contrast-induced nephropathy, acute renal failure
Conditions
Interventions
Trade Name: Accupaque
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: IOHEXOL
CAS Number: 66108-95-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concent
Sponsors
University of Cologne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. men and women 18 years of age or older 2. caucasian origin 3. scheduled coronary angiography 4. indication for coronary angiography is determined by the referring physician 5. Patient and/or legal guardian must be willing and able to give written informed consent 6. at least one of the following risk factors: •serumkreatinine > 1,1 mg/dl in male patients or serumkreatinin > 0,9 mg/dl in female patients •Diabetes mellitus •peripher arteriovascular disease •heartfailure with NYHA 3-4 or ejection fraction = 50% •age over 70 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: 1. End-stage renal disease (patient on dialysis); 2. Indwelling kidney transplant; 3. Malnutrition (BMI 35 kg/m2 or body weight > 120 kg; 6. diet within the previous 4 weeks; 7. Inappetence ; 8. Weight loss > 1 kg within the previous 2 weeks, if not explained by use of diuretics; 09. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The intention of this trial is to investigate, if a short-term calorie restriction before contrast agent administration can prevent contrast induced nephropathy.;Primary end point(s): Analysis of the increase of serum creatinine 48h after the onset of coronary intervention (contrast agent exposition).;Timepoint(s) of evaluation of this end point: 48 hours after intervention;Secondary Objective: Analysis of the increase of serum creatinine 24h after the onset of coronary intervention (contrast agent exposition); Neutrophil gelatinase-associated lipocalin (NGAL in µg/l) in urine 24h after the onset of coronary intervention (contrast agent exposition); Cystatin C in plasma (mg/l) 24h after the onset of coronary intervention (contrast agent exposition) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Analysis of the increase of serum creatinine 24h after the onset of coronary intervention (contrast agent exposition); Neutrophil gelatinase-associated lipocalin (NGAL in µg/l) in urine 24h after the onset of coronary intervention (contrast agent exposition); Cystatin C in plasma (mg/l) 24h after the onset of coronary intervention (contrast agent exposition);Timepoint(s) of evaluation of this end point: 24 hours after intervention | — |
Countries
Germany
Contacts
Public ContactClinic II Internal Medicine
University Hospital of Cologne
Outcome results
None listed