Acute Kidney Injury Clinical Trial
Official title:
Randomized, Controlled, Double-blinded Pilot Study: Nitrite Infusion in High Risk Patients Undergoing Cardiopulmonary Bypass
The main objective of this study is to evaluate the efficacy of intravenous sodium nitrite compared with placebo in reducing the occurrence of CSA-AK as diagnosed by KDIGO criteria during the first 72 hrs after cardiac surgery in high-risk patients undergoing cardiac surgery. Secondary objectives are to determine whether IV sodium nitrite achieves adequate pharmacokinetics (PK) in patients undergoing cardiac surgery with the use of CPB.
Acute kidney injury is one of the most untoward consequences of cardiac-surgery with the use
of CPB. As such it is associated with a high mortality and morbidity and health care expense.
Unfortunately, currently, there is no effective preventive or treatment strategy for cardiac
surgery-associated (CSA) AKI other than renal replacement therapy.
It is postulated that a major mechanism of CSA-AKI is created by the ischemia reperfusion
injury (IRI) resulting from aortic cross clamping and unclamping. This creates a cascade of
events culminating in inflammation, microvascular dysfunction and tubular cell maladaptation
and eventually renal tissue damage. Current treatment modalities that target the
microcirculation such as blood pressure and cardiac output fails to prevent renal
abnormalities and as such may be deleterious to the renal tissue microcirculation. The PI
hypothesizes that a therapeutic strategy that limits IRI such as the administration of
inhaled nitric oxide (NO) or sodium nitrite (NaNO2) would ameliorate CSA-AKI by limiting
inflammatory injury to the kidney.
The anion nitrite (NO2-) releases NO in biological systems and has been demonstrated to
inhibit IR injury in the heart, liver and kidneys created by various pathologic states1-3 and
improve outcomes in patients with acute myocardial infarction, in patients with pulmonary
hypertension and is the putative active mediator of protection in liver-transplantation
patients receiving inhaled nitric oxide4.
The objective of this study is to determine whether the NO donor, nitrite will prevent I/R
injury in patients at high risk of development of CSA-AKI undergoing open-heart surgery with
cardiopulmonary bypass.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05538351 -
A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury
|
||
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Completed |
NCT03938038 -
Guidance of Ultrasound in Intensive Care to Direct Euvolemia
|
N/A | |
Recruiting |
NCT05805709 -
A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial
|
N/A | |
Recruiting |
NCT05318196 -
Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
|
||
Recruiting |
NCT05897840 -
Continuous Central Venous Oxygen Saturation Measurement as a Tool to Predict Hemodynamic Instability Related to Renal Replacement Therapy in Critically Ill Patients
|
N/A | |
Recruiting |
NCT04986137 -
Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Cirrhosis
|
||
Terminated |
NCT04293744 -
Acute Kidney Injury After Cardiac Surgery
|
N/A | |
Completed |
NCT04095143 -
Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
|
||
Not yet recruiting |
NCT06026592 -
Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
|
||
Not yet recruiting |
NCT06064305 -
Transcriptional and Proteomic Analysis of Acute Kidney Injury
|
||
Terminated |
NCT03438877 -
Intensive Versus Regular Dosage For PD In AKI.
|
N/A | |
Terminated |
NCT03305549 -
Recovery After Dialysis-Requiring Acute Kidney Injury
|
N/A | |
Completed |
NCT05990660 -
Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery
|
N/A | |
Completed |
NCT04062994 -
A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
|
||
Terminated |
NCT02860130 -
Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)
|
Phase 3 | |
Completed |
NCT06000098 -
Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy
|
||
Not yet recruiting |
NCT05548725 -
Relation Between Acute Kidney Injury and Mineral Bone Disease
|
||
Completed |
NCT02665377 -
Prevention of Akute Kidney Injury, Hearttransplant, ANP
|
Phase 3 | |
Terminated |
NCT03539861 -
Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients
|
N/A |