Acute Renal FailureUNICORNNCT03715868
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
A study testing Non-milked derived protein source formula diet in people with Acute Renal Failure and Acute Kidney Injury, run by University of Cologne at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Acute Renal Failure, Acute Kidney Injury
- What is being tested?
- Non-milked derived protein source formula diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jan 2019to 24 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Acute Renal Failure, Acute Kidney Injury
- Being tested
- Non-milked derived protein source formula diet
- Keywords
- Acute kidney injury, Acute renal failure, Diet, Cardiothoracic surgery, Change of protein source
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-milked derived protein source formula dietOther
Formula diet based on a non-milked derived protein source
| Study group | Role | What they receive |
|---|---|---|
| Non-milked derived protein source formula diet | Active comparator | Formula diet based on a non-milked derived protein source Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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")
Measured: 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
Measured: 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
Measured: Pre-operative baseline day of surgery to day of discharge, an expected average of 10 days
Maximum serum creatinine concentration detected postoperatively during hospitalization
Measured: Pre-operative baseline day of surgery to day of discharge, an expected average of 10 days
Need for renal replacement treatment during hospitalization
Measured: Patient will be followed up for the duration of hospital stay, an expected average of 10 days
In-hospital mortality
Measured: Patient will be followed up for the duration of hospital stay, an expected average of 10 days
Length of hospital stay
Measured: Patient will be followed up for the duration of hospital stay, an expected average of 10 days
Length of stay on intensive care unit (ICU)
Measured: Day of admittance until day of discharge from ICU, an expected average of 2 days
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)
Measured: Pre-operative baseline day of surgery and at 4 hours and 24 hours after induction of ischemia
C-reactive Protein (CRP) concentration
Measured: Pre-operative day of surgery and at 24 hours after onset of ischemia
Leukocyte count
Measured: Pre-operative day of surgery and at 24 hours after onset of ischemia
Creatine kinase concentration
Measured: Pre-operative day of surgery and at 24 hours after onset of ischemia
Troponin T concentration
Measured: Pre-operative day of surgery and at 24 hours after onset of ischemia
Lactate Dehydrogenase concentration
Measured: Pre-operative day of surgery and at 24 hours after onset of ischemia
N-terminal Pro brain natriuretic peptide (NT-ProBNP) concentration
Measured: Pre-operative day of surgery and at 24 hours after onset of ischemia
Lactate concentration
Measured: Pre-operative day of surgery and at 24 hours after onset of ischemia
Amino acid pattern (concentrations), Insulin concentration, insulin-like growth factors (IGF1) concentration, glucose concentration
Measured: Before start of diet and on day of admission (before surgery)
Mortality rate at 30 and 180 days (as followed-up upon by telephone call)
Measured: Day of surgery until 180 days after time point of surgery
Need for renal replacement therapy within 180 days after time point of surgery (as followed-up upon by telephone call)
Measured: Day of surgery until 180 days after time point of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start15 Jan 2019
- Primary completion24 Aug 2020
- Study completion24 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Kabi
- Responsible party
- Principal investigator, Volker Burst, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715868
- Sponsor's protocol ID
- 004
- Acronym
- UNICORN
- Status last verified
- Apr 2021
- First submitted
- 11 Oct 2018
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36056721
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03715868
- Acronym / sponsor ID
- UNICORN / 004
- Conditions
- Acute Renal Failure, Acute Kidney Injury
- Keywords
- Acute kidney injury, Acute renal failure, Diet, Cardiothoracic surgery, Change of protein source
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- Fresenius Kabi
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 24 Aug 2020 (actual)
- Study completion
- 24 Aug 2020 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-milked derived protein source formula diet | Active comparator | Other: Non-milked derived protein source formula dietFormula diet based on a non-milked derived protein source |
| Milked derived protein source formula diet | No intervention | –Formula diet based on a milked derived protein source |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Chronic renal replacement therapy
- Status post kidney transplantation
- Vegetarian lifestyle
- BMI <18.5 kg/m2
- Calorie-reduced diet within the preceding 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-milked derived protein source formula dietFormula diet based on a non-milked derived protein source | Other | Non-milked derived protein source formula diet |
Primary outcome
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.
19 secondary outcomes
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
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
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
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
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
In-hospital mortality
Time frame: Patient will be followed up for the duration of hospital stay, an expected average of 10 days
Length of hospital stay
Time frame: Patient will be followed up for the duration of hospital stay, an expected average of 10 days
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
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
C-reactive Protein (CRP) concentration
Time frame: Pre-operative day of surgery and at 24 hours after onset of ischemia
Leukocyte count
Time frame: Pre-operative day of surgery and at 24 hours after onset of ischemia
Creatine kinase concentration
Time frame: Pre-operative day of surgery and at 24 hours after onset of ischemia
Troponin T concentration
Time frame: Pre-operative day of surgery and at 24 hours after onset of ischemia
Lactate Dehydrogenase concentration
Time frame: Pre-operative day of surgery and at 24 hours after onset of ischemia
N-terminal Pro brain natriuretic peptide (NT-ProBNP) concentration
Time frame: Pre-operative day of surgery and at 24 hours after onset of ischemia
Lactate concentration
Time frame: Pre-operative day of surgery and at 24 hours after onset of ischemia
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)
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 36056721Osterholt 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-milked derived protein source formula diet in people with Acute Renal Failure and Acute Kidney Injury, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03715868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.