Preventing Acute Kidney Injury (AKI) in Pediatric Patients
NCT ID: NCT03897335
Last Updated: 2022-04-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE3
Total Enrollment
80 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-02-07
Study Completion Date
2024-02-01
Brief Summary
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The purpose of this study is to compare the effects of peri-operative administration of Aminophylline versus Saline placebo in the preservation of renal function and the attenuation of renal injury in pediatric patients undergoing open heart surgery.
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Detailed Description
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Cardiac palliative/ correction surgeries in pediatric patients involve significant morbidity and mortality risks. Kidney function is frequently affected from cardiac surgery in these children. Studies identify the incidence of acute kidney injury (AKI) to be approximately 54% when defined by serum biomarkers (e.g. serum creatinine) and urine output criteria. The need for renal replacement therapy (RRT) for newborns and infants after cardiac surgery is reported as 2% to 17% in the literature. There are several reported risk factors for the development of AKI in this population. These are the complexities of the underlying heart disease and the surgical procedure, duration of cardiopulmonary bypass, functional single ventricle heart disease, circulatory arrest and low cardiac output syndrome in the post-operative period. AKI can cause worsening fluid overload compromising ventilation and lung function, predisposition to overwhelming infections and cytokine-mediated inflammatory state. The presence of AKI significantly increases the mortality that is associated with cardiac surgery in these very young patients, reported as high as 79% in the literature. There have been several reports suggesting that early intervention with AKI using renal replacement therapy (RRT) may improve patient mortality. Successful prevention strategies for AKI have not been reported for this high-risk population.
Adenosine has been demonstrated to regulate renal circulation and metabolism. It is a breakdown product of adenosine triphosphate/adenosine diphosphate (ATP/ADP) metabolism and accumulates in AKI. At baseline, the barely detectable renal parenchymal adenosine levels can increase to 10-100 times following an ischemic insult. These are typical seven trans-membrane spanning domains with a coupled G-protein at the intracellular end. Adenosine receptors are located ubiquitously in many tissues. Adenosine acts as a vasodilator in all other tissues but the renal parenchyma. The interaction of AT-II with adenosine converts adenosine to a vasoconstrictor in renal microvasculature. Adenosine acts on the A1 receptors (A1 R) in the afferent arterioles, causing reduced glomerular blood flow and glomerular filtration rate (GFR), as well as stimulating renin release from the kidney parenchyma. Adenosine plays an important role in generating the vasoconstrictive response in the renal vasculature to hypoxia and ischemia. Early interventions by blocking the actions of adenosine on A1 R may restore glomerular blood flow and recover GFR.
The study rationale is that Aminophylline and Theophylline are competitive non-selective inhibitors of adenosine. Therefore, even though aminophylline infusion (iv) has no effect on renal blood flow rate at baseline, it can ameliorate the decrease in renal blood flow rate following adenosine infusion. This property can improve renal function when the main mechanism of insult induces vasoconstriction. Both early and late administration of aminophylline protects renal function after ischemia-reperfusion injury in rats. Aminophylline has also been reported to successfully reverse newborn renal failure, prevent renal failure in perinatal asphyxia, and reverse acute kidney injury secondary to calcineurin induced nephropathy. Both theophylline and aminophylline have been used for prophylaxis of renal impairment during aorto-coronary bypass surgery in adults and the results have not been consistent for either a positive or negative effect. There have been no trials reported on the effect of aminophylline or theophylline to prevent or ameliorate acute kidney injury in children with congenital heart defects going through cardiac surgery.
Additionally, we are examining the components of serotonin biosynthesis to determine if these levels can act as markers of acute kidney injury in pediatric patients undergoing open heart surgery.
Adenosine has been demonstrated to regulate renal circulation and metabolism. It is a breakdown product of adenosine triphosphate/adenosine diphosphate (ATP/ADP) metabolism and accumulates in AKI. At baseline, the barely detectable renal parenchymal adenosine levels can increase to 10-100 times following an ischemic insult. These are typical seven trans-membrane spanning domains with a coupled G-protein at the intracellular end. Adenosine receptors are located ubiquitously in many tissues. Adenosine acts as a vasodilator in all other tissues but the renal parenchyma. The interaction of AT-II with adenosine converts adenosine to a vasoconstrictor in renal microvasculature. Adenosine acts on the A1 receptors (A1 R) in the afferent arterioles, causing reduced glomerular blood flow and glomerular filtration rate (GFR), as well as stimulating renin release from the kidney parenchyma. Adenosine plays an important role in generating the vasoconstrictive response in the renal vasculature to hypoxia and ischemia. Early interventions by blocking the actions of adenosine on A1 R may restore glomerular blood flow and recover GFR.
