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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2020-08-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Oral Protein Load on Kidney Function in Patients Undergoing Cardiac Surgery

NCT03102541

Acute Kidney Injury

COMPLETED

A Study to Understand How Cardiac Surgery-associated Acute Kidney Injury Develops in Participants Who Undergo Heart Surgery With the Use of Heart-lung Machine

NCT06772025

Cardiac Surgery-associated Acute Kidney Injury

RECRUITING NA

Neutral Endopeptidase for Early Detection of Acute Kidney Injury After Cardiac Surgery

NCT03854825

Acute Kidney Injury

COMPLETED

Acute Kidney Injury Following Cardiac Surgery

NCT03102528

Acute Kidney Injury

COMPLETED

Acute Kidney Injury After Cardiac Surgery: Novel Ultrasound Techniques for Prediction of Acute Kidney Injury

NCT03727204

Acute Kidney Injury Acute Renal Failure Cardiac Surgery

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Renal Failure Acute Kidney Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non-milked derived protein source formula diet

Formula diet based on a non-milked derived protein source

Group Type ACTIVE_COMPARATOR

Non-milked derived protein source formula diet

Intervention Type OTHER

Formula diet based on a non-milked derived protein source

Milked derived protein source formula diet

Formula diet based on a milked derived protein source

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Non-milked derived protein source formula diet

Formula diet based on a non-milked derived protein source

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No