Status:
COMPLETED
Effect of a Pre-interventional Diet on Renal Function After Administration of Contrast Agent in Patients at Risk
Lead Sponsor:
University of Cologne
Conditions:
Renal Failure Chronic Contrast Induced
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of this study is to assess the effect of a diet prior to administration of contrast agent in terms of a preventive procedure which leads to an attenuation of the contrast-induced nephropathy (...
Detailed Description
Patients with contrast agent examinations are at risk for contrast-induced nephropathy (CIN) and in succession acute renal failure which is associated with significant morbidity and mortality. None of...
Eligibility Criteria
Inclusion
- men and women 18 years of age or older
- caucasian origin
- scheduled coronary angiography
- indication for coronary angiography is determined by the referring physician
- Patient and/or legal guardian must be willing and able to give written informed consent
- at least one of the following risk factors:
- serum creatinine \> 1,1 mg/dl in male patients or serum creatinin \> 0,9 mg/dl in female patients
- Type 2 diabetes
- peripher arteriovascular disease
- heartfailure with NYHA 3-4 or ejection fraction ≤ 50%
- age over 70 years
Exclusion
- End-stage renal disease (patient on dialysis)
- Indwelling kidney transplant
- Malnutrition (BMI \< 18,5 kg/m2)
- Body weight \< 46 kg in male, \< 51 kg in female
- BMI \> 35 kg/m2 or body weight \> 120 kg
- diet within the previous 4 weeks
- Inappetence
- Weight loss \> 1 kg within the previous 2 weeks, if not explained by use of diuretics
- Consuming underlying disease 10. Uncontrolled local or systemic infection 11. Contraindication for enteral nutrition 12. Known allergy against or incompatibility with ingredients of the employed formula-diet 13. Pregnancy or breast feeding 14. Participation in other interventional clinical trials 15. Missing safe method of contraception or missing occurence of menopause (in female) 16. Professional or private relationship between subject and the investigators or dependence on the investigators 17. Placement in an institution based on official orders.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01879839
Start Date
July 1 2013
End Date
December 1 2016
Last Update
August 9 2019
Active Locations (1)
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1
University Hospital of Cologne
Cologne, Germany, 50937