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

NCT ID: NCT02476526

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2017-11-20

Brief Summary

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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..

Detailed Description

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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).

Conditions

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Chronic Kidney Disease Pulmonary Embolism Renal Artery Stenosis Pulmonary Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Low Volume Contrast

Subjects in this arm will receive a single intravenous injection of low volume iso-osmolar non-ionic radio contrast medium, prior to undergoing 64-MDCT scanning. The use of low volume radio contrast medium constitutes the intervention. Both experimental and control groups receive a) acetylcysteine inhalation (Mucomyst) 1200 mg po BID x 48 hours starting the day prior to the CT scan; and b) isotonic Sodium Bicarbonate Solution 3ml/kg/hr iv for 1 hour prior to the CT scan and for 6 hours after the CT scan

Group Type EXPERIMENTAL

Low Volume iso-osmolar non-ionic radio contrast medium

Intervention Type 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)

Acetylcysteine Inhalation

Intervention Type DRUG

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

Sodium Bicarbonate Solution

Intervention Type 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)

64-MDCT Scanning

Intervention Type PROCEDURE

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

Control

Subjects in this arm will undergo 64-MDCT scanning without Radio Contrast Medium (RCM). Both experimental and control groups receive a) acetylcysteine inhalation (Mucomyst) 1200 mg po BID x 48 hours starting the day prior to the CT scan; and b) isotonic Sodium Bicarbonate Solution 3ml/kg/hr iv for 1 hour prior to the CT scan and for 6 hours after the CT scan

Group Type SHAM_COMPARATOR

Acetylcysteine Inhalation

Intervention Type DRUG

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

Sodium Bicarbonate Solution

Intervention Type 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)

64-MDCT Scanning

Intervention Type PROCEDURE

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

Interventions

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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)

Intervention Type DRUG

Acetylcysteine Inhalation

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

Intervention Type 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)

Intervention Type DRUG

64-MDCT Scanning

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

Intervention Type PROCEDURE

Other Intervention Names

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Visipaque 320 Mucomyst Isotonic Sodium Bicarbonate 64-Multi-Detector Computed Tomography Scanning

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Electric

INDUSTRY

Sponsor Role collaborator

VA Greater Los Angeles Healthcare System

FED

Sponsor Role lead

Responsible Party

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Bruce Barack

Section Chief, Thoracic Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dean T Yamaguchi, MD, PhD

Role: STUDY_DIRECTOR

VA Greater Los Angeles Healthcare System

Locations

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VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Levey AS, Coresh J, Balk E, Kausz AT, Levin A, Steffes MW, Hogg RJ, Perrone RD, Lau J, Eknoyan G; National Kidney Foundation. National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med. 2003 Jul 15;139(2):137-47. doi: 10.7326/0003-4819-139-2-200307150-00013.

Reference Type BACKGROUND
PMID: 12859163 (View on PubMed)

Other Identifiers

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Barack0001

Identifier Type: -

Identifier Source: org_study_id