Effect of a preoperative calorie restriction on renal function after cardiac surgery in patients at risk

Not Applicable

• Conditions: N17.9; Acute renal failure, unspecified

• Registration Number: DRKS00003355
• Lead Sponsor: niversität zu Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-23
• Study Completion: 2015-02-01
• Results First Posted: 2018-03-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 82

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

1.End-stage renal disease (patient on dialysis)
2.Indwelling kidney transplant
3.Malnutrition (BMI < 18,5 kg/m2)
4.Body weight< 46 kg in male
< 51 kg in female
5.BMI > 35 kg/m2 or body weight > 120 kg
6.catabolic state (serum albumine < 25 g/l)
7.diet within the previous 4 weeks
8.Inappetence
9.Weight loss > 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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).