Renal Failure Chronic Contrast InducedPhase 4CR_KMNNCT01879839
Effect of a Pre-interventional Diet on Renal Function After Administration of Contrast Agent in Patients at Risk
A Phase 4 study testing Diet in people with Renal Failure Chronic Contrast Induced, run by University of Cologne at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure Chronic Contrast Induced
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Renal Failure Chronic Contrast Induced
- Being tested
- Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietDietary supplement
Patients receive special diet 4 days prior to contrast-agent administration.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients who don't follow a special diet. |
| Diet Group | Other | Patients who subsist on a special diet. Receives: Dietary Supplement: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rise of serum creatinine in mg/dl 48 hours after begin of coronary intervention (contrast agent administration)
Measured: Baseline to 48 hours
Secondary outcomes (3)
Rise of serum creatinine in mg/dl 24 hours after begin of coronary intervention.
Measured: Baseline to 24 hours
Neutrophile-Gelatinase associated Lipocaline (NGAL in µg/l) in urine 24 hours after begin of coronary intervention.
Measured: Baseline to 24 hours
Cystatin C in Plasma (mg/l) 24 hours after begin of coronary intervention.
Measured: Baseline to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure Chronic Contrast InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One arm with controlled diet, second arm as control group with no diet.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volker Burst, University of Cologne
- Investigators
- Volker Burst, MD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879839
- Sponsor's protocol ID
- uni-koeln-1547
- Other IDs
- 2012-003696-18
- Acronym
- CR_KMN
- Status last verified
- Aug 2019
- First submitted
- 13 Jun 2013
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01879839
- Acronym / sponsor ID
- CR_KMN / uni-koeln-1547
- Conditions
- Renal Failure Chronic Contrast Induced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One arm with controlled diet, second arm as control group with no diet.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients who don't follow a special diet. |
| Diet Group | Other | Dietary Supplement: DietPatients who subsist on a special diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietPatients receive special diet 4 days prior to contrast-agent administration. | Dietary supplement | Diet Group |
Primary outcome
Rise of serum creatinine in mg/dl 48 hours after begin of coronary intervention (contrast agent administration)
Time frame: Baseline to 48 hours
3 secondary outcomes
Rise of serum creatinine in mg/dl 24 hours after begin of coronary intervention.
Time frame: Baseline to 24 hours
Neutrophile-Gelatinase associated Lipocaline (NGAL in µg/l) in urine 24 hours after begin of coronary intervention.
Time frame: Baseline to 24 hours
Cystatin C in Plasma (mg/l) 24 hours after begin of coronary intervention.
Time frame: Baseline to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Volker Burst, MD principal investigator
University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diet in people with Renal Failure Chronic Contrast Induced, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rise of serum creatinine in mg/dl 48 hours after begin of coronary intervention (contrast agent administration) (time frame: Baseline to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.