard of care for these patients is CT without contrast. Taking advantage of fast scanning capabilities of modern CT scanners (64-Multi-Detector CT), the current investigators have developed a method to use low volume iso-osmolar non-ionic radio contrast medium (30 cc) which can be used in a selected group of adult patients with mild to moderate stable CKD (eGFR 16-60 ml/min/m^2 for at least 12 months), who require thoracic CT imaging for diagnostic purposes. Up to 100 patients who meet the inclusion/exclusion criteria will be randomized to standard care (no-contrast, 50 controls) or low volume contrast CT (50 intervention group). The peak increase of serum creatinine levels within 72 hours after the CT procedure will be measured as an outcome variable for comparison between the two groups, as well as a safety monitoring variable in the intervention group (25% increase is the upper threshold).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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.

Exclusion 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

Treatment and study plan

Low Volume iso-osmolar non-ionic radio contrast medium

Drug

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)

Other names: Visipaque 320

Acetylcysteine Inhalation

Drug

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

Other names: Mucomyst

Sodium Bicarbonate Solution

Drug

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)

Other names: Isotonic Sodium Bicarbonate

64-MDCT Scanning

Procedure

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

Other names: 64-Multi-Detector Computed Tomography Scanning

Primary outcomes

  1. Peak Serum Creatinine Level

    Time frame: Up to 72 hours after intervention

    The peak serum creatinine increase over baseline within 72 hours after intervention is the outcome variable. This variable is used for comparison between two groups, as well as for safety monitoring in the intervention group (25% increase is the upper threshold)

Sponsors and collaborators

Lead sponsor

VA Greater Los Angeles Healthcare System

Fed

Collaborators

  • General Electric

Registry information

Official study title

Safety of Low Dose Intravenous Contrast 64 Multi-Detector Computed Tomography Scanning in Patients With Chronic Kidney Disease

Important dates

Study start
2008
Primary completion
2017
Study completion
2017
First posted
Jun 19, 2015
Registry last updated
Nov 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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