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| ID | Type | Description | Link |
|---|---|---|---|
| 00003355 | Registry Identifier | DRKS |
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| Name | Class |
|---|---|
| Fresenius Kabi | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | Ad libitum alimentation | |
| calorie restriction | Other | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calorie restriction | Other | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| C-reactive Protein (CRP) 24h after induction of ischemia |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Volker Burst, MD | University of Cologne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cologne | Cologne | 50937 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29535139 | Derived | 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. |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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|
| baseline and 24 h after induction of ischemia |
| Leucocyte count 24h after induction of ischemia | baseline and 24h after induction of ischemia |
| Creatinkinase (CK) 24h after induction of ischemia | baseline and 24 h after induction of ischemia |
| Troponin T 24h after induction of ischemia | baseline and 24 h after induction of ischemia |
| Lactate dehydrogenase 24h after induction of ischemia | baseline and 24 h after ischemia |
| N-terminal pro brain natriuretic peptide (NT-ProBNP) 24h after induction of ischemia | baseline and 24 h after ischemia |
| Serum lactate 24h after induction of ischemia | baseline and 24 hours after ischemia |
| Maximum increase of serum creatinine within the first 48 h after induction of ischemia | baseline and 48 hours after ischemia |
| Necessity of renal replacement therapy during hospital stay | pt will be followed for the duration of hospital stay, an expected average of 10 days |
| In-hospital mortality | pt will be followed for the duration of hospital stay, an expected average of 10 days |
| Time until fit for discharge | Participants will be followed for the duration of hospital stay, an expected average of 10 days |
| Length of hospital stay | 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 | baseline and postoperatively, expected within 10 days after operation |
| 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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |