Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction
RIPE
1 other identifier
interventional
200
1 country
19
Brief Summary
The purpose of this study is to compare renal toxicity of Iodixanol and Iopromide in patients with renal dysfunction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2012
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 16, 2012
CompletedFirst Posted
Study publicly available on registry
April 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedOctober 16, 2013
October 1, 2013
1.7 years
April 16, 2012
October 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
to evaluate the change in Glomerular Filtration Rate levels by Estimated Glomerular Filtration Rate
days 3 and 7
Secondary Outcomes (3)
In each group(Iodixanol group and Iopromide group), the proportion of patients exhibiting an increases of serum creatinine in different range(<10%,10%~25%, and ≥25%), comparing with baseline level.
days 3 and 7
Incidence of hemodialysis
days 3 and 7
Changes of Cystatin C level from baseline
days 1 and 3
Study Arms (2)
Iodixanol
EXPERIMENTALiopromide
ACTIVE COMPARATORInterventions
1. coronary angiography, 32gI/100ml, 40～60 ml once injection 2. left ventricular, aortic root and selective coronary angiography, 32gI/100ml, 30～60 ml once injection
coronary angiography, 370mgI/ml(0.769gIopromide/ml),5～8 ml once injection
Eligibility Criteria
You may qualify if:
- Provides written Informed Consent and is willing to comply with protocol requirements
- Is referred for cardiac angiography, with or without PCI
- Has a documented predose serum creatinine level of 1.5～3.5 mg/dl for men and 1.3～3.0 mg/dl for women
- Serum creatinine levels of twice tests conform with the baseline criteria, and the difference of twice serum creatinine tests is not more than 30%(first test: within 3 month,prior to enrollment; second test: at enrollment)
You may not qualify if:
- Has a history of hypersensitivity to iodine-containing compounds
- Has end-stage renal disease
- Has kidney transplantation
- Has creatinine clearance rates \>60 ml/min in last 3 months
- Has acute coronary syndrome with heart failure(above class II in accordance with Killip or class III in accordance with the classification of the New York Heart Association (NYHA)) and shock
- Patients with cancer
- Has diabetes with serious complications, other kidney organs
- Patients with serious blood system disease
- Heart failure \[class III\~Ⅳ in accordance with the classification of the New York Heart Association (NYHA) and (or) pulmonary edema\]
- Patients with hepatic insufficiency\[3 times as ALT and (or) AST normal reference value limit\]
- Has received an iodinated contrast agent within 14 days prior to the administration of the study agent
- Is scheduled to receive an iodinated contrast agent within 7 days after administration of the study agent
- Has acute renal failure or end-stage renal disease requiring dialysis in the past 3 months
- Use of 3 days continuously nonsteroidal anti-inflammatory drugs within 1 week of the procedure
- Patients with hypotension \[(SBP\<80 mmHg for over 1h and needing Medication or intraaortic balloon counterpulsation(IABP) \]
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yong Huolead
Study Sites (19)
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
Peking University First Hospital
Beijing, Beijing Municipality, 100044, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Guangdong Academy Of Medical Sciences Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital Of Guangxi Medical University
Nanning, Guangxi, 530021, China
The People's Hospital Of Hebei Province
Shijiazhuang, Hebei, 050051, China
Henan Provincial People's Hospital
Luoyang, Henan, 450000, China
The Second Affiliated Hospital To Nanchang University
Nanchang, Jiangxi, 330006, China
The People's Hospital Of Liaoning Province
Shenyang, Liaoning, 110016, China
The Affiliated Hospital Of Medical College Qingdao University
Qingdao, Shandong, 266003, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 030024, China
Peking University People's Hospital
Beijing, 100044, China
Pla Navy General Hospital
Beijing, 100048, China
The Central Hospital Of China Aerospace Corporation
Beijing, 100049, China
Chinese PLA General Hospital
Beijing, 100853, China
Xinqiao Hospital, Third Military Medical University
Chongqing, 400037, China
Renji Hospital ，Shanghai Jiao Tong University School Of Medicine
Shanghai, 200001, China
Shanghai Chest Hospital Affiliated To Shanghai Jiaotong University
Shanghai, 200030, China
Shanghai First People's Hospital
Shanghai, 200080, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
April 16, 2012
First Posted
April 18, 2012
Study Start
April 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
October 16, 2013
Record last verified: 2013-10