By conducting this trial, it will be investigated if a short-term calorie restriction can protect the kidney from the negative influence of contrast agent.

Phase 1

• Conditions: contrast-induced nephropathy, acute renal failure; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2012-003696-18-DE
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-01
• Last Update Posted: 21 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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