N-Acetyl Cystein and Contrast Nephropathy | NCT01820195

Studies
N-Acetyl Cystein and Contrast Nephropathy

NCT01820195

Sponsor

Imam Khomeini Hospital

Status

Unknown status

Last Update Posted

Mar 28, 2013Estimated

Enrollment

549Estimated

Phase

Phase 3

Conditions

Chronic Kidney Disease Stage 2
Radiographic Contrast Agent Nephropathy

Interventions

Oral N-Acetyl Cystein
IV N-Acetyl Cystein
Placebo group

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Aug 2014Estimated

Completion Date

Nov 2014Estimated

First Submitted Date

Mar 25, 2013

First Submission Date that Met QC Criteria

Mar 27, 2013

First Posted Date

Mar 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2013

Last Update Posted Date

Mar 28, 2013Estimated

Name	Class
Tehran Heart Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

There are many controversies about the role of N-Acetyl Cystein in preventing of contrast nephropathy. These contradictory results may be due to different criteria for patients' selection, different end points, different type and dose of N-Acetyl Cystein administration and finally different prophylactic measures other than N-Acetyl Cystein. The investigators try to enroll a double blind double dummy study with a good power to compare the effect of this drug both in the form of oral and intravenous against the placebo in preventing the contrast nephropathy in the patients whom undergo coronary angiography/angioplasty.

Detailed Description

Contrast Nephropathy is the third cause of acute kidney injury in hospitalized patients. The morbidity and mortality of this disorder is considerable. There is no treatment for this condition and all measures should be taken into account to prevent this complication. Among the all prophylactic measures hydration and the dose ant type of contrast are the only factors that have been proved to be effective in preventing contrast nephropathy. N-Acetyl Cystein is an antioxidant agents that may be effective in different aspects of medicine, but it,s use in this condition is controversial. While some studies showed it is effective in prevention of contrast nephropathy, others showed no benefit. Different studies used different dose and route of administration. So more clinical trials with good power are needed to compare different oral Vs IV administration of the drug in a randomized double blinded clinical trial. In this study we allocate the eligible patients with chronic kidney diseases stages 2 to 4 to three groups. Oral N-Acetyl Cystein group, IV N-Acetyl Cystein group, placebo group. All group will be matched according to stages of chronic kidney diseases, diabetes, anemia, heart failure, age and sex.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

549Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intravenous N Acetyl Cystein	Active Comparator	1200 mg IV N- Acetyl Cystein half an hour before contrast administration. This group will also take oral placebo	Drug: IV N-Acetyl Cystein
Placebo	Placebo Comparator	Patients on both oral placebo and IV placebo just like patients on oral and IV N-acetyl cystein groups in regard of dose and timing.	Drug: Placebo group
Oral N Acetyl Cystein	Active Comparator	Patients on 600 mg oral N-Acetyl Cystein bid started at the day before contrast exposure and continue until the next day of contrast exposure.These patients will also take IV placebo	Drug: Oral N-Acetyl Cystein

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral N-Acetyl Cystein	Drug	Oral N-Acetyl Cystein 600 mg bid started the day before contrast administration and continue the day after exposure to contrast	Oral N Acetyl Cystein

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Increase in serum creatinine more than 25% of baseline		24 hours, 48 hours after exposure to contrast media

Secondary Outcomes

Measure	Description	Time Frame
Increase in serum creatinine more than 25% of baseline		The 5th day after exposure to contrast media

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age more than 18
chronic Kidney disease stage 2-4
use of nephrotoxins in last week leading to angiography

Exclusion Criteria:

Acute kidney injury
concomitant use of other nephrotoxins
need of repeated imaging with contrast in five days after the first surgery
need for surgery in next five day after the contrast exposure
need of using nephrotoxins in next five days after contrast exposure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohammad R Khatami, MD	Contact			khatamis@sina.tums.ac.ir
Ebrahim Kassaeian, MD	Contact

Overall Officials

Name	Affiliation	Role
Mohammad R Khatami, MD	Nephrology Research Center	Study Chair
Ebrahin Kassaian, MD	Tehran Heart Center	Principal Investigator
Mojtaba Salarifar, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tehran Heart Center	Recruiting	Tehran			Iran

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

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Browse Branches

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