A randomised controlled trial of high-normal dose protein compared to standard-normal dose protein intake after cardiac surgery.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12612000134820
• Date of registration: 31/01/2012
• Prospective Registration: Yes
• Primary sponsor: University of Sydney
• Public title: A randomised controlled trial of high-normal dose protein compared to standard-normal dose protein intake after cardiac surgery.
• Scientific title: Nephro-protective effects of L-amino acids versus standard care/usual care in cardiac surgery adult patients at risk of developing acute kidney injury. A pilot randomised controlled trial.
• Date of first enrolment: 01/06/2012
• Target sample size: 72
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12612000134820.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 2

Countries of recruitment

Australia

Contacts

• Name: A/Prof Gordon Doig

• Name: A/Prof Gordon Doig

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cardiac Bypass Surgery Patients;Acute Kidney Injury;
Cardiac Bypass Surgery Patients
Acute Kidney Injury

Renal and Urogenital - Kidney disease

Intervention(s)

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.

Primary Outcome(s)

Number of days of clinically significant renal dysfunction, assessed and defined using the Brussels Table standards (Bernard GR, Doig GS, Hudson LD et al. Qualification of organ failure for clinical trials and clinical practice. Am J Res Crit Care Med 1995;151:A323).[Duration of Hospital Stay]

Secondary Outcome(s)

Quality of Life assessed using RAND-36.[Measured at Day 90 Post randomisation into the trial]

Days of antibiotic use. Asessed by prospectively observing and recording Antibiotics delivered to enrolled patients on each day of Hospital Stay.[Measured during Hospital Stay]

Number of days of renal replacement therapy (RRT) delivered Assessed by prospectively observing and recording renal replacement therapy (RRT) delivered to enrolled patients.[Measured during Hospital Stay]

Severity of renal dysfunction, assessed and defined using the Acute Dialysis Quality Initiative's published criteria (Bellomo R, Ronco C, Kellum JA et al. Acute renal failure-definition, outcome measures, animal models, fluid therapy and information technology needs: The second International Consensus Conference of the Acute Dialysis Quality Initiative Group. Crit Care 2004;8:R204-212).[Measured during Hospital Stay]

Duration of ICU and Hospital Stay. Assessed by prospectively observing and recording Intensive Care Unit (ICU) and Hospital Stay[Measured at Day 90 post randomisation into the trial]

Duration of Mechanical Ventilation. Assessed by prospectively observing and recording Mechanical Ventilation delivered to enrolled patients.[Measured during ICU Stay]

Need for dialysis - i.e. is the patient receiving or scheduled to receive any form of dialysis (continuous haemodyalsis, intermittent peritoneal dialysis etc) at Day 90[Measured at Day 90 post randomisation into the trial]

Secondary ID(s)

None

Source(s) of Monetary Support

North Shore Heart Research Foundation

Ethics review

Status: Not approved
Approval date:
Contact:

Harbour HREC