1. Variasi dari sampel sebaiknya dikurangi.
2. Diperlukan pengukuran nilai laktat secara serial untuk mendapat nilai prediktor yang lebih baik. (laktat diperiksa lebih dari 2 kali, misal laktat diperiksa saat jam ke-0, jam ke-24 dan jam ke-48)
3. Diperlukan sampel yang lebih banyak agar dapat menentukan nilai bersihan laktat arteri dari jam ke-0 ke ke-24 tersebut dapat digunakan sebagai prediktor untuk memprediksi mortalitas pasien sepsis berat di UPI
4. Dibutuhkan penelitian lebih lanjut untuk mencari faktor lain terhadap tidak adanya perbaikan laktat arteri jam ke-0 dan jam ke-24 pada pasien sepsis berat yang telah mendapat terapi sama berpedoman pada Surviving Sepsis Campaign.
Daftar Pustaka
1. Dean E. Schraufnagel, MD. sepsis. Breathing in America:Diseases, Progress,and Hope. USA : the American Thoracic Society, 2010, p. 227.
2. Angus DC, Linde-Zwirble WT, Lidicker J, et al. Epidemiology of severe sepsis in the United States:
analysis of incidence, outcome, and associated costs of care. [book auth.] Crit Care Med. Crit Care Med . s.l. : Crit Care Med , 2001, pp. 29:1303-1310.
3. Michael J. Breslow, MD and Badawi, and Omar. Maximizing Value From Outcome Prediction Scoring Systems. [book auth.] MD Michael J. Breslow and and Omar Badaw. Severity Scoring in the Critically Ill: Part 2. s.l. : CHEST, 2012, pp. 141(2):518-527.
4. Dellinger RP, Levy MM, Vincent JL et al. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock. [book auth.] Crit Care Med. Crit Care Med. s.l. : Crit Care Med, 2008, pp. 36:296-327.
5. Kaplan, Lewis J, Kellum, Jhon A. Jhon A : Initial pH, base deficit, lactate, anion gap, strong ion difference, strong ion gap predict outcome from major vascular injury. [book auth.] Crit Care Med. Crit Care Med. 2004 , pp. 32 : 1120-24.
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Serum lactate is associated with mortality in severe sepsis independent of organ failure and shock.
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25. Blow O, Magliore L, Claridge JA, Butler K, Young JS. The golden hour and the silver day: detection and correction of occult hypoperfusion within 24 hours improves outcome from major trauma. [book auth.] J Trauma. J Trauma. s.l. : J Trauma, 1999 Nov, pp. 47(5):964-9.
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34. RA., Balk. Severe sepsis and septic shock definitions, epidemiology, and clinical manifestations. . [book auth.] Crit Care Clin. 2000, pp. 16: 179–91.
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36. Bone RC, Balk RA, Cerra FB et al. American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference: definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. [book auth.] Chest. 1992, pp. 101: 1644–55.
37. Sunarmiasih, Sri. Sepsis : Pencetus gagal organ dan upaya penanggulannya. [book auth.]
Indonesian Journal of Intensive Care medicine. 2011, pp. 25-33.
38. JA., Russel. Management of sepsis. [book auth.] N Engl. J. Med. N Engl. J. Med. s.l. : N Engl. J. Med., 2006, pp. 1699-713., 355.
39. Albert J. Ruggieri, Richard J. Levy, MD, and Clifford S. Deutschman, MS, MD, FCCM. Mitochondrial Dysfunction and Resuscitation in Sepsis. [book auth.] Crit Care Clin. 2010, pp. 26(3): 567–575.
40. et.al., R. Phillip Dellinger MD. Surviving Sepsis Campaign: International Guidelines for management of Severe Sepsis and Septic shock 2012. [book auth.] Crit Care Med. 2013, pp. 41:580–
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41. Moviat M, van Haren F, van der Hoeven H. Conventional or physicochemical approach in intensive care unit patients with metabolic acidosis. [book auth.] Crit. Care. Crit. Care. s.l. : Crit. Care., 2003, pp.
R41-5.
42. Valenza F, Aletti G, Fossali T, Chevallard G, Sacconi F, Irace M, Gattinoni. Lactate as a marker of energy failure in critically ill patients : hypothesis. [book auth.] Crit Care. Crit Care. s.l. : Crit Care, 2005, pp. 9: 588-93.
