Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00006368

Trial Description

start of 1:1-Block title

Title

Effect of a Preoperative Calorie Restriction on Renal Function After Cardiac Surgery

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

CR_KCH

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The aim of this study is to assess the effect of a diet prior to cardiac surgery on the
common postoperative decline of renal function. Until now, there is no known drug or
procedure to preserve the kidneys from this impairment. Patients with a known kidney disease
are especially at risk. A potential beneficial effect of a diet prior to surgery has been
shown in investigations in mammals, therefore this study will investigate if a preoperative
diet in patients with known kidney disease and scheduled heart surgery can attenuate or
prevent a postoperative loss of kidney function.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Patients with cardiothoracic surgery are at risk for postoperative acute renal failure which
is associated with significant morbidity and mortality. There is no drug or procedure known
to prevent this loss of renal function. Experimental data suggests, that a preoperative
caloric restriction might provide kidney protection in this context. This clinical trial
investigates if this phenomenon is also applicable in humans. Patients with a increased risk
for a postoperative 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 -7 until day -1 (included) pre-surgery (day 0 corresponds to day
of surgery). Patients of the control group receive alimentation ad libitum.

Primary objective is the increase of serum creatinine in mg/dl 24 h after induction of
ischemia ("cross clamping") in comparison to baseline value obtained in the morning of the
day of surgery (day 0) in order to analyse if a preoperative calorie restriction as a
preventive strategy leads to a attenuation of postoperative kidney injury. Hypothesis: A
seven day calorie restriction reduces the increase of serum creatinine after cardiac surgery
in patients with known chronic kidney disease.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006368
  •   2014/08/22
  •   2012/01/30
  •   yes
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT01534364  (ClinicalTrials.gov)
  •   001  (University of Cologne)
  •   00003355 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Acute Renal Failure
  •   N17 -  Acute renal failure
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Other: calorie restriction
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   No treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- The Increase of serum creatinine in mg/dl 24 h after induction of ischemia ("cross clamping") in comparison to baseline value obtained in the morning of the day of surgery (day 0).; time frame: baseline and 24 hours after induction of ischemia

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Urine Neutrophil-Gelatinase associated Lipocalin (NGAL in µg/l) 8h after induction of ischemia in comparison to baseline value obtained in the morning of the day of surgery (day 0).; time frame: baseline and 8 hours after induction of ischemia
- C-reactive Protein (CRP) 24h after induction of ischemia; time frame: baseline and 24 h after induction of ischemia
- Leucocyte count 24h after induction of ischemia; time frame: baseline and 24h after induction of ischemia
- Creatinkinase (CK) 24h after induction of ischemia; time frame: baseline and 24 h after induction of ischemia
- Troponin T 24h after induction of ischemia; time frame: baseline and 24 h after induction of ischemia
- Lactate dehydrogenase 24h after induction of ischemia; time frame: baseline and 24 h after ischemia
- N-terminal pro brain natriuretic peptide (NT-ProBNP) 24h after induction of ischemia; time frame: baseline and 24 h after ischemia
- Serum lactate 24h after induction of ischemia; time frame: baseline and 24 hours after ischemia
- Maximum increase of serum creatinine within the first 48 h after induction of ischemia; time frame: baseline and 48 hours after ischemia
- Necessity of renal replacement therapy during hospital stay; time frame: pt will be followed for the duration of hospital stay, an expected average of 10 days
- In-hospital mortality; time frame: pt will be followed for the duration of hospital stay, an expected average of 10 days
- Time until fit for discharge; time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
- Length of hospital stay; time frame: Pt will be followed for the duration of hospital stay an expected average of 10 days
- Echocardiographic estimated left-ventricular ejection fraction as per file, if assessed postoperatively; time frame: baseline and postoperatively, expected within 10 days after operation
- Occurrence of acute renal failure in accordance with KDIGO I, II, III; time frame: Patients will be followed during hospital stay, an expected average of 10 days

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2012/01/31
  •   82
  •   [---]*
  •   [---]*
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

1. Men and women 18 years of age or older

2. Caucasian origin

3. Scheduled cardiothoracic operation with employment of cardio-pulmonary bypass and a
lead time of 11 days minimum.

4. Indication for cardiac surgery is determined by the cardiothoracic specialist

5. Patient and/or legal guardian must be willing and able to give written informed
consent

6. one of the following risk factors:

1. serum creatinine >1,1 mg/dl in male and > 0,9 mg/dl in female

2. type 2 diabetes

3. peripheral artery occlusive disease

4. heart failure with NYHA III-IV (ejection fraction < 50 %)

5. combined CABG and heart valve surgery

6. further surgery after CABG or heart valve surgery

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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 and < 51 kg in female

5. BMI > 35 kg/m2 or body weight > 120 kg

6. Catabolic state (serum albumine < 25 g/l)

7. Diet within the previous 4 weeks

8. Inappetence

9. Weight loss > 1 kg within the previous 2 weeks, if not explained by use of diuretics

10. Hospital stay during the last 7 days prior to cardiac surgery

11. Consuming underlying disease

12. Uncontrolled local or systemic infection

13. Contraindication for enteral nutrition.

14. Known allergy against or incompatibility with ingredients of the employed
formula-diet

15. Pregnancy or breast feeding

16. Participation in other interventional clinical trials.

17. Missing safe method of contraception or missing occurence of menopause (in female)

18. Professional or private relationship between subject and the investigators or
dependence on the investigators.

19. Placement in an institution based on official orders.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • University of Cologne
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Fresenius Kabi
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • University of Cologne
    • Volker Burst, MD 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Volker Burst, MD 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.