Tesis

Preliminary Analysis pada Uji Klinis: Efek Pemberian Gas Nitric Oxide dalam Cardiopulmonary Bypass pada Anak dengan Transposition of The Great Arteries yang Menjalani Operasi Arterial Switch terhadap Insiden Low Cardiac Output Syndrome = Preliminary Analysis in Randomized Controlled Trial: The Effect of Nitric Oxide Gas Administration in Cardiopulmonary Bypass in Children with Transposition of the Great Arteries Undergoing Arterial Switch Surgery on the Incidence of Low Cardiac Output Syndrome.

Latar belakang : Tindakan operasi Arterial Switch Operation (ASO) pada pasien dengan Transposition of The Great Arteries (TGA) memiliki angka morbiditas pascaoperasi yang tinggi. Pemberian nitric oxide (NO) pada mesin Cardiopulmonary Bypass (CPB) diduga dapat menurunkan respons inflamasi dan cedera iskemia dan reperfusi akibat operasi. Metode : Dilakukan penelitian dengan uji klinis tersamar acak ganda pada anak yang menjalani ASO, dengan dosis 20 ppm selama penggunaan CPB. Pascaoperasi akan dilakukan pencatatan hemodinamik, pengambilan sampel laboratorium, dan pencatatan komplikasi. Hasil : Total sebanyak 54 subjek yang dianalisis. Tidak terdapat hubungan antara pemberian NO terhadap insiden LCOS 1, 6, 12, 24, dan 48 jam pascaoperasi. Tidak terdapat hubungan antara pemberian NO terhadap insiden kematian (p=1,00). Tidak terdapat perbedaan bermakna antara pemberian NO dibandingkan dengan plasebo terhadap lama intubasi (p=0,129), lama rawat ICU (p=0,134), dan lama rawat rumah sakit (p=0,117). Tidak ditemukan perbedaan bermakna antara pemberian NO dan cedera ginjal akut (p=0,821). Terdapat hubungan antara pemberian NO terhadap balance cairan dua hari pascaoperasi (p=0,016) dan diuresis dua hari pascaoperasi (p=0,019). Kelompok NO mencapai balance cairan yang lebih negatif dan mendapatkan diuresis yang lebih tinggi dibandingkan kelompok plasebo. Tidak ditemukan hubungan antara pemberian NO terhadap kadar ureum dan kreatinin pada satu jam dan dua hari pascaoperasi. Simpulan : Terdapat hubungan antara pemberian NO dibandingkan dengan plasebo terhadap balance cairan dan diuresis dua hari pascaoperasi. Tidak ditemukan perbedaan lainnya secara klinis antara pemberian NO dibandingkan dengan plasebo.
Kata kunci : Nitric oxide, cardiopulmonary bypass, bayi, transposition of the great arteries, operasi bedah jantung


Background : The Arterial Switch Operation (ASO) for patients with Transposition of the Great Arteries (TGA) has a high postoperative morbidity rate. Administration of nitric oxide (NO) on the Cardiopulmonary Bypass (CPB) machine could decrease the inflammatory response and ischemia-reperfusion injury. Methods : A double-blind randomized clinical trial was conducted on children undergoing ASO, with a dose of 20 ppm during CPB. Postoperative hemodynamic recording, laboratory sample collection, and complication recording were performed. Results : A total of 54 subjects were analyzed. There was no association between the administration of NO and the incidence of LCOS at 1, 6, 12, 24, and 48 hours postoperatively. There was no association between the administration of NO and the incidence of mortality (p=1.00). There were no significant differences between the administration of NO and placebo in terms of intubation duration (p=0.129), ICU stay duration (p=0.134), and hospital stay duration (p=0.117). No significant differences were found between the administration of NO and the occurrence of acute kidney injury (p=0.821). There was an association between the administration of NO and fluid balance on the second postoperative day (p=0.016) and diuresis on the second postoperative day (p=0.019). The NO group achieved a more negative fluid balance and had higher diuresis compared to the placebo group. No association was found between the administration of NO and urea or creatinine levels at one hour and two days postoperatively. Conclusion : There is a relationship between NO administration compared to placebo on fluid balance and diuresis on the second postoperative day. No other clinical differences were found between NO administration and placebo.
Keywords : Nitric oxide, cardiopulmonary bypass, infant, transposition of the great arteries, cardiac surgery