Preventing Acute Kidney Injury (AKI) in Neonates (AKI)
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|ClinicalTrials.gov Identifier: NCT03897335|
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
The purpose of the study is compare the effects of peri-operative administration of aminophylline (non-specific adenosine receptor antagonist) versus saline placebo in the preservation of renal function and the attenuation of renal injury in newborns, and young infants following cardiac palliative/correction surgery.
The study rationale is 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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Injury||Drug: Aminophylline Drug: Placebos||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
1 Patient randomization groups
A) Group 1: Aminophylline pre CPB & immediately post cardiopulmonary bypass (CPB)
B) Group 2: No aminophylline prophylaxis
|Masking:||Triple (Participant, Care Provider, Investigator)|
There will be 1:1 randomization according to stratification.
That is subjects with circulatory arrest and non-circulatory arrest will be
Separately randomized 1:1 to intervention and placebo.
The randomization will be designed on RedCAP and the entire clinical team will
Be blinded to the treatment.
The initial subject goal will still be 48 patients, 24 intervention (12 circulatory arrest and 12 non-circulatory arrest)
and 24 placebo.
|Official Title:||The Effect of Aminophylline on Preventing Acute Kidney Injury in Neonates and Infants With Congenital Heart Disease Undergoing Open Heart Surgery|
|Actual Study Start Date :||February 7, 2019|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||February 1, 2022|
|Active Comparator: Aminophylline pre CPB & immediately post CPB||
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 Comparator: Placebo||
The placebo group will not receive any aminophylline treatments for the first post-op five days
- Concentration of Delta urinary neutrophil gelatinase-associated lipocalin (NGAL) [ Time Frame: at 2 hours post CPB. ]1 Delta urinary NGAL at 6 hours post cardiopulmonary (CPB) and Delta plasma NGAL at 2 hours post CPB.
- Concentration of Delta serum cystatin C [ Time Frame: 12 hours post CPB ]Delta serum cystatin C
- Concentration of Delta serum cystatin C [ Time Frame: 24 hours post CPB ]Delta serum cystatin C
- Acute kidney injury stage [ Time Frame: max point within post CPB 72 hours ]
Acute kidney injury stage Pediatric modified Acute Kidney Injury Network criteria (pAKIN) AKI Stage I-<0.5mL (milliliter)/kg/hour for 8 hours AKI Stage II-<0.5mL/kg/hour for 16 hours AKI Stage III-<0.3mL/kg/hour for 24 hours OR Anuria for 16 hours
Using serum creatinine and AKIN criteria
- Urine output during post op [ Time Frame: first 12 hours and then daily till post op 3 days ]Urine output during post op
- Time to extubation (hours) [ Time Frame: during hospitalization, up to 8 days ]Time to extubation (hours) number of hours post surgery
- Time to chest closure (hours) [ Time Frame: during hospitalizaiton, up to 3 days ]Time to chest closure (hours) from start time of incision to chest closure during procedure
- Time to discharge from cardiovascular intensive care unit (CVICU) (days) [ Time Frame: during hospitalization, approximate 5 days ]Time to discharge from CVICU (days)
- Duration of hospital stay (Days). [ Time Frame: during hospitalization, approximate 8 days ]Duration of hospital stay (Days).
- Dialysis requirement (yes/no) [ Time Frame: during hospitalization, approximate 5 days ]Dialysis requirement (yes/no)
- Time to return to preoperative weight. [ Time Frame: during hospitalization, approximate 8 days ]Time to return to preoperative weight.
- Inotropic score [ Time Frame: at 5 days post operative ]Inotropic score Calculation of Inotropic score (IS) and Vasoactive inotropic score (VIS). IS(a) = dopamine dose (lg/kg/min) ? dobutamine dose (lg/kg/min) ? 100 9 epinephrine dose (lg/kg/min) VIS(b) = IS ? 10 9 milrinone dose (lg/kg/ min) ? 10,000 9 vasopressin dose (U/kg/ min) ? 100 9 norepinephrine dose (lg/kg/min) IS inotrope score, VIS vasoactive-inotropic score
- Inotropic score [ Time Frame: at 7 days post operative ]Inotropic score Calculation of Inotropic score (IS) and Vasoactive inotropic score (VIS). IS(a) = dopamine dose (lg/kg/min) ? dobutamine dose (lg/kg/min) ? 100 9 epinephrine dose (lg/kg/min) VIS(b) = IS ? 10 9 milrinone dose (lg/kg/ min) ? 10,000 9 vasopressin dose (U/kg/ min) ? 100 9 norepinephrine dose (lg/kg/min) IS inotrope score, VIS vasoactive-inotropic score
- Peritoneal dialysis catheter output. [ Time Frame: during hospitalization, up to 8 days ]Peritoneal dialysis catheter output through study completion
- Transfusion requirements intraoperatively and postoperatively [ Time Frame: during hospitalization, up to 8 days ]Transfusion requirements intraoperatively and postoperatively through study completion
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): NCT03897335
|Contact: Ali M Onder, MDfirstname.lastname@example.org|
|Contact: Kerry Moore, RNemail@example.com|
|United States, Tennessee|
|LeBonheur Children's Hospital||Recruiting|
|Memphis, Tennessee, United States, 38103|
|Contact: Ali M Onder, MD 901-287-5437 firstname.lastname@example.org|
|Contact: Kerry Moore, RN 901-287-6871 email@example.com|