Back to resultsBrief Title:Effect of a Preoperative Calorie Restriction on Renal Function After Cardiac Surgery (CR_KCH)
Primary Purpose
Acute Renal Failure
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
calorie restriction
Sponsored by
About this trial
This is an interventional prevention trial for Acute Renal Failure focused on measuring acute renal failure, acute kidney injury, diet, caloric restriction, cardiac surgery, cardiothoracic surgery
Eligibility Criteria
Inclusion Criteria:
- Men and women 18 years of age or older
- Caucasian origin
- Scheduled cardiothoracic operation with employment of cardio-pulmonary bypass and a lead time of 11 days minimum.
- Indication for cardiac surgery is determined by the cardiothoracic specialist
- Patient and/or legal guardian must be willing and able to give written informed consent
one of the following risk factors:
- serum creatinine >1,1 mg/dl in male and > 0,9 mg/dl in female
- type 2 diabetes
- peripheral artery occlusive disease
- heart failure with NYHA III-IV (ejection fraction < 50 %)
- combined CABG and heart valve surgery
- further surgery after CABG or heart valve surgery
Exclusion Criteria:
- End-stage renal disease (patient on dialysis)
- Indwelling kidney transplant
- Malnutrition (BMI < 18,5 kg/m2)
- Body weight < 46 kg in male and < 51 kg in female
- BMI > 35 kg/m2 or body weight > 120 kg
- Catabolic state (serum albumine < 25 g/l)
- Diet within the previous 4 weeks
- Inappetence
- Weight loss > 1 kg within the previous 2 weeks, if not explained by use of diuretics
- Hospital stay during the last 7 days prior to cardiac surgery
- Consuming underlying disease
- Uncontrolled local or systemic infection
- Contraindication for enteral nutrition.
- Known allergy against or incompatibility with ingredients of the employed formula-diet
- Pregnancy or breast feeding
- Participation in other interventional clinical trials.
- Missing safe method of contraception or missing occurence of menopause (in female)
- Professional or private relationship between subject and the investigators or dependence on the investigators.
- Placement in an institution based on official orders.
Sites / Locations
- University of Cologne
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
control
calorie restriction
Arm Description
Ad libitum alimentation
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)
Outcomes
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).
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).
C-reactive Protein (CRP) 24h after induction of ischemia
Leucocyte count 24h after induction of ischemia
Creatinkinase (CK) 24h after induction of ischemia
Troponin T 24h after induction of ischemia
Lactate dehydrogenase 24h after induction of ischemia
N-terminal pro brain natriuretic peptide (NT-ProBNP) 24h after induction of ischemia
Serum lactate 24h after induction of ischemia
Maximum increase of serum creatinine within the first 48 h after induction of ischemia
Necessity of renal replacement therapy during hospital stay
In-hospital mortality
Time until fit for discharge
Length of hospital stay
Echocardiographic estimated left-ventricular ejection fraction as per file, if assessed postoperatively
Occurrence of acute renal failure in accordance with KDIGO I, II, III
Full Information
NCT ID
NCT01534364
First Posted
January 30, 2012
Last Updated
August 8, 2019
Sponsor
University of Cologne
Collaborators
Fresenius Kabi
1. Study Identification
Unique Protocol Identification Number
NCT01534364
Brief Title
Brief Title:Effect of a Preoperative Calorie Restriction on Renal Function After Cardiac Surgery
Acronym
CR_KCH
Official Title
Effect of a Preoperative Calorie Restriction on Renal Function After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
Collaborators
Fresenius Kabi
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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Renal Failure
Keywords
acute renal failure, acute kidney injury, diet, caloric restriction, cardiac surgery, cardiothoracic surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
Ad libitum alimentation
Arm Title
calorie restriction
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
calorie restriction
Other Intervention Name(s)
calorie restriction with Fresubin energy fibre drink
Intervention Description
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)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
C-reactive Protein (CRP) 24h after induction of ischemia
Time Frame
baseline and 24 h after induction of ischemia
Title
Leucocyte count 24h after induction of ischemia
Time Frame
baseline and 24h after induction of ischemia
Title
Creatinkinase (CK) 24h after induction of ischemia
Time Frame
baseline and 24 h after induction of ischemia
Title
Troponin T 24h after induction of ischemia
Time Frame
baseline and 24 h after induction of ischemia
Title
Lactate dehydrogenase 24h after induction of ischemia
Time Frame
baseline and 24 h after ischemia
Title
N-terminal pro brain natriuretic peptide (NT-ProBNP) 24h after induction of ischemia
Time Frame
baseline and 24 h after ischemia
Title
Serum lactate 24h after induction of ischemia
Time Frame
baseline and 24 hours after ischemia
Title
Maximum increase of serum creatinine within the first 48 h after induction of ischemia
Time Frame
baseline and 48 hours after ischemia
Title
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
Title
In-hospital mortality
Time Frame
pt will be followed for the duration of hospital stay, an expected average of 10 days
Title
Time until fit for discharge
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 10 days
Title
Length of hospital stay
Time Frame
Pt will be followed for the duration of hospital stay an expected average of 10 days
Title
Echocardiographic estimated left-ventricular ejection fraction as per file, if assessed postoperatively
Time Frame
baseline and postoperatively, expected within 10 days after operation
Title
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
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 cardiothoracic operation with employment of cardio-pulmonary bypass and a lead time of 11 days minimum.
Indication for cardiac surgery is determined by the cardiothoracic specialist
Patient and/or legal guardian must be willing and able to give written informed consent
one of the following risk factors:
serum creatinine >1,1 mg/dl in male and > 0,9 mg/dl in female
type 2 diabetes
peripheral artery occlusive disease
heart failure with NYHA III-IV (ejection fraction < 50 %)
combined CABG and heart valve surgery
further surgery after CABG or heart valve surgery
Exclusion Criteria:
End-stage renal disease (patient on dialysis)
Indwelling kidney transplant
Malnutrition (BMI < 18,5 kg/m2)
Body weight < 46 kg in male and < 51 kg in female
BMI > 35 kg/m2 or body weight > 120 kg
Catabolic state (serum albumine < 25 g/l)
Diet within the previous 4 weeks
Inappetence
Weight loss > 1 kg within the previous 2 weeks, if not explained by use of diuretics
Hospital stay during the last 7 days prior to cardiac surgery
Consuming underlying disease
Uncontrolled local or systemic infection
Contraindication for enteral nutrition.
Known allergy against or incompatibility with ingredients of the employed formula-diet
Pregnancy or breast feeding
Participation in other interventional clinical trials.
Missing safe method of contraception or missing occurence of menopause (in female)
Professional or private relationship between subject and the investigators or dependence on the investigators.
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 of Cologne
City
Cologne
ZIP/Postal Code
50937
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
29535139
Citation
Grundmann F, Muller RU, Reppenhorst A, Hulswitt L, Spath MR, Kubacki T, Scherner M, Faust M, Becker I, Wahlers T, Schermer B, Benzing T, Burst V. Preoperative Short-Term Calorie Restriction for Prevention of Acute Kidney Injury After Cardiac Surgery: A Randomized, Controlled, Open-Label, Pilot Trial. J Am Heart Assoc. 2018 Mar 13;7(6):e008181. doi: 10.1161/JAHA.117.008181.
Results Reference
derived
Learn more about this trial
Brief Title:Effect of a Preoperative Calorie Restriction on Renal Function After Cardiac Surgery
We'll reach out to this number within 24 hrs