The study rationale is that Aminophylline and Theophylline are competitive non-selective inhibitors of adenosine. Therefore, even though aminophylline infusion (iv) has no effect on renal blood flow rate at baseline, it can ameliorate the decrease in renal blood flow rate following adenosine infusion. This property can improve renal function when the main mechanism of insult induces vasoconstriction. Both early and late administration of aminophylline protects renal function after ischemia-reperfusion injury in rats. Aminophylline has also been reported to successfully reverse newborn renal failure, prevent renal failure in perinatal asphyxia, and reverse acute kidney injury secondary to calcineurin induced nephropathy. Both theophylline and aminophylline have been used for prophylaxis of renal impairment during aorto-coronary bypass surgery in adults and the results have not been consistent for either a positive or negative effect. There have been no trials reported on the effect of aminophylline or theophylline to prevent or ameliorate acute kidney injury in children with congenital heart defects going through cardiac surgery.
Additionally, we are examining the components of serotonin biosynthesis to determine if these levels can act as markers of acute kidney injury in pediatric patients undergoing open heart surgery.
Conditions
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Acute Kidney Injury
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
1 Patient randomization groups
A) Group 1: Aminophylline pre CPB \& immediately post cardiopulmonary bypass (CPB)
B) Group 2: No aminophylline prophylaxis
A) Group 1: Aminophylline pre CPB \& immediately post cardiopulmonary bypass (CPB)
B) Group 2: No aminophylline prophylaxis
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Cohort 1 will consist of all children undergoing open heart surgery for congenital heart defects with or without circulatory arrest, and Cohort 2 will consist of Orthotopic heart transplantation patients. All subjects will be randomized 1:1 to aminophylline or saline placebo. Cohort 1 will be randomized using block-stratification with stratification factors age (neonate vs infant) and circulatory arrest (yes vs no). Age will be categorized as neonates (0 to \<28 days) and infants (28 days to \<1 year).
A total of 80 (60 in Cohort 1 and 20 in Cohort 2) participants are expected to be enrolled on this study.
A total of 80 (60 in Cohort 1 and 20 in Cohort 2) participants are expected to be enrolled on this study.
Study Groups
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Aminophylline pre CPB & immediately post CPB
Group Type
ACTIVE_COMPARATOR
Aminophylline
Intervention Type
DRUG
Aminophylline pre cardiopulmonary bypass and immediately post cardiopulmonary bypass. The dose will be Aminophylline 5 mg/kg/dose, max 350 mg slow infusion. The infusion rate duration will be standardized to 20 minutes. There will be no other aminophylline treatments for the first post-op five days.
Placebo
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
The placebo group will not receive any aminophylline treatments for the first post-op five days
Interventions
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Aminophylline
Aminophylline pre cardiopulmonary bypass and immediately post cardiopulmonary bypass. The dose will be Aminophylline 5 mg/kg/dose, max 350 mg slow infusion. The infusion rate duration will be standardized to 20 minutes. There will be no other aminophylline treatments for the first post-op five days.
Intervention Type
DRUG
Placebo
The placebo group will not receive any aminophylline treatments for the first post-op five days
Intervention Type
DRUG
Other Intervention Names
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Normal Saline
Eligibility Criteria
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Inclusion Criteria
Cohort 1
* All children undergoing open heart surgery for congenital heart defects with or without circulatory arrest
* Neonates (\<28 days old) and infants (\<1 years of age)
* Hypoplastic L heart syndrome or its variants.
* Coarctation with aortic arch hypoplasia.
* Interrupted aortic arch.
* TAPVR (Total anomalous pulmonary venous return)
* Patients with complex congenital heart defects
Cohort 2:
* Orthotopic heart transplantation patients.
* Patients ≤ 18 years of age
* Congenital heart defects
* Cardiomyopathy (Dilated/Hypertrophic/Restrictive/Left Ventricular Non-compaction)
* All children undergoing open heart surgery for congenital heart defects with or without circulatory arrest
* Neonates (\<28 days old) and infants (\<1 years of age)
* Hypoplastic L heart syndrome or its variants.
* Coarctation with aortic arch hypoplasia.
* Interrupted aortic arch.
* TAPVR (Total anomalous pulmonary venous return)
* Patients with complex congenital heart defects
Cohort 2:
* Orthotopic heart transplantation patients.
