Effect of a preinterventional calorie restriction on renal function after contrast agent exposition in patients at risk.

Phase 4

• Conditions: N17; Acute renal failure

• Registration Number: DRKS00004361
• Lead Sponsor: niversität zu Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-23
• Study Completion: 2016-10-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

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

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of the increment of serum creatinine 48h after the onset of coronary intervention (contrast agent exposition).

Secondary Outcome Measures

Name	Time	Method
Analysis of the increment 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)