None listed
Conditions
Brief summary
The purpose of this research study is to investigate whether a treatment involving the delivery of protein supplements into the vein (intravenous) can protect cardiac bypass surgery patients from the onset of a new kidney injury, when compared with standard treatment.
Interventions
Supplementary infusion of L-amino acids to achieve 2g/kg/day total protein intake on each day that they have a central venous catheter insitu.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with pre-existing Chronic Kidney Disease Stage 3 or higher (eGFR <60 ml/min/1.73m2) who are scheduled to undergo on-pump valve replacement or on-pump coronary artery bypass graft surgery expected to require longer than one hour on-pump will be considered eligible. Unless at least one of the Exclusion Criteria listed below is met, these patients will be approached to provide informed consent to participate.
Exclusion criteria
Patients will be considered ineligible for the trial if any of the following exclusion criteria are met at the time of screening: 1)Was the actual on-pump surgical time less than 1 hour; 2) The patient does not have a central venous access line through which the study intervention could be delivered; 3) The patient is not able to tolerate at least 1L of fluid volume per day; 4) The patient is currently less than 18 years old; 5) Is the patient receiving NSAID, with specific emphasis on COX-2 inhibitors during their ICU or hospital stay; 6) Is the patient currently enrolled into a clinical trial evaluating a nitric oxide (NO) inhibitor; 7) Is the patient receiving Acetazolamide, which is a diuretic that works on the proximal tubule; 8) Is the patient's current eGFR < 20 ml/min/1.73 m2; 9) Is the patient currently known to have severe Acute Kidney Injury, defined as a Current serum creatinine (SCr) increased 3 times pre-acute illness value OR SCr >350umol/L with recent increase greater than 44 umol/L; 10) Is the patient receiving or scheduled to begin dialysis/renal replacement therapy; 11) Has the patient ever had a kidney transplant; 12) Is the patient expected to receive palliative care only and is not expected to survive ICU or hospital discharge; 13) Is the patient moribund and not expected to survive 24 hrs; 14) Is the patient brain dead or suspected to be brain dead; 15) Has the patient been taking Nardil (phenelzine) within the last 6 weeks; 16) Has the patient previously been enrolled and randomised into this study; 17) Does the patient have a documented contraindication to the study intervention (IV amino acids) as listed on the TGA product licensing document.
Outcome results
None listed