Evaluation of Captopril and Nifedipine in Treatment of Hypertension in Children with Post-streptoccal Acute Glomerulonephritis with Hypertension- A Randomized Control Trial

This is a Randomized Control Trial study with 2 independent groups. We will be using a generic Captopril (CAPTOHEXAL (Registered Trademark) 12.5 COR) produced by Hexal AG, Germany for Captopril and a generic Nifedipine produced by Sai Mirra Innopharm from India. The Nifedipine, a 3,5-dimethyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate compound, is rapidly absorbed after oral administration. It is detectable in the serum after 10 – 15 minutes and the peak blood levels occur in approximately 30 minutes. Its half life is approximately 2 hours. It is metabolized mainly in the liver. The Captopril (CAPTOHEXAL (registered Trademark) 12.5 COR), is a (2S)-1-[(2S)-2-methyl-3-sulfanylpropanoyl] pyrrolidine-2-carboxylic acid compound. Following oral administration of Captopril, rapid absorption occurs and detectable in 15 minutes with peak blood levels at about one hour. After administration oral dose, the apparent elimination half-life for total radioactivity in blood is about 12 hours for the 12 to 48 hours time interval. It is primarily eliminated in the urine. The Nifedipine will be packed in a dosing of 5 mg each and the Captopril will be packed in 6.25mg each. Both medications will be wrapped in an aluminum foil. The packing of these medications into aluminum foil will be done by the pharmacist and should be identical so to eliminate bias. With this method, the caretaker, the patient and researcher will be blinded with the treatment. Block randomization will be done by a computer program. A list containing computer-generated assigned number then will be generated. The list will be kept by the pharmacist. The researcher or the first doctor in charge of patient will enroll the patient once consent is taken and inclusion criteria are fulfilled and the pharmacist will enroll the patient according to the randomization list. Before the patient is started on the treatment, parameters such as duration of illness before presentation, history of preceding infection, weight and height, blood pressure before treatment, renal profile, full blood count, complement levels, ASOT and anti- DNase B level will be recorded. The Nifedipine and Captopril will be titrated according to response. The dosage of Nifedipine and Captopril given will be based on weight and the age of the patient. This will ensure that the given drug will fall onto the therapeutic ranges of each medication. After the medication is initiated, the blood pressure will be monitored 1/2 hour, 1 hour, 4 hours, 8 hours, 12 hours and 24 hours after administration on day one and subsequently daily (early morning at 8.00 am) during the course of the treatment, until the patient is discharged. Blood pressure will be taken in supine position and using a single automated BP monitoring device (DINAMAP (Registerd Trademark) with appropriate cuff size using according to the NHBPEP (National High Blood Pressure Education Program) Working Group on High Blood Pressure in Children and Adolescence 2004 recommendations. Additional antihypertensive can be used to control the blood pressure if it is not controlled after 3 hours of starting the treatment and if there is a risk of patient developing hypertensive encephalopathies. Only Frusemide can be used for this and can be given as per needed basis. If the risk of hypertensive encephalopathy in inevitable, patient will be started on intravenous antihypertensive, i.e Sodium Nitroprusside and patient will be excluded from the study. Apart from blood pressure, we will monitor the Blood Urea, Creatinine, [UK/(UNa+K)] Ratio, and Beta-2 Microglobulin, on the third day of the treatment to compare the levels between pretreatment and the post treatment difference. Statistical analysis will be done by using SPSS software version 12.0.1, with results of the blood pressure, total duration of medication, hospitalization and normalization of BP will be explained in means and compared. It is then tested with Independent Student T- test for confirmation of the difference of blood pressure means. As for the duration of blood pressure normalization and duration of hospital stay, Mann- Whitney test will be used for confirmation.