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

NCT03715868 | Completed

• 1 other identifier: 004
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Renal Failure; Acute Kidney Injury

Keywords

Acute kidney injury; Acute renal failure; Diet; Cardiothoracic surgery; Change of protein source

Outcome Measures

Primary Outcomes (1)

• AKI incidence within 72 hours according KDIGO classification after induction of ischemia ('cross clamping') in comparison to baseline values

  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.

  Pre-operative baseline day of surgery to 72 hours after induction of ischemia

Secondary Outcomes (19)

• Absolute and relative increase of serum creatinine concentration at 24 hours, 48 hours, and 72 hours after cardiac surgery ("cross clamping")

  Pre-operative baseline day of surgery and 24 hours, 48 hours and 72 hours after induction of ischemia

• Incidence of AKI as defined by KDIGO until discharge

  Pre-operative baseline day of surgery to day of discharge, an expected average of 10 days

• Occurrence of AKI according to KDIGO I, II, III

  Pre-operative baseline day of surgery to day of discharge, an expected average of 10 days

• Maximum serum creatinine concentration detected postoperatively during hospitalization

  Pre-operative baseline day of surgery to day of discharge, an expected average of 10 days

• Need for renal replacement treatment during hospitalization

  Patient will be followed up for the duration of hospital stay, an expected average of 10 days

Study Arms (2)

Non-milked derived protein source formula diet

ACTIVE COMPARATOR

Formula diet based on a non-milked derived protein source

Other: Non-milked derived protein source formula diet

Milked derived protein source formula diet

NO INTERVENTION

Formula diet based on a milked derived protein source

Interventions

Non-milked derived protein source formula diet OTHER

Formula diet based on a non-milked derived protein source

Non-milked derived protein source formula diet

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cologne: lead
• Fresenius Kabi: collaborator

Study Sites (1)

University Hospital of Cologne

Cologne, 50937, Germany

Location

Related Publications (1)

• Osterholt T, Gloistein C, Todorova P, Becker I, Arenskrieger K, Melka R, Koehler FC, Faust M, Wahlers T, Benzing T, Muller RU, Grundmann F, Burst V. Preoperative Short-Term Restriction of Sulfur-Containing Amino Acid Intake for Prevention of Acute Kidney Injury After Cardiac Surgery: A Randomized, Controlled, Double-Blind, Translational Trial. J Am Heart Assoc. 2022 Sep 6;11(17):e025229. doi: 10.1161/JAHA.121.025229. Epub 2022 Sep 3.

  PMID: 36056721 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 23, 2018
• Study Start: January 15, 2019
• Primary Completion: August 24, 2020
• Study Completion: August 24, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

DE (1)