Condition category
Respiratory
Date applied
06/05/2009
Date assigned
03/07/2009
Last edited
03/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Adamzik

ORCID ID

Contact details

Klinik fur Anasthesiologie und Intensivmedizin
Hufelandstrasse 55
Essen
45122
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Detection of novel genetic polymorphisms (single nucleotide polymorphisms [SNPs]) within the aquaporins 1 and 5: an observational single-centre study

Acronym

Study hypothesis

We hypothesised that single nucleotide polymorphisms (SNPs) within the aquaporins 1 and 5 contribute to the phenotypic variability of acute respiratory distress syndrome (ARDS), sepsis or bronchial asthma.

Ethics approval

Local ethics committee (Vorsitzender der Ethikkommission, Institut für Pharmakologie, Universitätsklinikum Essen) approved on the 9th December 2002 (ref: 01-97-1697, 05-2776, 06-3078, 07-3313)

Study design

Observational single-centre case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Aquaporines, cell migration and inflammation

Intervention

The following analyses will be performed on each participant:
1. Deoxyribonucleic acid (DNA) extraction from rest material of the routine diagnostic, e.g., saliva, urine or blood
2. Identification of novel DNA polymorphisms through sequencing polymerase chain reaction (PCR) products of the AQP1 and 5 promoter. The method of "slowdown PCR" should be used to amplify promoter fragments with extremely high GC content (greater than 85%).
3. Determination of transcriptional activity of haplotypes by reporter assays in different cell lines
4. Haplotype-dependent analysis of radiation and chemotherapeutics on cell proliferation in cell systems
5. Haplotype-dependent analysis of messenger ribonucleic acid (mRNA) level by quantitative real time PCR
6. Haplotype-dependent analysis of protein level by Western Blot
7. Haplotype-dependent analysis of cell migration
8. Haplotype-dependent analysis of transcription factors which bind to the polymorphic regions by electrophoretic mobility shift assay (EMSA)
9. Genotyping of ARDS, sepsis, bronchial asthma patients and healthy caucasian subjects by restriction fragment length polymorphism (RFLP) and pyrosequencing and haplotype-dependent analysis of survival and disease course using SPSS and GraphPad Prism software

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Detection of SNPs wthin the Aqquaporin 1 and 5 gen which contribute to the phenotypic variability of ARDS, sepsis and bronchial asthma, measured at 30 day survival and 100 day survival

Secondary outcome measures

Analysis of survival, disease course and rehabilitation, measured at 30 day survival and 100 day survival

Overall trial start date

01/01/2005

Overall trial end date

01/01/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Acute respiratory distress syndrome:
1.1. Timing: acute onset
1.2. Oxygenation: partial pressure of oxygen in arterial blood (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 200 mmHg (regardless of positive end expiratory pressure [PEEP])
1.3. Chest radiograph: bilateral infiltrates seen on frontal chest radiograph
1.4. Pulmonary artery wedge (PAW): less than 18 mmHg when measured or no clinical evidence of left atrial hypertension
2. Lung function testing with body plethysmography-revealed bronchial asthma
3. Patients with severe sepsis
4. Aged 18 to 70 years, both genders

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 healthy caucasian subjects, 150 ARDS-, 200 sepsis- and 100 bronchial asthma patients

Participant exclusion criteria

No written informed consent is obtained

Recruitment start date

01/01/2005

Recruitment end date

01/01/2011

Locations

Countries of recruitment

Germany

Trial participating centre

Klinik fur Anasthesiologie und Intensivmedizin
Essen
45122
Germany

Sponsor information

Organisation

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)

Sponsor details

c/o Dr Simone Mueller
Lebenswissenschaften 1
Geschaftsstelle
Kennedyallee 40
Bonn
53170
Germany

Sponsor type

Research council

Website

http://www.dfg.de/

Funders

Funder type

Research council

Funder name

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) - pending as of 06/05/2009

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18846354

Publication citations

  1. Results

    Adamzik M, Frey UH, Bitzer K, Jakob H, Baba HA, Schmieder RE, Schneider MP, Heusch G, Peters J, Siffert W, A novel-1364A/C aquaporin 5 gene promoter polymorphism influences the responses to salt loading of the renin-angiotensin-aldosterone system and of blood pressure in young healthy men., Basic Res. Cardiol., 2008, 103, 6, 598-610, doi: 10.1007/s00395-008-0750-z.

Additional files

Editorial Notes