* Patients ≤ 18 years of age
* Congenital heart defects
* Cardiomyopathy (Dilated/Hypertrophic/Restrictive/Left Ventricular Non-compaction)
Exclusion Criteria
* Children under the age of 12 months undergoing bypass for any condition that is not categorized as congenital heart defect
* History of seizures
* History of significant tachyarrhythmia.
* History of seizures
* History of significant tachyarrhythmia.
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Le Bonheur Children's Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Umar S. Boston
Professor UTHSC
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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LeBonheur Children's Hospital
Memphis, Tennessee, United States
Site Status
RECRUITING
LeBonheur Children's Hospital
Memphis, Tennessee, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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1.KDIGO Clinical Practice Guideline for Acute Kidney Injury. Kidney Int. Suppl 2 ; 2012:1-138
Reference Type
BACKGROUND
Bojan M, Gioanni S, Vouhe PR, Journois D, Pouard P. Early initiation of peritoneal dialysis in neonates and infants with acute kidney injury following cardiac surgery is associated with a significant decrease in mortality. Kidney Int. 2012 Aug;82(4):474-81. doi: 10.1038/ki.2012.172.
Reference Type
BACKGROUND
11.Gouyon JB, Guignard JP. Glomerular filtration rates in neonates. In Oh w, Guignard JP, Baumgart S (Eds.): Nephrology and Fluid / Electrolyte Physiology, First edn (pp 79-96). Philadelphia: Saunders Elsevier 2008
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BACKGROUND
Linden J and Jacobson KA. Molecular biology and pharmacology of adenosine receptors. Cardiovascular Biology of Purines, 1-20 (Eds Burnstock G et al.) Dordrecht: Kluwer Academic Publishers.
Reference Type
BACKGROUND
Rigden SP, Barratt TM, Dillon MJ, De Leval M, Stark J. Acute renal failure complicating cardiopulmonary bypass surgery. Arch Dis Child. 1982 Jun;57(6):425-30. doi: 10.1136/adc.57.6.425.
Reference Type
RESULT
Sorof JM, Stromberg D, Brewer ED, Feltes TF, Fraser CD Jr. Early initiation of peritoneal dialysis after surgical repair of congenital heart disease. Pediatr Nephrol. 1999 Oct;13(8):641-5. doi: 10.1007/s004670050672.
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RESULT
Chan KL, Ip P, Chiu CS, Cheung YF. Peritoneal dialysis after surgery for congenital heart disease in infants and young children. Ann Thorac Surg. 2003 Nov;76(5):1443-9. doi: 10.1016/s0003-4975(03)01026-9.
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Boigner H, Brannath W, Hermon M, Stoll E, Burda G, Trittenwein G, Golej J. Predictors of mortality at initiation of peritoneal dialysis in children after cardiac surgery. Ann Thorac Surg. 2004 Jan;77(1):61-5. doi: 10.1016/s0003-4975(03)01490-5.
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RESULT
Pedersen KR, Povlsen JV, Christensen S, Pedersen J, Hjortholm K, Larsen SH, Hjortdal VE. Risk factors for acute renal failure requiring dialysis after surgery for congenital heart disease in children. Acta Anaesthesiol Scand. 2007 Nov;51(10):1344-9. doi: 10.1111/j.1399-6576.2007.01379.x.
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RESULT
Pedersen KR, Hjortdal VE, Christensen S, Pedersen J, Hjortholm K, Larsen SH, Povlsen JV. Clinical outcome in children with acute renal failure treated with peritoneal dialysis after surgery for congenital heart disease. Kidney Int Suppl. 2008 Apr;(108):S81-6. doi: 10.1038/sj.ki.5002607.
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RESULT
Gouyon JB, Guignard JP. Functional renal insufficiency: role of adenosine. Biol Neonate. 1988;53(4):237-42. doi: 10.1159/000242796.
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RESULT
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RESULT
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Rabb H. The promise of immune cell therapy for acute kidney injury. J Clin Invest. 2012 Nov;122(11):3852-4. doi: 10.1172/JCI66455. Epub 2012 Oct 24.
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RESULT
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RESULT
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RESULT
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RESULT
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Reference Type
RESULT
Nishiyama A, Inscho EW, Navar LG. Interactions of adenosine A1 and A2a receptors on renal microvascular reactivity. Am J Physiol Renal Physiol. 2001 Mar;280(3):F406-14. doi: 10.1152/ajprenal.2001.280.3.F406.
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RESULT
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RESULT
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RESULT
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Reference Type
RESULT
Other Identifiers
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Acute Kidney Injury
Identifier Type: -
Identifier Source: org_study_id
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