43. Cohen RD, Simpson R. Lactate metabolism. [book auth.] Anesthesiology. Anesthesiology. 1975, pp. 43:661-73.
44. Wasserman K, Mcllroy MB. Detecting the threshold of anaerobic metabolism in cardiac patients during exercise. [book auth.] Am J Cardiol. Am J Cardiol. s.l. : Am J Cardiol, 1964, pp. 14:844-52.
45. GA., Brooks. Lactate shuttles in nature. [book auth.] Biochem soc Trans. Biochem soc Trans. s.l. : Biochem soc Trans, 2002, pp. 30:258-64.
46. Brooks GA, Dubouchad H, Brown M, Sicurello JP, Butz CE.. Role of mitochondrial lactate dehydrogenase and lactate oxidation in intracellular lactate shuttle. [book auth.] Proc Nat Acad Sci USA. Proc Nat Acad Sci USA. 1999, pp. 1129-34.
47. XM., Leverve. Lactic Acidosis. A New Insight? [book auth.] Minerva Anestesiol. Minerva Anestesiol.
s.l. : Minerva Anestesiol., 1999, pp. 65:205-9.
48. Leverve XM, Mustafa I. Lactate : a key metabolite in the intracellular metabolic interplay. . [book auth.] Crit Care. Crit Care. s.l. : Crit Care, 2002, pp. 6:284-5.
49. Luchette FA, Friend LA, Brown CC, Up Uturi RK, James JH. Increased skeletal muscle Na+, K+, ATPase activity as a cause of increased lactate production after hemorrargic shock. . [book auth.] J Trauma. J Trauma. s.l. : J Trauma, 1998, pp. 44: 796-801.
50. B., Levy. Lactate and shock state: the metabolic view. [book auth.] Curr Opinion Crit. Care. Curr Opinion Crit. Care. s.l. : Curr Opinion Crit. Care, 2006, pp. 12: 315-21.
51. Pellerin L, Magistretti PJ. Neuroenergetics: calling upon astrocyte to satisfy hungry neurons. [book auth.] Neuroscientist. s.l. : Neuroscientist, 2004, pp. 10: 53-62.
52. Joseph St, Heaton N, Potter D, Pernet A, Umpeleby MA, Amiel SA. Renal glucose production compensates for the liver during the anhepatic phase of liver transplantation. [book auth.] Diabetes.
s.l. : Diabetes, 2000, pp. 49: 450-6.
53. R, Bellomo. . Bench to bedside review: Lactate and the kidney. [book auth.] Crit Care. s.l. : Crit Care, 2002, pp. 6: 322-6.
54. Kline JA, Thornton LR, Lopaschuk GD, Barbee RW, Watts JA. Lactate improves cardiac efficiency after hemorrargic shock. [book auth.] Shock. s.l. : Shock , 2000, pp. 14: 215-21.
55. BA, Mizock. Lactic acidosi. [book auth.] Elbers PWG, eds. In Kellum JA. Stewart’s Textbook of Acid base 2nd ed. . USA : s.n., 2009, pp. 376-87.
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, 1992, pp. 80-93, 20.
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58. al., Asgar H Rishu et. Even Mild Hyperlactatemia is Associated with Increased Mortality in Critically Ill patients. [book auth.] Critical Care. 2013, p. 17: R197.
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[book auth.] Crit Care Med. s.l. : Crit Care Med, 1997, pp. 25: 46-51.
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LAMPIRAN
Lampiran 1
RIWAYAT HIDUP PENELITI
Nama : dr. Raka Jati Prasetya
Tempat / Tgl Lahir : Medan, 9 September 1984
Agama : Islam
Alamat rumah : Jl. Sei Muara no. 30/11 Medan Nama Ayah : Dr. Hasanul Arifin SpAn ,KAP ,KIC
Nama Ibu : Nazmellaily
Status : Menikah
Nama istri : Dr. Ade Andriany
Anak : Ryuga Jufan Praditya
Riwayat Pendidikan
1990-1996 : SD Kemala Bhayangkari I Medan
1996-1999 : SMPN I Medan
1999-2002 : SMA NEGERI 1 MEDAN
2002-2008 : Fakultas Kedokteran USU Medan
2009-sekarang : PPDS-1 Anestesiologi dan Terapi intensif FK-USU
Lampiran 2
JADWAL PERTAHAPAN PENELITIAN
1 Bimbingan Proposal Juli – November 2012 2 Seminar proposal Desember 2012
3 Perbaikan Proposal Desember 2012 4 Komisi Etika FK USU Desember 2012 5 Pengumpulan Data Mei-Agustus 2013 6 Pengolahan & Analisis Data September 2013 7 Bimbingan Hasil Penelitian September 2013 8 Seminar Akhir Penelitian September 2013
AGENDA Juli 2012
Lampiran 3
Lampiran 4
LEMBAR PENJELASAN MENGENAI PENELITIAN Bapak /Ibu/Saudara/i/adik-adik yth.
