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The Acetylcysteine for Contrast-Induced Nephropathy Trial (ACT)

Primary Purpose

Acute Kidney Failure

Status

Completed

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Acetylcysteine

Placebo

About this trial

This is an interventional prevention trial for Acute Kidney Failure focused on measuring acetylcysteine, contrast-induced nephropathy, angiography, angioplasty with or without Stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

At least one of the following criteria:

Aged more than 70 years-old
Chronic renal failure (defined as serum creatinine higher than 1.5mg/dL within the last 3 months)
Diabetes mellitus
Congestive heart failure or ventricular disfunction (left ventricular ejection fraction less than 0.45)
Shock or intra-aortic balloon pump use
Urgency or emergency procedures

Exclusion Criteria:

Pregnant women, breastfeeding or aged below 45 years-old and with no efficacious contraceptive methods.
Patients in dialysis
Previous inclusion in this trial
Patient refusal to informed consent
Pacientes com Infarto Agudo do Miocárdio com supradesnivelamento do segmento S-T nos quais não seja possível administrar o protocolo de hidratação pré e pós-procedimento.

Sites / Locations

Hospital do Coração

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acetylcysteine

Control

Arm Description

Outcomes

Primary Outcome Measures

Contrast-induced nephropathy incidence

Secondary Outcome Measures

Combined outcome of total mortality, dialysis indication or basal serum creatinine duplication

Combined outcome of total mortality or dialysis indication

The individual components of the combined outcome

Full Information

NCT ID

NCT00736866

First Posted

August 14, 2008

Last Updated

July 8, 2010

Sponsor

Hospital do Coracao

Collaborators

Medley Pharmaceutical Industry SA

1. Study Identification

Unique Protocol Identification Number

NCT00736866

Brief Title

The Acetylcysteine for Contrast-Induced Nephropathy Trial

Acronym

ACT

Official Title

A Pragmatic Randomized Clinical Trial Evaluating the Effect of Acetylcysteine for Contrast-induced Nephropathy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital do Coracao

Collaborators

Medley Pharmaceutical Industry SA

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of acetylcysteine compared to placebo for the contrast-induced nephropathy prevention, between 48 and 96 hours after procedures that use contrast. Contrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Failure

Keywords

acetylcysteine, contrast-induced nephropathy, angiography, angioplasty with or without Stent

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acetylcysteine

Arm Type

Experimental

Arm Title

Control

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Acetylcysteine

Intervention Description

Acetylcysteine: 1200 mg every 12 hours for a total of 4 doses. Treatment is to be started 12 hours before angiography, that is, two doses should be administered before it. When this is not achievable, at least one dose should be administered before angiography.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo of Acetylcysteine: every 12 hours PO, for a total of 4 doses. Treatment is to be started 12 hours before angiography, that is, two doses should be administered before it. When this is not achievable, at least one dose should be administered before angiography.

Primary Outcome Measure Information:

Title

Contrast-induced nephropathy incidence

Time Frame

between 48 and 96 hours after angiographic procedures

Secondary Outcome Measure Information:

Title

Combined outcome of total mortality, dialysis indication or basal serum creatinine duplication

Time Frame

within 30 days

Title

Combined outcome of total mortality or dialysis indication

Time Frame

within 30 days

Title

The individual components of the combined outcome

Time Frame

within 30 dias

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: At least one of the following criteria: Aged more than 70 years-old Chronic renal failure (defined as serum creatinine higher than 1.5mg/dL within the last 3 months) Diabetes mellitus Congestive heart failure or ventricular disfunction (left ventricular ejection fraction less than 0.45) Shock or intra-aortic balloon pump use Urgency or emergency procedures Exclusion Criteria: Pregnant women, breastfeeding or aged below 45 years-old and with no efficacious contraceptive methods. Patients in dialysis Previous inclusion in this trial Patient refusal to informed consent Pacientes com Infarto Agudo do Miocárdio com supradesnivelamento do segmento S-T nos quais não seja possível administrar o protocolo de hidratação pré e pós-procedimento.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eduardo Sousa, PhD

Organizational Affiliation

Hospital do Coracao

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital do Coração

City

Sao Paulo

ZIP/Postal Code

04004030

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

23572490

Citation

Berwanger O, Cavalcanti AB, Sousa AM, Buehler A, Castello-Junior HJ, Cantarelli MJ, Mangione JA, Bergo RR, Sao Thiago LE, Nunes PM, da Motta PA, Kodama A, Victor E, Carvalho VO, Sousa JE; Acetylcysteine for Contrast-Induced Nephropathy Trial Investigators. Acetylcysteine for the prevention of renal outcomes in patients with diabetes mellitus undergoing coronary and peripheral vascular angiography: a substudy of the acetylcysteine for contrast-induced nephropathy trial. Circ Cardiovasc Interv. 2013 Apr;6(2):139-45. doi: 10.1161/CIRCINTERVENTIONS.112.000149. Epub 2013 Apr 9.

Results Reference

derived

PubMed Identifier

21859972

Citation

ACT Investigators. Acetylcysteine for prevention of renal outcomes in patients undergoing coronary and peripheral vascular angiography: main results from the randomized Acetylcysteine for Contrast-induced nephropathy Trial (ACT). Circulation. 2011 Sep 13;124(11):1250-9. doi: 10.1161/CIRCULATIONAHA.111.038943. Epub 2011 Aug 22.

Results Reference

derived

PubMed Identifier

19497091

Citation

ACT Trial Investigators. Rationale, design, and baseline characteristics of the Acetylcystein for Contrast-Induced nephropaThy (ACT) Trial: a pragmatic randomized controlled trial to evaluate the efficacy of acetylcysteine for the prevention of contrast-induced nephropathy. Trials. 2009 Jun 4;10:38. doi: 10.1186/1745-6215-10-38.

Results Reference

derived

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The Acetylcysteine for Contrast-Induced Nephropathy Trial

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