RIPE: Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction

Sponsor

Yong Huo (Other)

Overall Status

Unknown status

CT.gov ID

NCT01580046

Collaborator

(none)

200

Enrollment

Locations

Arms

Duration (Months)

10.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare renal toxicity of Iodixanol and Iopromide in patients with renal dysfunction.

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure, Chronic	Drug: iodixanol Drug: iopromide	Phase 4

Detailed Description

The study is designed to compare renal toxicity of Iodixanol and Iopromide after coronary angiography or percutaneous coronary intervention (PCI) in patient with Chronic Kidney Disease, considering original renal function and adequate hydration. The risk of varying degree of renal impairment, changes of serum Cys C level will also be evaluated.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction-a Multicentre, Single Blind, Randomized Controlled, Prospective Trial

Study Start Date :

Apr 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Iodixanol	Drug: iodixanol coronary angiography, 32gI/100ml, 40～60 ml once injection left ventricular, aortic root and selective coronary angiography, 32gI/100ml, 30～60 ml once injection
Active Comparator: iopromide	Drug: iopromide coronary angiography, 370mgI/ml(0.769gIopromide/ml),5～8 ml once injection Other Names: Ultravist

Arm

Intervention/Treatment

Experimental: Iodixanol

Drug: iodixanol

coronary angiography, 32gI/100ml, 40～60 ml once injection left ventricular, aortic root and selective coronary angiography, 32gI/100ml, 30～60 ml once injection

Active Comparator: iopromide

Drug: iopromide

coronary angiography, 370mgI/ml(0.769gIopromide/ml),5～8 ml once injection

Other Names:

Ultravist

Outcome Measures

Primary Outcome Measures

to evaluate the change in Glomerular Filtration Rate levels by Estimated Glomerular Filtration Rate [days 3 and 7]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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)

Exclusion Criteria:

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) ]
Uncontrolled condition of hyperthyroidism
pregnancy or lactation
Is planned to receive the drugs without permission in this protocol
Participating in another intervention research study in last 3 months
legally incapacitated or limitations
Any other conditions not suitable to be enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anhui Provincial Hospital	Hefei	Anhui	China	230001
2	Peking University First Hospital	Beijing	Beijing	China	100044
3	Fujian Medical University Union Hospital	Fuzhou	Fujian	China	350001
4	Guangdong Academy Of Medical Sciences Guangdong General Hospital	Guangzhou	Guangdong	China	510080
5	The First Affiliated Hospital Of Guangxi Medical University	Nanning	Guangxi	China	530021
6	The People's Hospital Of Hebei Province	Shijiazhuang	Hebei	China	050051
7	Henan Provincial People's Hospital	Luoyang	Henan	China	450000
8	The Second Affiliated Hospital To Nanchang University	Nanchang	Jiangxi	China	330006
9	The People's Hospital Of Liaoning Province	Shenyang	Liaoning	China	110016
10	The Affiliated Hospital Of Medical College Qingdao University	Qingdao	Shandong	China	266003
11	Shanxi Cardiovascular Hospital	Taiyuan	Shanxi	China	030024
12	Peking University People's Hospital	Beijing		China	100044
13	Pla Navy General Hospital	Beijing		China	100048
14	The Central Hospital Of China Aerospace Corporation	Beijing		China	100049
15	Chinese PLA General Hospital	Beijing		China	100853
16	Xinqiao Hospital, Third Military Medical University	Chongqing		China	400037
17	Renji Hospital ，Shanghai Jiao Tong University School Of Medicine	Shanghai		China	200001
18	Shanghai Chest Hospital Affiliated To Shanghai Jiaotong University	Shanghai		China	200030
19	Shanghai First People's Hospital	Shanghai		China	200080