Brief Title:Effect of a Preoperative Calorie Restriction on Renal Function After Cardiac Surgery (CR_KCH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Cologne
Sponsor:
Collaborator:
Fresenius Kabi
Information provided by (Responsible Party):
Volker Burst, University of Cologne
ClinicalTrials.gov Identifier:
NCT01534364
First received: January 30, 2012
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Acute Renal Failure
Other: calorie restriction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of a Preoperative Calorie Restriction on Renal Function After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • C-reactive Protein (CRP) 24h after induction of ischemia [ Time Frame: baseline and 24 h after induction of ischemia ] [ Designated as safety issue: No ]
  • Leucocyte count 24h after induction of ischemia [ Time Frame: baseline and 24h after induction of ischemia ] [ Designated as safety issue: No ]
  • Creatinkinase (CK) 24h after induction of ischemia [ Time Frame: baseline and 24 h after induction of ischemia ] [ Designated as safety issue: No ]
  • Troponin T 24h after induction of ischemia [ Time Frame: baseline and 24 h after induction of ischemia ] [ Designated as safety issue: No ]
  • Lactate dehydrogenase 24h after induction of ischemia [ Time Frame: baseline and 24 h after ischemia ] [ Designated as safety issue: No ]
  • N-terminal pro brain natriuretic peptide (NT-ProBNP) 24h after induction of ischemia [ Time Frame: baseline and 24 h after ischemia ] [ Designated as safety issue: No ]
  • Serum lactate 24h after induction of ischemia [ Time Frame: baseline and 24 hours after ischemia ] [ Designated as safety issue: No ]
  • Maximum increase of serum creatinine within the first 48 h after induction of ischemia [ Time Frame: baseline and 48 hours after ischemia ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • In-hospital mortality [ Time Frame: pt will be followed for the duration of hospital stay, an expected average of 10 days ] [ Designated as safety issue: No ]
  • Time until fit for discharge [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: Pt will be followed for the duration of hospital stay an expected average of 10 days ] [ Designated as safety issue: No ]
  • Echocardiographic estimated left-ventricular ejection fraction as per file, if assessed postoperatively [ Time Frame: baseline and postoperatively, expected within 10 days after operation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 82
Study Start Date: January 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
Ad libitum alimentation
calorie restriction
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)
Other: calorie restriction
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)
Other Name: calorie restriction with Fresubin energy fibre drink

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534364

Contacts
Contact: Volker Burst, MD +49-221-478-86285 volker.burst@uk-koeln.de
Contact: Franziska Grundmann, MD +49-221-478-86285 franziska.grundmann@uk-koeln.de

Locations
Germany
University of Cologne Recruiting
Cologne, Germany, 50937
Contact: Volker Burst, MD    0049-221-478-86285    volker.burst@uk-koeln.de   
Sub-Investigator: Franziska Grundmann, MD         
Sub-Investigator: Torsten Kubacki, MD         
Sub-Investigator: Maximilian Scherner, MD         
Sub-Investigator: Faust Michael, MD         
Sponsors and Collaborators
University of Cologne
Fresenius Kabi
Investigators
Principal Investigator: Volker Burst, MD University of Cologne
  More Information

No publications provided

Responsible Party: Volker Burst, MD, University of Cologne
ClinicalTrials.gov Identifier: NCT01534364     History of Changes
Other Study ID Numbers: 001, 00003355
Study First Received: January 30, 2012
Last Updated: June 11, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Cologne:
acute renal failure
acute kidney injury
diet
caloric restriction
cardiac surgery
cardiothoracic surgery

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 19, 2014