NCT00316576

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

April 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2006

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

January 17, 2008

Status Verified

January 1, 2008

First QC Date

April 19, 2006

Last Update Submit

January 16, 2008

Conditions

Kidney Failure, AcuteCritical Illness

Keywords

Kidney failure, AcuteGenetic PolymorphismAngiotensin-converting enzyme

Outcome Measures

Primary Outcomes (1)

  • Incidence of ARF

    During ICU stay

Secondary Outcomes (1)

  • Mortality

    ICU and Hospital mortality

Interventions

Blood sampling for PCRPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients admitted to ICU fore more than 48 hours

You may qualify if:

  • Age \> 18 yrs
  • ICU stay \> 48 hours

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Intensive care Unit; Caen University Hospital

Caen, 14000, France

Location

Related Publications (1)

  • 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.

    PMID: 19020433DERIVED

MeSH Terms

Conditions

Acute Kidney InjuryCritical Illness

Interventions

Blood Specimen CollectionPolymerase Chain Reaction

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesNucleic Acid Amplification TechniquesGenetic Techniques

Study Officials

  • Damien du Cheyron, MD

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 19, 2006

First Posted

April 21, 2006

Study Start

May 1, 2006

Study Completion

November 1, 2006

Last Updated

January 17, 2008

Record last verified: 2008-01

Locations

FR(1)