Clinical Trials Logo
  1. Home
  2. Cardiac Surgery
  3. NCT03709264

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

Cardiac Surgery Clinical Trial

Official title:
Intravenous Amino Acid Therapy for Kidney Protection in Cardiac Surgery: a Multi-centre Randomized Blinded Placebo Controlled Clinical Trial.

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03709264
Study type Interventional
Source Università Vita-Salute San Raffaele
Contact
Status Active, not recruiting
Phase Phase 3
Start date October 7, 2019
Completion date July 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05054179 - Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain Phase 2/Phase 3
Completed NCT04051021 - Non-Pharmacological Interventions on Patient Experience and Healthcare Utilization in Adult Cardiac Surgery Patients N/A
Recruiting NCT04604886 - The Consistency of Cardiac Output Measured by Pulmonary Artery Catheter and LiDCO in Cardiac Surgical Patients N/A
Recruiting NCT04075981 - Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF) Phase 3
Completed NCT04062396 - Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction N/A
Recruiting NCT04709705 - DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS) Phase 2/Phase 3
Not yet recruiting NCT05563662 - SURgical Registry of ENDocarditis EuRope
Withdrawn NCT03289104 - Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX N/A
Completed NCT02964026 - Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients N/A
Completed NCT03563196 - Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
Completed NCT04199039 - Effects of Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction N/A
Completed NCT02471001 - The Levels of Anaesthetics in Heart Muscle During Heart Surgery N/A
Completed NCT02325726 - RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery. N/A
Completed NCT01246947 - Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation N/A
Completed NCT01151254 - Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation N/A
Completed NCT00821262 - Sevoflurane in Cardiac Surgery Phase 4
Completed NCT00996099 - Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients N/A
Completed NCT00617955 - Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates N/A
Completed NCT00337805 - Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery Phase 2/Phase 3
Completed NCT00336466 - The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS) Phase 2