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

Acute Renal Failure Clinical Trial

— CR_KCH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534364
• Other study ID #: 001
• Secondary ID: 00003355
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: February 2015

Study information

• Verified date: August 2019
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Renal Insufficiency

Intervention

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)

Locations

Country	Name	City	State
Germany	University of Cologne	Cologne

Sponsors (2)

Lead Sponsor	Collaborator
University of Cologne	Fresenius Kabi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		baseline and 24 hours after induction of ischemia
Secondary	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).		baseline and 8 hours after induction of ischemia
Secondary	C-reactive Protein (CRP) 24h after induction of ischemia		baseline and 24 h after induction of ischemia
Secondary	Leucocyte count 24h after induction of ischemia		baseline and 24h after induction of ischemia
Secondary	Creatinkinase (CK) 24h after induction of ischemia		baseline and 24 h after induction of ischemia
Secondary	Troponin T 24h after induction of ischemia		baseline and 24 h after induction of ischemia
Secondary	Lactate dehydrogenase 24h after induction of ischemia		baseline and 24 h after ischemia
Secondary	N-terminal pro brain natriuretic peptide (NT-ProBNP) 24h after induction of ischemia		baseline and 24 h after ischemia
Secondary	Serum lactate 24h after induction of ischemia		baseline and 24 hours after ischemia
Secondary	Maximum increase of serum creatinine within the first 48 h after induction of ischemia		baseline and 48 hours after ischemia
Secondary	Necessity of renal replacement therapy during hospital stay		pt will be followed for the duration of hospital stay, an expected average of 10 days
Secondary	In-hospital mortality		pt will be followed for the duration of hospital stay, an expected average of 10 days
Secondary	Time until fit for discharge		Participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary	Length of hospital stay		Pt will be followed for the duration of hospital stay an expected average of 10 days
Secondary	Echocardiographic estimated left-ventricular ejection fraction as per file, if assessed postoperatively		baseline and postoperatively, expected within 10 days after operation
Secondary	Occurrence of acute renal failure in accordance with KDIGO I, II, III		Patients will be followed during hospital stay, an expected average of 10 days