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Intravenous Amino Acid Therapy for Kidney Protection in Cardiac Surgery. (PROTection)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03709264
Recruitment Status : Active, not recruiting
First Posted : October 17, 2018
Last Update Posted : April 5, 2024
Sponsor:
Information provided by (Responsible Party):
Giovanni Landoni, Università Vita-Salute San Raffaele

Study Description
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Brief Summary:

To date, no pharmacological agents are proven efficacious in treating perioperative AKI. There is a strong biological rationale for the administration of amino acid in the management of patients at risk of AKI with increases in renal blood flow and GFR of 25 to 60% for several hours after the administration of amino acids (Woods LL 1993) mediated by a afferent arteriolar dilation.(Meyer TW 1983) Moreover, animal models have demonstrated that an increase in renal blood flow in response to a short-term amino acid infusion can protect the kidney from acute ischemic insults. Finally, these nephro-protective effects are preserved in critical illness. Cardiac surgery appears to be the best setting to test the likely beneficial renal effects of amino acid because of pathophysiological principles and the ability to intervene before the injury has begun. Although the etiology of AKI in cardiac surgery is multifactorial, renal hypoperfusion is believed to play a major role in this development by decreasing renal perfusion through a reduction in renal blood flow and through the activation of the sympathetic nervous system and the renin-angiotensin system with afferent arteriolar vasoconstriction. In this setting, a global increase in renal blood flow by means of Amino Acid therapy appears a logical and promising intervention.

The primary aim of the study is to determine whether providing continuous infusion of a balanced mixture of amino acids, compared to placebo (balanced crystalloid solution), reduces the incidence of acute kidney injury (AKI) in patients scheduled for cardiac surgery defined as KDIGO stage 1 or greater during hospital stay.


Condition or disease Intervention/treatment Phase
Cardiac Surgery Drug: Amino Acids Drug: Placebos Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3511 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Amino Acid Therapy for Kidney Protection in Cardiac Surgery: a Multi-centre Randomized Blinded Placebo Controlled Clinical Trial.
Actual Study Start Date : October 7, 2019
Actual Primary Completion Date : January 17, 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arms and Interventions
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Arm Intervention/treatment
Experimental: Amino Acids infusion Drug: Amino Acids
Patients randomized to experimental arm receive a continuous infusion of a balanced mixture of amino acids in a dose of 2 g/kg ideal body weight/day (to a maximum 100 g/day) from the operating room admission up to either death, start of RRT, ICU discharge or 72 hours after treatment initiation, trough a central venous line
Placebo Comparator: Placebo Drug: Placebos
Placebo: standard treatment


Outcome Measures
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Primary Outcome Measures :
  1. AKI incidence [ Time Frame: Until hospital discharge, an average of 10 days ]
    Incidence of Acute Kidney Injury during hospital stay


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 180 days ]
    All-cause mortality at ICU discharge, hospital discharge, 30 and 90 and 180 days after randomization

  2. RRT [ Time Frame: 180 days ]
    Need and duration of renal replacement therapy

  3. ICU stay [ Time Frame: Until ICU discharge, an average of 2 days ]
    Duration of Intensive Care Unit stay

  4. Hospital stay [ Time Frame: Until hospital discharge, an average of 10 days ]
    Duration of hospital stay

  5. Mechanical Ventilation [ Time Frame: Until ICU discharge, an average of 2 days ]
    Need and duration of mechanical ventilation

  6. EQ-5D [ Time Frame: 180 days ]
    Quality of life at 180 days after randomization as measured by the EQ-5D


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18 years
  • scheduled cardiac surgery
  • expected to stay in ICU at least 1 night after surgery
  • signed informed consent

Exclusion Criteria:

  • Patient currently enrolled into another randomized clinical trial
  • Patient currently receiving or scheduled for intermittent or continuous renal replacement therapy
  • Patients with CKD of equal or more than CKD stage IV (GFR<30 ml/min/1.73 m2)
  • Patient with a kidney transplant
  • Patient is not expected to survive ICU or hospital discharge
  • Patient previously been enrolled and randomized into this study
  • Patient has severe liver disease (Child-Pugh score >7 points)
  • Patient has a hypersensitivity (known allergy) to one or more of the included amino acids
  • Patient has a congenital alteration of amino acid metabolism
  • Pregnant or currently breastfeeding patients
  • Patients with any of the contraindications reported in the summary product characteristics.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709264


Locations
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Sponsors and Collaborators
Università Vita-Salute San Raffaele
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Landoni G, Brambillasca C, Baiardo Redaelli M, Bradic N, Ti LK, Povsic-Cevra Z, Nepomniashchikh VA, Zoccai GB, D'Ascenzo F, Romagnoli E, Scandroglio AM, Ballotta A, Rondello N, Franco A, Massaro C, Viscido C, Calabro MG, Garofalo E, Canichella F, Monaco F, Severi L, Pisano A, Barucco G, Venditto M, Federici F, Licheri M, Paternoster G, Trompeo A, Belletti A, Mantovani LF, Perone R, Dalessandro G, Kroeller D, Haxhiademi D, Galbiati C, Tripodi VF, Giardina G, Lembo R, Nakhnoukh C, Guarracino F, Longhini F, Bove T, Zangrillo A, Bellomo R, Fominskiy E. Intravenous amino acid therapy for kidney protection in cardiac surgery a protocol for a multi-centre randomized blinded placebo controlled clinical trial. The PROTECTION trial. Contemp Clin Trials. 2022 Oct;121:106898. doi: 10.1016/j.cct.2022.106898. Epub 2022 Aug 28.

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Responsible Party: Giovanni Landoni, MD, Associate Professor, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT03709264    
Other Study ID Numbers: PROTection/47/OSR
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: April 5, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Giovanni Landoni, Università Vita-Salute San Raffaele:
kidney protection
acute kidney injury
cardiac surgery
 amino acids
mortality
ICU