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

Primary Purpose

Renal Failure Chronic Contrast Induced

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Diet
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Failure Chronic Contrast Induced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital of Cologne

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Control Group

Diet Group

Arm Description

Patients who don't follow a special diet.

Patients who subsist on a special diet.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rise of serum creatinine in mg/dl 24 hours after begin of coronary intervention.
Neutrophile-Gelatinase associated Lipocaline (NGAL in µg/l) in urine 24 hours after begin of coronary intervention.
Cystatin C in Plasma (mg/l) 24 hours after begin of coronary intervention.

Full Information

First Posted
June 13, 2013
Last Updated
August 8, 2019
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT01879839
Brief Title
Effect of a Pre-interventional Diet on Renal Function After Administration of Contrast Agent in Patients at Risk
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure Chronic Contrast Induced

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
One arm with controlled diet, second arm as control group with no diet.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients who don't follow a special diet.
Arm Title
Diet Group
Arm Type
Other
Arm Description
Patients who subsist on a special diet.
Intervention Type
Dietary Supplement
Intervention Name(s)
Diet
Intervention Description
Patients receive special diet 4 days prior to contrast-agent administration.
Primary Outcome Measure Information:
Title
Rise of serum creatinine in mg/dl 48 hours after begin of coronary intervention (contrast agent administration)
Time Frame
Baseline to 48 hours
Secondary Outcome Measure Information:
Title
Rise of serum creatinine in mg/dl 24 hours after begin of coronary intervention.
Time Frame
Baseline to 24 hours
Title
Neutrophile-Gelatinase associated Lipocaline (NGAL in µg/l) in urine 24 hours after begin of coronary intervention.
Time Frame
Baseline to 24 hours
Title
Cystatin C in Plasma (mg/l) 24 hours after begin of coronary intervention.
Time Frame
Baseline to 24 hours
Other Pre-specified Outcome Measures:
Title
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.
Time Frame
Baseline to 48 hours.
Title
Occurrence of acute renal failure corresponding KDIGO I, II, III
Time Frame
Baseline to 4 weeks
Title
Necessity of dialysis up to 4 weeks after coronary intervention.
Time Frame
Baseline to 4 weeks.
Title
Mortality at timepoint 4 weeks after coronary intervention.
Time Frame
Baseline to 4 weeks.
Title
Hospitalization up to 4 weeks after coronary intervention.
Time Frame
Baseline to 4 weeks.
Title
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
Time Frame
Baseline to 24 and 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volker Burst, MD
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Cologne
City
Cologne
ZIP/Postal Code
50937
Country
Germany

12. IPD Sharing Statement

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

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