Trial document




drksid header

  DRKS00000666

Trial Description

start of 1:1-Block title

Title

Effect of remote preconditioning on contrast medium induced renal failure

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

Trial Acronym

RenProStudy (Renal Protection Study)

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

Patients with impaired renal function are at high risk when coronary angiography (CA) with contrast medium is performed. Contrast medium induced renal failure (CIN) is a serious complication after CA.
Remote preconditioning (RPC) has been shown to be useful in reducing ischemic damage in several organ systems.
The clinical perspective is now to examine if RPC before CA can prevent CIN.
Effect measure will be CIN and impairment of renal function.

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

Brief Summary in Scientific Language

Background
Renal failure is associated with high morbidity and mortality. Patients with already reduced renal function are at high risk when contrast medium is administered. During invasive coronary angiography contrast medium is used which may worsen renal function. Strategies for prevention of the contrast medium induced renal failure are very rare. The contrast medium induced renal failure is similar to ischemic injury. Therefore remote preconditioning before contrast medium use might be useful in patients with reduced renal function.
Methods
Patients will be randomly assigned to receive either standard therapy alone or plus RPC. For RPC patients underwent a procedure with intermittent arm ischemia through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff.
Renal function will be compared in the standard therapy group vs. standard therapy+RPC. Markers for renal function are serum creatinin, cystatin c and urin neutrophil gelatinase-associated lipocalin.
Purpose
To assess whether RPC can protect from contrast medium induced renal failure.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000666
  •   2011/01/04
  •   [---]*
  •   yes
  •   Approved
  •   10-311, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1118-8098 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I25 -  Chronic ischaemic heart disease
  •   N18 -  Chronic renal failure
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Remote preconditioning: before coronary angiogram, assigned patients will prepared for the contrast medium use as:
    intermittent arm ischaemia through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff will be performed.
  •   No intervention
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   No treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Incidence of contrast medium induced nephropathy, defined as increment of serum-creatinin of 0.5 mg/dl or of at least 25% in 48 hours after contrast medium intake.

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

Secondary Outcome

Changes of neutrophil gelatinase-associated lipocalin (NGAL), serum creatinin and cystatine after coronary angiogram.

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

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2011/01/06
  •   100
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

1. GFR (MDRD formula) < 60 ml/min/1.73 m²
and/or serum creatinine > 1.4 mg/dl
2. Elective invasive coronary angiogram

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

Exclusion Criteria

terminal renal failure with need of hemodialyses

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik III für Innere Medizin Uniklinik Köln
    • Mr.  PD Dr.   Fikret  Er 
    • Kerpener Str. 62
    • 50924  Köln
    • 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 scientific-contact
    • Klinik III für Innere Medizin Uniklinik Köln
    • Mr.  PD Dr.   Fikret  Er 
    • Kerpener Str. 62
    • 50924  Köln
    • 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
    • Klinik III für Innere Medizin Uniklinik Köln
    • Mr.  PD Dr.   Fikret  Er 
    • Kerpener Str. 62
    • 50924  Köln
    • 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
    • Klinik III für Innere Medizin Uniklinik Köln
    • Mr.  PD Dr.   Fikret  Er 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2011/05/30
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Circulation. 2012 Jul 17;126(3):296-303.
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.