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Completed

NCT Number: NCT01534364

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cologne

Cologne, 50937, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Other names: calorie restriction with Fresubin energy fibre drink

Primary outcomes

  1. 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 outcomes

  1. 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

  2. C-reactive Protein (CRP) 24h after induction of ischemia

    Time frame: baseline and 24 h after induction of ischemia

  3. Leucocyte count 24h after induction of ischemia

    Time frame: baseline and 24h after induction of ischemia

  4. Creatinkinase (CK) 24h after induction of ischemia

    Time frame: baseline and 24 h after induction of ischemia

  5. Troponin T 24h after induction of ischemia

    Time frame: baseline and 24 h after induction of ischemia

  6. Lactate dehydrogenase 24h after induction of ischemia

    Time frame: baseline and 24 h after ischemia

  7. N-terminal pro brain natriuretic peptide (NT-ProBNP) 24h after induction of ischemia

    Time frame: baseline and 24 h after ischemia

  8. Serum lactate 24h after induction of ischemia

    Time frame: baseline and 24 hours after ischemia

  9. Maximum increase of serum creatinine within the first 48 h after induction of ischemia

    Time frame: baseline and 48 hours after ischemia

  10. 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

  11. In-hospital mortality

    Time frame: pt will be followed for the duration of hospital stay, an expected average of 10 days

  12. Time until fit for discharge

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days

  13. Length of hospital stay

    Time frame: Pt will be followed for the duration of hospital stay an expected average of 10 days

  14. Echocardiographic estimated left-ventricular ejection fraction as per file, if assessed postoperatively

    Time frame: baseline and postoperatively, expected within 10 days after operation

  15. 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

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Collaborators

  • Fresenius Kabi

Registry information

Official study title

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

Acronym: CR_KCH

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 16, 2012
Registry last updated
Aug 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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