Nephro-protective effects of L-amino acids in critically ill patients. A phase II multicentre randomised controlled trial.

Nephro-protective effects of L-amino acids versus standard care/usual care in critically ill adult patients at risk of developing acute kidney injury. A phase II multi-centre randomised controlled trial.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609001015235

Enrollment

474

Registered

2009-11-23

Start date

2010-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Supplementary infusion of L-amino acids to achieve 2g/kg/day total protein intake on each day for the entire duration of Intensive Care Unit (ICU) stay

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

Inclusion criteria

Patients will be screened for eligibility within 24hrs of admission to study Intensive Care Unit (ICU). Patients will be considered eligible for the trial if all of the following inclusion criteria are met at the time of screening: 1)Presence of a central venous access line through which the study intervention could be delivered; 2)Expected to remain in the ICU for at least 3 days; 3)At least 18yrs of age; 4)Admitted to the study ICU for less than 24hours

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)Receiving an non steroidal anti-inflammatory drugs (NSAID) with specific emphasis on COX-2 inhibitors; 2)Receiving a nitrous oxide (NO) inhibitor; 3)Receiving a diuretic that acts on the proximal tubule (Ex. acetazolaminde); 4)Pre-existing chronic kidney disease; 5)Pre-existing ongoing need for chronic dialysis; 6)Recent kidney transplant; 7)Intensive Care Unit (ICU) length of stay at the time of screening is greater than 24hrs; 8)Admitted to the Intensive Care Unit (ICU) for palliative care and is not expected to survive to hospital discharge; 9)Moribund and not expected to survive 24hrs; 10)Brain dead or suspected to be brain dead; 11)Admitted to the study Intensive Care Unit (ICU) directly from another ICU; 12)Documented contraindications to the study intervention (Intravenous (IV) L-amino acids), as listed on the Therapeutic Goods Administration (TGA) product licensing document; or 13)Clinically significant acute kidney injury at the time of screening.

Outcome results