Acute Kidney Injury Clinical Trial
Official title:
Effects of Aminophylline on Renal Function and Urine Volume Acute Kidney Injury Patient
This study evaluates the effects of aminophylline on serum creatinine and urine volume of AKI Patient.Half of participants will receive aminophylline and furosemide in combination,while the other half will receive only furosemide.
Acute kidney injury (AKI) is a sudden perturbation of kidney function that is frequently
associated with high morbidity and mortality rates . A diagnostic time limit of 48 hours was
recently introduced to ensure early diagnosis, management and prevention of progression to
irreversible renal function loss . Furthermore, early AKI biomarkers that can ensure prompt
diagnosis have been identified. When these biomarkers become widely available to clinical
practice, informed therapeutic interventions capable of aborting disease progression,
morbidity and mortality multiplication can be applied . In the injured kidney, adenosine is
released endogenously from the macula densa causing vasoconstriction of the renal afferent
arterioles via the adenosine A1receptor as well as vasodilatation of the renal efferent
arterioles via the adenosine A2 receptor; thereby reducing the renal blood flow and
glomerular perfusion pressure leading to ischemic kidney injury . One measure that has been
tried with the objective of achieving better AKI outcome is the use of aminophylline (an
ethylenediamine coupled theophylline) . Aminophylline is converted to theophylline in the
human body, which in turn vasodilates the renal afferent arterioles through competitive
inhibition of adenosine on the adenosine A1 receptor.
Aminophylline and theophylline, methylxanthine nonselective adenosine receptor antagonists,
have been effective in the management of AKI in certain clinical scenarios including heart
failure, calcineurin inhibitor toxicity, and perinatal asphyxia. In the kidney, adenosine
constricts the afferent arteriole and decreases glomerular blood flow; adenosine receptor
blockade mitigates this vasoconstriction. Aminophylline also inhibits phosphodiesterase at
higher concentrations, which leads to increased urine output.
Eligible subjects included all patients more than 18 years old with acute kidney injury in
ICU. To ensure the safest oversight for the duration of the study drug infusion, the
investigators only approached patients for consent if participants' ICU stay would likely be
at least 72 hours . Patients were recruited in the preoperative clinic or in the inpatient
ward/ICU; the nature of the consent process for this interventional drug trial necessitated
that all procedures were elective or scheduled. Because aminophylline has been associated
with tachycardia and seizures at high serum levels, and its metabolism may be affected by
liver or thyroid dysfunction and sepsis, the investigators selected the following exclusion
criteria: history of tachyarrhythmias, seizures, coagulopathy (international normalized
ratio > 1.5 while not taking warfarin),or hypothyroidism. Study investigators or research
nurses recruited participants; written, informed consent was signed by each patient or
guardian.
The treatment group received aminophylline 5 mg/kg IV load over 30 minutes, followed by 0.5
mg/kg IV every hour, for 72 hours .The control group received placebo bolus followed by IV
infusions of normal saline (0.9%) every hour (matched by volume and appearance to the
treatment group), for 72 hours.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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