None listed
Conditions
Brief summary
Acute kidney injury is common in critically ill patients, especially in those requiring vasopressor therapy. We hypothesize that an intravenous infusion of amino acids in such patients will increase glomerular function without tubular injury when compared to a balanced crystalloid solution of equal volume. In this two-centre, pilot safety and efficacy randomised controlled trial we plan to enrol 60 adult patients with the study drug delivered via infusion while the participant is in the intensive care unit.
Interventions
Synthamin-17 without electrolytes will be administered as a single continuous Intravenous infusion for 36 hours at a rate of 42 mls/hour to deliver a dose of 2 g/kg/day of ideal body weight (to a maximum of 100 g/day) that will be commenced and only given while the participant is in the intensive care unit. Adherence will be monitored via electronic medical record review. The composition of Synthamin-17 10% without electrolytes is:
- The excipients are sodium metabisulfite, acetic acid and wate
Synthamin-17 without electrolytes will be administered as a single continuous Intravenous infusion for 36 hours at a rate of 42 mls/hour to deliver a dose of 2 g/kg/day of ideal body weight (to a maximum of 100 g/day) that will be commenced and only given while the participant is in the intensive care unit. Adherence will be monitored via electronic medical record review. The composition of Synthamin-17 10% without electrolytes is: - The excipients are sodium metabisulfite, acetic acid and water for injection. - Essential amino acids: Leucine 7.30 g, Phenylalanine 5.60 g, Methionine 4.00 g, Lysine (as the hydrochloride salt) 5.80 g, Isoleucine 6.00 g, Valine 5.80 g, Histidine 4.80 g, Threonine 4.20 g, Tryptophan 1.80 g. - Non-essential amino acids: Alanine 20.7 g, Glycine 10.3 g, Arginine 11.5 g, Proline 6.80 g, Tyrosine 400 mg, Serine 5.00 g.
Sponsors
Austin Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult aged equal to or greater than 18 years Admitted to the intensive care unit for less than 72 hours Receiving vasopressor therapy and expected to continue for 24 hours The patient is expected to remain in ICU for greater than 24 hours Appropriate intravascular device, such as a central line or peripherally inserted central catheter, to administer the intervention Appropriate devices to collect samples; arterial line and indwelling urinary catheter
Exclusion criteria
Severe Acute kidney injury, as defined by Kidney Disease Improving Global Outcomes (KDIGO) stage 3 criteria Requirement for renal replacement thearapy, such as dialysable toxin Urea greater than 30 mmol/L Absence of a central access device Already of vasopressor therapy for greater than 24 hours Pre-admission chronic kidney disease with an estimated glomerular filtration rate of less than of less than 30 ml/min Acute estimated glomerular filtration rate of less than 30 ml/min Chronic haemodialysis or peritoneal dialysis Need for extracorporeal membrane oxygenation Previous enrolment in this study Pregnant or lactating Patients who are not to receive full active treatment Transferred from another intensive care unit
Outcome results
None listed