Trial document




drksid header

  DRKS00005221

Trial Description

start of 1:1-Block title

Title

Effects of ischemic pre- and postconditioning in patients with impaired renal function and contrast-exposure

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Contrast medium in radiological examinations is used to get a higher resolution of tissue and vessels.
This contrast medium implies a risk for contrast-induced nephropathy, especially in patients with a chronic kidney disease. This damage might not be reversible. To minimize this risk, a hydration before and after contrast-exposure is done in patients with impaired kidney function. This hydration has to be done in patients with a serum-creatinine above 1,4 mg/dl.
Recent studies revealed an ischemic conditioning (IPC) as a potent procedure to attenuate kidney damage after contrast-exposure. In the follow-up time in patients with an IPC compared to patients without IPC the elevation of creatinine and cycstatin C, as markers of kidney function, were much lower.
The underlying mechanisms remains unclear.
In the following, the IPC is presented:
Ischemic conditioning is caused by 4 cycles of inflation with 50 mmHg above systolic blood pressure and deflation for 5 minutes each using blood pressure cuff.
It is performed immediately before or after contrast-exposure. Therefore we randomize the patients into two groups; one group with an IPC before and one group with an IPC after contrast-exposure to compare this effect. A third group of patients gets no ischemic conditioning. In all groups, the usually used nephroprotection by hydration will be performed in addition.
The aim of the present study is to examine the mechanisms underlying these protective functions of IPC. Therefore blood measurements and ultrasonic is performed.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The aim of the study is to investigate wether an ischemic conditioning (IPC) attenuates contrast-induced nephropathy (CIN). In this context we also want to investigate an post-exposure IPC has beneficial effects on kidney function even in patients without the opportunity to perform nephroprotection before contrast-epxosure.
The mechanisms of IPC for the attenuation of CIN remain unclear. Therefore examinations of pathophysiological pathways will be performed.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005221
  •   2013/08/15
  •   [---]*
  •   yes
  •   Approved
  •   115/13, Ethik-Kommission bei der Ärztekammer des Saarlandes
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Contrast-Induced Nephropathy
  •   N99.0 -  Postprocedural renal failure
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   preconditioning;
    ischemic conditioning caused by 4 cycles of inflation with 50 mmHg above systolic blood pressure and deflation for 5 minutes each using blood pressure cuff.
    The procedure is done BEFORE contrast exposition.
  •   postconditioning;
    ischemic conditioning caused by 4 cycles of inflation with 50 mmHg above systolic blood pressure and deflation for 5 minutes each using blood pressure cuff.
    The procedure is done AFTER contrast exposition.
  •   acute-conditioning;
    ischemic conditioning caused by 4 cycles of inflation with 50 mmHg above systolic blood pressure and deflation for 5 minutes each using blood pressure cuff.
    The procedure is usually done after contrast exposition in cases of no nephroprotection (hydration) before, for example in cases of emergency, when contrast exposition has to be done immediately.
  •   control group,
    no ischemic conditioning
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   No treatment
  •   Prevention
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

lack of kidney function loss after contrast-exposition, defined as lack of or mild decrease in renal function, characterized by an decrease of glomerular filtration rate estimated by using creatinine- and cystatin C- serum level, evaluated on three days after conditioning (dialy).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

no secundary outcome defined

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2013/08/19
  •   200
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Written consent.

Chronic kidney disease (CKD), defined as a serum-creatinin > 1,4 mg/dl.

Planned contrast-exposure and indication for nephroprotection.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

No written consent.

Patients with AV-Shunt.

Required dialysis after contrast-exposure.

Affection for haematoma.

Thrombophilia.

Stenosis or occlusive disease of vessels of the upper limb.

Systolic blood pressure > 180 mmHg.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universität des Saarlandes
    • 66421  Homburg/Saar
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Universitätsklinikum des Saarlandes
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Diagnostische und Interventionelle Radiologie
    • Mr.  Prof. Dr.  Arno  Bücker 
    • Kirrbergerstrasse
    • 66421  Homburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Univesitätsklinikum des Saarlandes, Innere Medizin IV
    • Mr.  Dr.  Stephen  Zewinger 
    • Kirrbergerstrasse
    • 66421  Homburg / Saar
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universität des Saarlandes
    • 66421  Homburg/Saar
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   06841 1623000
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.