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Pre-operative Short-term Administration of a Formula Diet Containing a Non-milk-derived Protein Source for Prevention of Acute Kidney Injury After Cardiac Surgery (UNICORN)

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ClinicalTrials.gov Identifier: NCT03715868
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
Fresenius Kabi
Information provided by (Responsible Party):
Volker Burst, University of Cologne

Brief Summary:

Cardiac surgery is associated with a high risk of postoperative AKI with significant morbidity and mortality. To date, no preventive or therapeutic measures exist to prevent this. According to the data from animal trials, a preoperative diet with a deficiency of milk-derived proteins may be a new preventive measure in this context.

This trial will investigate whether one week of changing the diets protein source to a non-milk-derived one prior to surgery effectively induces renal protection from post-surgery AKI in humans. Patients undergoing elective cardiac surgery are randomized into two arms. In the non-milked-derived based diet arm, patients receive an appropriate formula diet based on a protein source other than milk derived proteins. In the control arm, patients are provided with a formula diet based on milk-protein. Total amount of calories and proteins is not restricted and - due to randomization - assumed not to be significantly different between the two arms.


Condition or disease Intervention/treatment Phase
Acute Renal Failure Acute Kidney Injury Other: Non-milked derived protein source formula diet Not Applicable

Detailed Description:

Cardiac surgery is associated with a high risk of postoperative AKI with significant morbidity and mortality. Acute kidney injury (AKI) constitutes a significant complication in hospitalized patients with an incidence of about 30%. Depending on existing comorbidities, a mortality of up to 60% occurs in critically ill or postoperative patients with AKI. To date, no preventive or therapeutic measures exist to prevent this. According to the data from animal trials, a preoperative diet low in sulfur-containing amino acids may be a new preventive measure in this context.

This trial will investigate whether one week of changing the diets protein source to a non-milk-derived one prior to surgery effectively induces renal protection from post-surgery AKI in humans. Patients undergoing elective cardiac surgery are randomized into two arms.

In the non-milked-derived based diet arm, patients receive an appropriate formula diet based on a protein source other than milk derived proteins. The formula diet replaces the regular diet completely from day -7 until the scheduled cardiothoracic surgery. The amount of formula diet is based on individual calculations to cover the patients daily energy demand.

In the control arm, patients are provided with a formula diet based on milk-protein, accordingly. Total amount of calories and proteins is not restricted and - due to randomization - assumed not to be significantly different between the two arms.

The primary endpoint of the clinical trial is to investigate whether a preoperative diet with a deficiency of milk-derived proteins leads to a reduction of AKI incidence within 72 hours after surgery. AKI is defined according to 'Kidney Disease: Improving Global Outcomes' (KDIGO) classification as an increase in serum creatinine of ≥0.3 mg/dl within 48 hours, or an increase of serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days, or a reduction of urine output to <0.5ml/kg/hour for more than 6 hours.

Baseline creatinine will be assessed prior to the start of the surgical procedure. The time frame for the following assessments with respect to the primary endpoint will be 72 hours from the onset of ischemia (cross-clamping). Blood samples will be obtained at 24 hours, 48 hours, and 72 hours after cross-clamping. Hourly urine output will be assessed as long as a Foley-catheter is in place.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pre-operative Short-term Administration of a Formula Diet Containing a Non-milk-derived Protein Source for Prevention of Acute Kidney Injury After Cardiac Surgery
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Active Comparator: Non-milked derived protein source formula diet
Formula diet based on a non-milked derived protein source
Other: Non-milked derived protein source formula diet
Formula diet based on a non-milked derived protein source

No Intervention: Milked derived protein source formula diet
Formula diet based on a milked derived protein source



Primary Outcome Measures :
  1. AKI incidence within 72 hours according KDIGO classification after induction of ischemia ('cross clamping') in comparison to baseline values [ Time Frame: Pre-operative baseline day of surgery to 72 hours after induction of ischemia ]

    The primary endpoint of the clinical trial is to investigate whether a preoperative diet with a non-milked derived protein source leads to a reduction of AKI incidence within 72 hours after surgery. AKI is defined according to KDIGO as an increase in serum creatinine of ≥0.3 mg/dl within 48 hours, or an increase of serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days, or a reduction of urine output to <0.5ml/kg/hour for more than 6 hours.

    Baseline creatinine will be assessed prior to the start of the surgical procedure. The time frame for the following assessments with respect to the primary endpoint will be 72 hours from the onset of ischemia (cross-clamping). Blood samples will be obtained at 24 hours, 48 hours, and 72 hours after cross-clamping. Hourly urine output will be assessed as long as a Foley-catheter is in place.



