Clinical trial · Interventional
Safety of Low Dose IV Contrast CT Scanning in Chronic Kidney Disease
Safety of Low Dose Intravenous Contrast 64 Multi-Detector Computed Tomography Scanning in Patients With Chronic Kidney Disease
NCT02476526CI-TRIAL-00030534completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Kidney Disease | — | UNRESOLVED | — |
| Pulmonary Cancer | — | UNRESOLVED | — |
| Pulmonary Embolism | — | UNRESOLVED | — |
| Renal Artery Stenosis | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 64-MDCT Scanning | Procedure | — | UNRESOLVED |
| Acetylcysteine Inhalation | Drug | — | UNRESOLVED |
| Low Volume iso-osmolar non-ionic radio contrast medium | Drug | — | UNRESOLVED |
| Sodium Bicarbonate Solution | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Low Volume Contrast
- description
- 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
- interventionNames
- Drug: Low Volume iso-osmolar non-ionic radio contrast medium
- Drug: Acetylcysteine Inhalation
- Drug: Sodium Bicarbonate Solution
- Procedure: 64-MDCT Scanning
- type
- SHAM_COMPARATOR
- label
- Control
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDLevey 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. PMID 12859163