Acute Renal FailureCR_KCHNCT01534364
Brief Title:Effect of a Preoperative Calorie Restriction on Renal Function After Cardiac Surgery
A study testing calorie restriction in people with Acute Renal Failure, run by University of Cologne at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure
- What is being tested?
- calorie restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Feb 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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
- Participation in other interventional clinical trials.
- Missing safe method of contraception or missing occurence of menopause (in female)
- Professional or private relationship between subject and the investigators or dependence on the investigators.
- Placement in an institution based on official orders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Preoperative Calorie Restriction on Renal Function After Cardiac Surgery
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.
Read the detailed description
Patients with cardiothoracic surgery are at risk for postoperative acute renal failure which is associated with significant morbidity and mortality. There is no drug or procedure known to prevent this loss of renal function. Experimental data suggests, that a preoperative caloric restriction might provide kidney protection in this context. This clinical trial investigates if this phenomenon is also applicable in humans. Patients with a increased risk for a postoperative renal failure due to known chronic kidney disease are randomized in 2 groups. Patients of the diet group receive a 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). Patients of the control group receive alimentation ad libitum.
Primary objective is 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) in order to analyse if a preoperative calorie restriction as a preventive strategy leads to a attenuation of postoperative kidney injury. Hypothesis: A seven day calorie restriction reduces the increase of serum creatinine after cardiac surgery in patients with known chronic kidney disease.
- Conditions
- Acute Renal Failure
- Being tested
- calorie restriction
- Keywords
- acute renal failure, acute kidney injury, diet, caloric restriction, cardiac surgery, cardiothoracic surgery
- 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.
calorie restrictionOther
Also called calorie restriction with Fresubin energy fibre drink
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: calorie restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: baseline and 8 hours after induction of ischemia
C-reactive Protein (CRP) 24h after induction of ischemia
Measured: baseline and 24 h after induction of ischemia
Leucocyte count 24h after induction of ischemia
Measured: baseline and 24h after induction of ischemia
Creatinkinase (CK) 24h after induction of ischemia
Measured: baseline and 24 h after induction of ischemia
Troponin T 24h after induction of ischemia
Measured: baseline and 24 h after induction of ischemia
Lactate dehydrogenase 24h after induction of ischemia
Measured: baseline and 24 h after ischemia
N-terminal pro brain natriuretic peptide (NT-ProBNP) 24h after induction of ischemia
Measured: baseline and 24 h after ischemia
Serum lactate 24h after induction of ischemia
Measured: baseline and 24 hours after ischemia
Maximum increase of serum creatinine within the first 48 h after induction of ischemia
Measured: baseline and 48 hours after ischemia
Necessity of renal replacement therapy during hospital stay
Measured: pt will be followed for the duration of hospital stay, an expected average of 10 days
In-hospital mortality
Measured: pt will be followed for the duration of hospital stay, an expected average of 10 days
Time until fit for discharge
Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Length of hospital stay
Measured: Pt will be followed for the duration of hospital stay an expected average of 10 days
Echocardiographic estimated left-ventricular ejection fraction as per file, if assessed postoperatively
Measured: baseline and postoperatively, expected within 10 days after operation
Occurrence of acute renal failure in accordance with KDIGO I, II, III
Measured: Patients will be followed during hospital stay, an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2015
- Study completionFeb 2015
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
- None (open label)
- Enrolment
- 82 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
- Investigators
- Volker Burst, MD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534364
- Sponsor's protocol ID
- 001
- Other IDs
- 00003355
- Acronym
- CR_KCH
- Status last verified
- Aug 2019
- First submitted
- 30 Jan 2012
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29535139
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Preoperative Calorie Restriction on Renal Function After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01534364
- Acronym / sponsor ID
- CR_KCH / 001
- Conditions
- Acute Renal Failure
- Keywords
- acute renal failure, acute kidney injury, diet, caloric restriction, cardiac surgery, cardiothoracic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- Fresenius Kabi
- Study start
- Jan 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 16 Feb 2012 (estimated)
- 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.
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.
Detailed description
Patients with cardiothoracic surgery are at risk for postoperative acute renal failure which is associated with significant morbidity and mortality. There is no drug or procedure known to prevent this loss of renal function. Experimental data suggests, that a preoperative caloric restriction might provide kidney protection in this context. This clinical trial investigates if this phenomenon is also applicable in humans. Patients with a increased risk for a postoperative renal failure due to known chronic kidney disease are randomized in 2 groups. Patients of the diet group receive a 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). Patients of the control group receive alimentation ad libitum.
Primary objective is 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) in order to analyse if a preoperative calorie restriction as a preventive strategy leads to a attenuation of postoperative kidney injury. Hypothesis: A seven day calorie restriction reduces the increase of serum creatinine after cardiac surgery in patients with known chronic kidney disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Ad libitum alimentation |
| calorie restriction | Other | Other: calorie restrictionCalorie 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (19 listed)
- 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
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 |
|---|---|---|
| calorie restrictionAlso: calorie restriction with Fresubin energy fibre drinkCalorie 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 |
Primary outcome
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).
Time frame: baseline and 24 hours after induction of ischemia
15 secondary outcomes
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).
Time frame: baseline and 8 hours after induction of ischemia
C-reactive Protein (CRP) 24h after induction of ischemia
Time frame: baseline and 24 h after induction of ischemia
Leucocyte count 24h after induction of ischemia
Time frame: baseline and 24h after induction of ischemia
Creatinkinase (CK) 24h after induction of ischemia
Time frame: baseline and 24 h after induction of ischemia
Troponin T 24h after induction of ischemia
Time frame: baseline and 24 h after induction of ischemia
Lactate dehydrogenase 24h after induction of ischemia
Time frame: baseline and 24 h after ischemia
N-terminal pro brain natriuretic peptide (NT-ProBNP) 24h after induction of ischemia
Time frame: baseline and 24 h after ischemia
Serum lactate 24h after induction of ischemia
Time frame: baseline and 24 hours after ischemia
Maximum increase of serum creatinine within the first 48 h after induction of ischemia
Time frame: baseline and 48 hours after ischemia
Necessity of renal replacement therapy during hospital stay
Time frame: pt will be followed for the duration of hospital stay, an expected average of 10 days
In-hospital mortality
Time frame: pt will be followed for the duration of hospital stay, an expected average of 10 days
Time until fit for discharge
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Length of hospital stay
Time frame: Pt will be followed for the duration of hospital stay an expected average of 10 days
Echocardiographic estimated left-ventricular ejection fraction as per file, if assessed postoperatively
Time frame: baseline and postoperatively, expected within 10 days after operation
Occurrence of acute renal failure in accordance with KDIGO I, II, III
Time frame: Patients will be followed during hospital stay, an expected average of 10 days
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 9 Aug 2019.
- Derived from this study: PubMed 29535139Grundmann 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.
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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.
Volker Burst, MD principal investigator
University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calorie restriction in people with Acute Renal Failure, 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 12 inclusion and 19 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 9 Aug 2019. 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?
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). (time frame: baseline and 24 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 NCT01534364, 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 9 Aug 2019.