Secondary Outcome Measures :
  1. Absolute and relative increase of serum creatinine concentration at 24 hours, 48 hours, and 72 hours after cardiac surgery ("cross clamping") [ Time Frame: Pre-operative baseline day of surgery and 24 hours, 48 hours and 72 hours after induction of ischemia ]
  2. Incidence of AKI as defined by KDIGO until discharge [ Time Frame: Pre-operative baseline day of surgery to day of discharge, an expected average of 10 days ]
  3. Occurrence of AKI according to KDIGO I, II, III [ Time Frame: Pre-operative baseline day of surgery to day of discharge, an expected average of 10 days ]
  4. Maximum serum creatinine concentration detected postoperatively during hospitalization [ Time Frame: Pre-operative baseline day of surgery to day of discharge, an expected average of 10 days ]
  5. Need for renal replacement treatment during hospitalization [ Time Frame: Patient will be followed up for the duration of hospital stay, an expected average of 10 days ]
  6. In-hospital mortality [ Time Frame: Patient will be followed up for the duration of hospital stay, an expected average of 10 days ]
  7. Length of hospital stay [ Time Frame: Patient will be followed up for the duration of hospital stay, an expected average of 10 days ]
  8. Length of stay on intensive care unit (ICU) [ Time Frame: Day of admittance until day of discharge from ICU, an expected average of 2 days ]
  9. tissue inhibitor of metalloproteinases 2 (TIMP-2) and insulin-like growth factor-binding protein 7 (IGFBP7) urine concentrations before surgery and at 4 hours and 24 hours after onset of ischemia (NephroCheck Test) [ Time Frame: Pre-operative baseline day of surgery and at 4 hours and 24 hours after induction of ischemia ]
  10. C-reactive Protein (CRP) concentration [ Time Frame: Pre-operative day of surgery and at 24 hours after onset of ischemia ]
  11. Leukocyte count [ Time Frame: Pre-operative day of surgery and at 24 hours after onset of ischemia ]
  12. Creatine kinase concentration [ Time Frame: Pre-operative day of surgery and at 24 hours after onset of ischemia ]
  13. Troponin T concentration [ Time Frame: Pre-operative day of surgery and at 24 hours after onset of ischemia ]
  14. Lactate Dehydrogenase concentration [ Time Frame: Pre-operative day of surgery and at 24 hours after onset of ischemia ]
  15. N-terminal Pro brain natriuretic peptide (NT-ProBNP) concentration [ Time Frame: Pre-operative day of surgery and at 24 hours after onset of ischemia ]
  16. Lactate concentration [ Time Frame: Pre-operative day of surgery and at 24 hours after onset of ischemia ]
  17. Amino acid pattern (concentrations), Insulin concentration, insulin-like growth factors (IGF1) concentration, glucose concentration [ Time Frame: Before start of diet and on day of admission (before surgery) ]
  18. Mortality rate at 30 and 180 days (as followed-up upon by telephone call) [ Time Frame: Day of surgery until 180 days after time point of surgery ]
  19. Need for renal replacement therapy within 180 days after time point of surgery (as followed-up upon by telephone call) [ Time Frame: Day of surgery until 180 days after time point of surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women ≥50 years of age
  2. Caucasian ethnicity
  3. Scheduled cardiac surgery with use of the heart-lung machine with a lead time of at least 9 days
  4. Written informed consent

Exclusion Criteria:

  1. Chronic renal replacement therapy
  2. Status post kidney transplantation
  3. Vegetarian lifestyle
  4. BMI <18.5 kg/m2
  5. Calorie-reduced diet within the preceding 4 weeks
  6. Underlying wasting disease
  7. Uncontrolled local or systemic infection
  8. Contraindication for enteral nutrition
  9. Known allergy to or intolerance of the ingredients of the formula diets used
  10. Pregnancy or breastfeeding
  11. Absence of safe contraceptive measures or non-occurrence of menopause (in women)
  12. Participation in other interventional trials
  13. Persons who are in a dependency/employment relationship with the investigators
  14. Accommodation in an institution by judicial or administrative order.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715868


Contacts
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Contact: Volker Burst, MD +49-221-478-86285 volker.burst@uk-koeln.de
Contact: Franziska Grundmann, MD +49-221-478-97222 franziska.grundmann@uk-koeln.de

Locations
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Germany
University Hospital of Cologne Recruiting
Cologne, Germany, 50937
Contact: Volker Burst, MD    +49(0)221 478 86285    volker.burst@uk-koeln.de   
Contact: Claas Gloistein, MD    +49(0)221 478 97222    claas.gloistein@uk-koeln.de   
Principal Investigator: Volker Burst, MD         
Sub-Investigator: Claas Gloistein, MD         
Sub-Investigator: Franziska Grundmann, MD         
Sub-Investigator: Roman Müller, MD         
Sub-Investigator: Thorsten Wahlers, MD         
Sub-Investigator: Michael Faust, MD         
Sponsors and Collaborators
University of Cologne
Fresenius Kabi

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Responsible Party: Volker Burst, Medical Doctor, University of Cologne
ClinicalTrials.gov Identifier: NCT03715868     History of Changes
Other Study ID Numbers: 004
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Volker Burst, University of Cologne:
Acute kidney injury
Acute renal failure
Diet
Cardiothoracic surgery
Change of protein source

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases