- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03331146
Nitrite Infusion in High Risk Patients Undergoing Cardiopulmonary Bypass
Randomized, Controlled, Double-blinded Pilot Study: Nitrite Infusion in High Risk Patients Undergoing Cardiopulmonary Bypass
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35249
- UAB Department of Anesthesiology and Perioperative Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients CCFS score ≥ 6 (Table 1)
- Patients admitted to UAB cardiac intensive care unit (CICU) following elective cardiac surgery with cardiopulmonary bypass under general endotracheal anesthesia
- 19 years old
- Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73 m2
Exclusion Criteria:
- Prisoners directly admitted from a correctional facility.
- Children < 19 years or under 50 kg body weight if age is unknown.
- Patients enrolled in a concurrent ongoing interventional, randomized clinical trial.
- Patients with end stage renal disease or preexisting GFR <30 mL/min/1.73 m2 or need for dialysis. 34
- Patients with end stage heart disease on the cardiac transplant list.
- Patients undergoing procedures without the use of CPB
- All transplant patients.
- Patients on ventricular assist devices.
- Patients undergoing emergency procedures.
- Patients with glucose 6-dehydrogenase deficiency
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control group
saline infusion will be administered after induction of general anesthesia
|
A placebo (saline infusion) will be administered after induction of general anesthesia.
Sodium nitrite infusion at a 267 mcg/kg/hr.
will start after induction of general anesthesia via a dedicated IV line for 6 hrs.
Other Names:
|
Active Comparator: Sodium Nitrite
sodium nitrite will start after induction of general anesthesia via a dedicated IV line for 6 hrs.
|
A placebo (saline infusion) will be administered after induction of general anesthesia.
Sodium nitrite infusion at a 267 mcg/kg/hr.
will start after induction of general anesthesia via a dedicated IV line for 6 hrs.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nitrite Metabolome Levels
Time Frame: baseline to 73 hrs post-operatively
|
Measuring nitrite, nitrate, and nitrosothiols levels
|
baseline to 73 hrs post-operatively
|
Biomarkers of Hemolysis
Time Frame: baseline to 73 hrs post-operatively
|
Measuring hemolysis indicators heme, Hb, hemopexin, and hemopectin
|
baseline to 73 hrs post-operatively
|
Biomarkers of Kidney Injury
Time Frame: baseline to 73 hrs post-operatively
|
Measuring kidney injury indicators creatine, neutrophil-associated gelatinase, lipocalin (NGAL)
|
baseline to 73 hrs post-operatively
|
Cell Cycle Stress
Time Frame: baseline to 73 hrs post-operatively
|
Measuring cell cycle arrest biomarkers TIMP-2, IGFBP-7
|
baseline to 73 hrs post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biomarkers of Hepatic injury
Time Frame: baseline to 24 hours post-operatively
|
Measuring serum AST and ALT
|
baseline to 24 hours post-operatively
|
Biomarkers of Kidney Injury
Time Frame: baseline to 24 hours post-operatively
|
Measuring kidney injury indicators creatine, neutrophil, lipocalin (NGAL)
|
baseline to 24 hours post-operatively
|
Cell Cycle Stress
Time Frame: baseline to 24 hours post-operatively
|
Measuring cell cycle arrest biomarkers TIMP-2, IGFBP-7
|
baseline to 24 hours post-operatively
|
Biomarkers of Myocardial Injury
Time Frame: baseline to 24 hours post-operatively
|
Measuring myocardial injury indicators troponin and CKMB
|
baseline to 24 hours post-operatively
|
Urine Output
Time Frame: baseline to 73 hrs post-operatively
|
Measuring total urine output
|
baseline to 73 hrs post-operatively
|
Vasopressors Usage
Time Frame: baseline to 73 hrs post-operatively
|
Percentage of vasopressor usage between the control and intervention
|
baseline to 73 hrs post-operatively
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ahmed F Zaky, MD, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1709284471
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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