Acute Kidney Injury

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.

Aminophylline

The placebo group will not receive any aminophylline treatments for the first post-op five days

Placebos

LeBonheur Children's Hospital

Preventing Acute Kidney Injury (AKI) in Neonates

The Effect of Aminophylline on Preventing Acute Kidney Injury in Neonates and Infants With Congenital Heart Disease Undergoing Open Heart Surgery

1 Delta urinary NGAL at 6 hours post cardiopulmonary (CPB) and Delta plasma NGAL at 2 hours post CPB.

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

Time to extubation (hours) number of hours post surgery

Time to chest closure (hours) from start time of incision to chest closure during procedure

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 through study completion

Transfusion requirements intraoperatively and postoperatively through study completion

Ali Mirza Onder, MD

Associate Professor UTHSC

Le Bonheur Children's Hospital

1 Patient randomization groups
A) Group 1: Aminophylline pre CPB & immediately post cardiopulmonary bypass (CPB)
B) Group 2: No aminophylline prophylaxis

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.

Administer a single dose of placebo (yellow corn meal in a capsule, gelatin ) in Normoxic Conditions.
Following a minimum of 7 days a single dose placebo will be administered (yellow corn meal in a gelatin capsule) in Hypoxic conditions.

Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Normoxic Conditions.
Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Hypoxic conditions.

Administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions.
Following a minimum of 7 days administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions.

Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions.(Aminophylline+Methazolamide)
Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions.

Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo: Hypoxia

Placebo

Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia

Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide: Hypoxia

Methazolamide

Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia

Aminophylline + Methazolamide

Total

Sex: Female, Male

Region of Enrollment

Body Mass Index

Body Fat %

Fat Mass

Fat Free Mass

maximal oxygen uptake (VO2max)

After exercising on a stationary cycle ergometer for 30 minutes at a resistance of 100 watts, research participants will complete an exercise time trial. The time taken to cycle a distance equivalent to 7.75 miles will be recorded. On a separate day the experiment will be repeated in hypoxia. It is expected that the time taken to cycle a distance equivalent to 7.75 miles will be longer in hypoxia compared to normoxia. One of the goals of this research is to determine if the hypoxia-mediated performance decrement can be decreased with one of our pharmacological interventions.

Normoxia Placebo

Hypoxia Placebo

Normoxia Aminophylline

Hypoxia Aminophylline

Normoxia Methazolamide

Hypoxia Methazolamide

Methazolamide combined with Aminophylline: single dose normoxia

Normoxia Methazolamide/Aminophylline

Methazolamide combined with Aminophylline: single dose hypoxia

Hypoxia Methazolamide/Aminophylline

Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen).

Overall Study

Christopher Bell, Ph.D.

Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo Hypoxia
.

Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide Hypoxia

Physiological Function in Low Oxygen Environment

Aminophylline+Methazolamide

Department of Health and Exercise Science, Colorado State University

Initial Safety Trial For Treatments Under Investigation In Current Study

Colorado State University, Dept. of Health and Exercise Science

Rapid Acclimatization to Hypoxia at Altitude

Christopher Bell

Associate Professor

Colorado State University

Defense Advanced Research Projects Agency

University of Colorado, Denver

Aminophylline, Methazolamide, Aminophylline and Methazolamide

Methazolamide, Aminophylline, Aminophylline and Mathazolamide

Treatment 1, Treatment 2, Treatment 3
Treatment 1 : Aminophylline dosage form-tablet dosage-500mg
Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally

Sequence A

Treatment 2, Treatment 1, Treatment 3
Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally
Treatment 2 : Methazolamide dosage form-tablet dosage-250mg

Sequence B

Gender

BMI = <=18-30 kg/m2

Adverse event data was evaluated for incidence and severity for 6 days.

Adverse Events.

First Intervention (1 Day)

Washout (1 Day)

Second Intervention (1 Day)

Third Intervention (1 Day)

Discharge (1 Day)

Gary Luckasen, M.D.

Aminophylline (1 Day) Washout (1 Day) Methazolamide (1 Day) Washout (1 Day) Both Aminophylline & Methazolamide (1 Day) Discharge (1 Day)

Arm A

Methazolamide (1 Day) Washout (1 Day) Aminophylline (1 Day) Washout (1 Day) Both Aminophylline & Methazolamide (1 Day) Discharge (1 Day)

Arm B

Mountain Sickness

Aminophylline dosage form-tablet dosage-500mg

Methazolamide dosage form-tablet dosage-250mg

Aminophylline 500mg orally and Methazolamide 250mg orally

Aminophylline and Methazolamide

Medical Center of the Rockies

Safety Evaluation of Aminophylline and Methazolamide

The Safety Evaluation of Aminophylline and Methazolamide When Administered Orally Alone and in Combination to Healthy Volunteers

Gary J. Luckasen, MD

Prinicipal Investigator

Poudre Valley Health System

Anaesthesia

receive intravenous injection of 0.2 mL/kg of saline 0.9%L [group P]. All study solutions were injected within 1 min at T0 after discontinuation of sevoflurane. No stimulation was applied to patients during this period.

Placebo [group P]

receive intravenous injection of 0.2 mL/kg of aminophylline 10 mg/mL [group A2]. All study solutions were injected within 1 min at T0 after discontinuation of sevoflurane. No stimulation was applied to patients during this period.

0.2 mL/kg of aminophylline 10 mg/mL [group A2]

receive intravenous injection of 0.2 mL/kg of aminophylline 15 mg/mL [group A3]. All study solutions were injected within 1 min at T0 after discontinuation of sevoflurane. No stimulation was applied to patients during this period.

0.2 mL/kg of aminophylline 15 mg/mL [group A3]

receive intravenous injection of 0.2 mL/kg of aminophylline 20 mg/mL [group A4]. All study solutions were injected within 1 min at T0 after discontinuation of sevoflurane. No stimulation was applied to patients during this period.

0.2 mL/kg of aminophylline 20 mg/mL [group A4]

receive intravenous injection of 0.2 mL/kg of aminophylline 25 mg/mL [group A5]. All study solutions were injected within 1 min at T0 after discontinuation of sevoflurane. No stimulation was applied to patients during this period.

0.2 mL/kg of aminophylline 25 mg/mL [group A5]

receive intravenous injection of 0.2 mL/kg of doxapram 5 mg/mL [group D]. All study solutions were injected within 1 min at T0 after discontinuation of sevoflurane. No stimulation was applied to patients during this period.

Doxapram 1 mg/kg [group D]

King Faisal University

Aminophylline and Cognitive Function After Sevoflurane Anaesthesia

Aminophylline Improves Early Postoperative Cognitive Recovery After Sevoflurane Anaesthesia: A Dose-Dependent Study

The SOMCT is a patient-based test designed to assess cognitive function in terms of level of orientation, memory, and concentration.

aminophylline/hypoxia

Preventing Acute Kidney Injury (AKI) in Neonates

Rapid Acclimatization to Hypoxia at Altitude

Safety Evaluation of Aminophylline and Methazolamide

Aminophylline and Cognitive Function After Sevoflurane Anaesthesia

Aminophylline in Bradyasystolic Cardiac Arrest

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