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Trial record 7 of 20 for:    Cystatin | Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

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
Sponsor:
Information provided by (Responsible Party):
Ali Mirza Onder, MD, Le Bonheur Children's Hospital

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
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)
Masking Description:

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.

Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Aminophylline pre CPB & immediately post CPB Drug: 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.

Placebo Comparator: Placebo Drug: Placebos
The placebo group will not receive any aminophylline treatments for the first post-op five days




Primary Outcome Measures :
  1. 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.

  2. Concentration of Delta serum cystatin C [ Time Frame: 12 hours post CPB ]
    Delta serum cystatin C

  3. Concentration of Delta serum cystatin C [ Time Frame: 24 hours post CPB ]
    Delta serum cystatin C

  4. 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


  5. Urine output during post op [ Time Frame: first 12 hours and then daily till post op 3 days ]
    Urine output during post op


Secondary Outcome Measures :
  1. Time to extubation (hours) [ Time Frame: during hospitalization, up to 8 days ]
    Time to extubation (hours) number of hours post surgery

  2. 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

  3. Time to discharge from cardiovascular intensive care unit (CVICU) (days) [ Time Frame: during hospitalization, approximate 5 days ]
    Time to discharge from CVICU (days)

  4. Duration of hospital stay (Days). [ Time Frame: during hospitalization, approximate 8 days ]
    Duration of hospital stay (Days).

  5. Dialysis requirement (yes/no) [ Time Frame: during hospitalization, approximate 5 days ]
    Dialysis requirement (yes/no)

  6. Time to return to preoperative weight. [ Time Frame: during hospitalization, approximate 8 days ]
    Time to return to preoperative weight.

  7. 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

  8. 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

  9. Peritoneal dialysis catheter output. [ Time Frame: during hospitalization, up to 8 days ]
    Peritoneal dialysis catheter output through study completion

  10. Transfusion requirements intraoperatively and postoperatively [ Time Frame: during hospitalization, up to 8 days ]
    Transfusion requirements intraoperatively and postoperatively through study completion



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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • Congenital heart defects
  • Cardiomyopathy (Dilated/ hypertrophic)

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Ali M Onder, MD 304-282-8550 aonder@uthsc.edu
Contact: Kerry Moore, RN 901-287-6871 kerry.moore@lebonheur.org

Locations
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United States, Tennessee
LeBonheur Children's Hospital Recruiting
Memphis, Tennessee, United States, 38103
Contact: Ali M Onder, MD    901-287-5437    aonder@uthsc.edu   
Contact: Kerry Moore, RN    901-287-6871    kerry.moore@lebonheur.org   
Sponsors and Collaborators
Le Bonheur Children's Hospital

Publications of Results:

Other Publications:
1.KDIGO Clinical Practice Guideline for Acute Kidney Injury. Kidney Int. Suppl 2 ; 2012:1-138
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
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.

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Responsible Party: Ali Mirza Onder, MD, Associate Professor UTHSC, Le Bonheur Children's Hospital
ClinicalTrials.gov Identifier: NCT03897335     History of Changes
Other Study ID Numbers: Acute Kidney Injury
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Aminophylline
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Protective Agents