Angiotensin-Converting Enzyme Polymorphism and Acute Rena... | NCT00316576

Studies
Angiotensin-Converting Enzyme Polymorphism and Acute Renal Failure (ECAREA)

NCT00316576

Sponsor

University Hospital, Caen

Status

Terminated

Last Update Posted

Jan 17, 2008Estimated

Enrollment

160Estimated

Phase

Not provided

Conditions

Kidney Failure, Acute
Critical Illness

Interventions

Blood sampling for PCR

Countries

France

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

Jan 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was stopped on november 2006 after inclusion was fulfilled

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Not provided

Completion Date

Nov 2006Actual

First Submitted Date

Apr 19, 2006

First Submission Date that Met QC Criteria

Apr 19, 2006

First Posted Date

Apr 21, 2006Estimated

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

Jan 16, 2008

Last Update Posted Date

Jan 17, 2008Estimated

Description Module

Brief Summary

Associations between angiotensin-converting enzyme gene polymorphism and occurrence and outcome of ARDS, and with respiratory complications post cardiopulmonary bypass have already been demonstrated. Based on physiological effects of angiotensin II, we hypothesized that the I allele of the angiotensin-converting enzyme Insertion/Deletion polymorphism may be associated with a higher risk of acute renal failure in critically ill patients.

Detailed Description

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Name	Type	Description	Arm Group Labels	Other Names
Blood sampling for PCR	Procedure

Measure	Description	Time Frame
Incidence of ARF		During ICU stay

Measure	Description	Time Frame
Mortality		ICU and Hospital mortality

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 yrs
ICU stay > 48 hours

Exclusion Criteria:

Age < 18 yrs
Creatinine > 180 µmol/L
Absence of consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients admitted to ICU fore more than 48 hours

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Damien du Cheyron, MD	University Hospital, Caen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Intensive care Unit; Caen University Hospital		Caen		14000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19020433	Derived	du Cheyron D, Fradin S, Ramakers M, Terzi N, Guillotin D, Bouchet B, Daubin C, Charbonneau P. Angiotensin converting enzyme insertion/deletion genetic polymorphism: its impact on renal function in critically ill patients. Crit Care Med. 2008 Dec;36(12):3178-83. doi: 10.1097/CCM.0b013e318186a299.

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

ID	Term
D001800	Blood Specimen Collection
D016133	Polymerase Chain Reaction

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

ID	Term
D058186	Acute Kidney Injury
D016638	Critical Illness