N17.9
Conditions
Interventions
Group 1: Calorie Restriction to 60% of the calculated daily energy rate from day -7 until day -1 (included) pre-surgery
(day 0 corresponds to day of surgery)
Group 2: Ad libitum alimentation
Sponsors
Universität zu Köln
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. men and women over 18 years 2. caucasian origin 3. scheduled cardiothoracic operation with employment of cardio-pulmonary bypass and a lead time of 11 days minimum. 4. indication for cardiac surgery is determined by the cardiothoracic specialist 5. Patient and/or legal guardian must be willing and able to give written informed consent 6. chronic renal impairment with serum creatinine > 1,5 mg/dl or creatinine > 1,1 mg/dl with at least one of the following risk factors: a. Diabetes mellitus b. pAOD c. heart failure (EF < 50%)
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. catabolic state (serum albumine 1 kg within the previous 2 weeks, if not explained by use of diuretics 10. Hospital stay during the last 7 days prior to cardiac surgery 11. Consuming underlying disease 12. Uncontrolled local or systemic infection 13. Contraindication for enteral nutrition. 14. Known allergy against or incompatibility with ingredients of the employed formula-diet 15. Pregnancy or breast feeding 16. Participation in other interventional clinical trials. 17. Missing safe method of contraception or missing occurence of menopause (in female) 18. Professional or private relationship between subject and the investigators or dependence on the investigators. 19. Placement in an institution based on official orders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is loss of renal function after cardiac surgery. The Increase of serum creatinine in mg/dl 24 h after induction of ischemia (“cross clamping”) in comparison to baseline value obtained in the morning of the day of surgery (day 0). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome is the renal tubular dysfunction. As a parameter serves the Urine Neutrophil-Gelatinase associated Lipocalin (NGAL in µg/l) 8h after induction of ischemia in comparison to baseline value obtained in the morning of the day of surgery (day 0). | — |
Countries
Germany
Contacts
Public ContactVolker Burst
Studienzentrum Med II Uniklinik Köln
Outcome results
None listed