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

NCT01534364 | Completed DMC

• 2 other identifiers: 00100003355
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Renal Failure

Keywords

acute renal failure; acute kidney injury; diet; caloric restriction; cardiac surgery; cardiothoracic surgery

Outcome Measures

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).

  baseline and 24 hours after induction of ischemia

Secondary Outcomes (15)

• 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

  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

Study Arms (2)

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)

Other: calorie restriction

Interventions

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)

Also known as: calorie restriction with Fresubin energy fibre drink

calorie restriction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead
• Fresenius Kabi: collaborator

Study Sites (1)

University of Cologne

Cologne, 50937, Germany

Location

Related Publications (1)

• 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.

  PMID: 29535139 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Volker Burst, MD

  University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 30, 2012
• First Posted: February 16, 2012
• Study Start: January 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: August 9, 2019

Record last verified: 2019-08

Locations

DE (1)