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

NCT01879839 | Completed Phase 4 DMC

• 2 other identifiers: uni-koeln-15472012-003696-18
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Failure Chronic Contrast Induced

Outcome Measures

Primary Outcomes (1)

• Rise of serum creatinine in mg/dl 48 hours after begin of coronary intervention (contrast agent administration)

  Baseline to 48 hours

Secondary Outcomes (3)

• Rise of serum creatinine in mg/dl 24 hours after begin of coronary intervention.

  Baseline to 24 hours

• Neutrophile-Gelatinase associated Lipocaline (NGAL in µg/l) in urine 24 hours after begin of coronary intervention.

  Baseline to 24 hours

• Cystatin C in Plasma (mg/l) 24 hours after begin of coronary intervention.

  Baseline to 24 hours

Other Outcomes (6)

• 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.

• Occurrence of acute renal failure corresponding KDIGO I, II, III

  Baseline to 4 weeks

• Necessity of dialysis up to 4 weeks after coronary intervention.

  Baseline to 4 weeks.

Study Arms (2)

Control Group

NO INTERVENTION

Patients who don't follow a special diet.

Diet Group

OTHER

Patients who subsist on a special diet.

Dietary Supplement: Diet

Interventions

Diet DIETARY_SUPPLEMENT

Patients receive special diet 4 days prior to contrast-agent administration.

Diet Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women 18 years of age or older
• caucasian origin
• scheduled coronary angiography
• indication for coronary angiography is determined by the referring physician
• Patient and/or legal guardian must be willing and able to give written informed consent
• 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

You may not qualify if:

• End-stage renal disease (patient on dialysis)
• Indwelling kidney transplant
• Malnutrition (BMI \< 18,5 kg/m2)
• Body weight \< 46 kg in male, \< 51 kg in female
• BMI \> 35 kg/m2 or body weight \> 120 kg
• diet within the previous 4 weeks
• Inappetence
• Weight loss \> 1 kg within the previous 2 weeks, if not explained by use of diuretics
• 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.

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University Hospital of Cologne

Cologne, 50937, Germany

Location

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Volker Burst, MD

  University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: One arm with controlled diet, second arm as control group with no diet.

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 18, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 9, 2019

Record last verified: 2019-08

Locations

DE (1)