Effect of a Pre-interventional Diet on Renal Function After Administration of Contrast Agent in Patients at Risk

Renal Failure Chronic Contrast Induced Clinical Trial

— CR_KMN  

Official title:

Phase 4 Study of Effect of a Pre-interventional Calorie Restriction on Renal Function After Administration of Contrast Agent in Patients at Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01879839
• Other study ID #: uni-koeln-1547
• Secondary ID: 2012-003696-18
• Status: Completed
• Phase: Phase 4
• Start date: July 2013
• Est. completion date: December 2016

Study information

• Verified date: August 2019
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess the effect of a diet prior to administration of contrast agent in terms of a preventive procedure which leads to an attenuation of the contrast-induced nephropathy (CIN).

Patients with a known kidney disease are especially at risk. A potential beneficial effect of a diet prior to intervention has been shown in investigations in mammals, therefore this study will investigate if a pre-interventional diet in patients with known kidney disease and scheduled contrast agent examination can attenuate or prevent a post-interventional loss of kidney function.

Description:

Patients with contrast agent examinations are at risk for contrast-induced nephropathy (CIN) and in succession acute renal failure which is associated with significant morbidity and mortality. None of the currently used preventive procedures show a benefit in terms of a CIN-prevention.

Experimental data suggests, that a pre-interventional caloric restriction might provide kidney protection in this context. This clinical trial investigates if this phenomenon is also applicable in humans. Patients with increased risk for a post-interventional renal failure due to known chronic kidney disease are randomized in 2 groups. Patients of the diet group receive a calorie restriction to 60% of the calculated daily energy rate from day -4 until day -1 (included) pre-intervention (day 0 corresponds to day of intervention). Patients of the control group receive alimentation ad libitum.

Primary objective is the increase of serum creatinine in mg/dl 48 h after begin of intervention in comparison to baseline value obtained in the morning of the day of intervention (day 0) in order to analyse if a pre-interventional calorie restriction as a preventive strategy leads to an attenuation of post-interventioal kidney injury.

Hypothesis: A four day calorie restriction reduces the increase of serum creatinine after administration of contrast agent in patients with known chronic kidney disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• serum creatinine > 1,1 mg/dl in male patients or serum creatinin > 0,9 mg/dl in female patients

• Type 2 diabetes

• 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

9. 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.

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Failure Chronic Contrast Induced
• Renal Insufficiency

Intervention

Dietary Supplement:
• Diet
Patients receive special diet 4 days prior to contrast-agent administration.

Locations

Country	Name	City	State
Germany	University Hospital of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Occurrence of CIN (contrast-agent induced nephropathy) with rise of serum creatinine about = 0,5 mg/dl or = 25% of initial value with 48 hours.		Baseline to 48 hours.
Other	Occurrence of acute renal failure corresponding KDIGO I, II, III		Baseline to 4 weeks
Other	Necessity of dialysis up to 4 weeks after coronary intervention.		Baseline to 4 weeks.
Other	Mortality at timepoint 4 weeks after coronary intervention.		Baseline to 4 weeks.
Other	Hospitalization up to 4 weeks after coronary intervention.		Baseline to 4 weeks.
Other	Urea (mg/dl), white blood cells (/µl) LDH (U/l), CRP (mg/l), CK (U/l), CK-MB (U/l und %) at timepoint 24 and 48 hours after coronary angiography		Baseline to 24 and 48 hours
Primary	Rise of serum creatinine in mg/dl 48 hours after begin of coronary intervention (contrast agent administration)		Baseline to 48 hours
Secondary	Rise of serum creatinine in mg/dl 24 hours after begin of coronary intervention.		Baseline to 24 hours
Secondary	Neutrophile-Gelatinase associated Lipocaline (NGAL in µg/l) in urine 24 hours after begin of coronary intervention.		Baseline to 24 hours
Secondary	Cystatin C in Plasma (mg/l) 24 hours after begin of coronary intervention.		Baseline to 24 hours