Saya, dr. Raka Jati Prasetya, saat ini saya menjalani program pendidikan dokter spesialis Anestesiologi dan Terapi Intensif Fakultas Kedokteran USU dan sedang melakukan penelitian yang berjudul :
“Uji diagnostik nilai bersihan laktat arteri pada jam ke-0 dan jam ke-24 sebagai prediktor mortalitas pada pasien sepsis berat di Unit Perawatan Intensif Rumah Sakit Haji Adam Malik Medan”
Penelitian ini bertujuan untuk mengetahui uji diagnostik laktat arteri pada jam ke-0 dan jam ke-24 dengan skor APACHE II sebagai prediktor mortalitas pada pasien sepsis di UPI RSU Haji Adam Malik Medan. Bila penelitian ini mendapatkan hasil sensitifitas yang tinggi maka laktat arteri jam ke-0 dan jam ke-24 dapat dijadikan sebagai prediktor mortalitas pada pasien sepsis berat di UPI. Adapun manfaat penelitian ini adalah, untuk mendapatkan alternatif lain sederhana, mudah dan murah sebagai prediktor pasien sepsis berat di UPI.
Penelitian ini dilakukan terhadap Bapak/Ibu/Saudara/SaudariAdik-adik dengan cara mengamati nilai laktat arteri pada jam ke-0 dan jam ke-24 dan skor APACHE II sepsis berat di UPI RSU Haji Adam Malik Medan. Kemudian pasien diamati selama 28 hari di UPI atau ruang rawat (bangsal) dan dievaluasi keadaan pasien ( hidup atau meninggal).
Prosedur peneltian ini adalah dengan cara mengambil darah arteri pada daerah pergelangan tangan atau sela lipat paha pada jam ke-0 dan jam ke-24. Dan efek samping yang dapat ditimbulkan adalah bengkak didaerah bekas suntikan pengambilan darah. Apabila terjadi hal-hal yang tidak diinginkan selama penelitian berlangsung maka pasien dapat menghubungi dr.Raka jati Prasetya (081397307977).
Kerja sama Bapak dan Ibu sangat diharapkan dalam penelitian ini. Bila masih ada hal-hal yang belum jelas menyangkut penelitian ini, setiap saat dapat ditanyakan pada peneliti dr.Raka Jati Prasetya.
Setelah memahami berbagai hal yang menyangkut penelitian ini, diharapkan Bapak/Ibu/Saudara/Sausari/Adik-adik yang telah terpilih sebagai sukarelawan pada penelitian ini, dapat mengisi lembaran persetujuan turut serta dalam penelitian yang telah disiapkan.
Medan 2013
Peneliti
dr. Raka Jati Prasetya
Lampiran 5
LEMBAR PERSETUJUAN SETELAH PENJELASAN (‘INFORMED CONSENT’)
Yang bertanda tangan di bawah ini:
Nama :
Umur :
Alamat :
Pekerjaan : Pendidikan :
Setelah memperoleh penjelasan sepenuhnya dan menyadari serta memahami tentang tujuan , manfaat, dan resiko yang mungkin timbul dalam penelitian berjudul:
“Uji diagnostik nilai bersihan laktat arteri pada jam ke-0 dan jam ke-24 sebagai prediktor mortalitas pada pasien sepsis berat di Unit Perawatan Intensif Rumah Sakit Umum Haji Adam Malik Medan.”
Dan mengetahui serta memahami bahwa subjek dalam penelitian ini sewaktu –waktu dapat mengundurkan diri dalam keikutsertaannya, dengan ini menyatakan ikut serta/mengikutsertakan anak /adik /ayah /ibu /suami /istri saya yang bernama………..dalam uji penelitian dan bersedia berperan serta dengan mematuhi semua ketentuan yang berlaku dan telah saya sepakati dalam penelitian tersebut di atas.
Medan,………2013
Mengetahui Yang Menyatakan
Penanggung Jawab Penelitian Peserta Uji Klinik
( dr.Raka Jati Prasetya ) (Nama Jelas:………)
Saksi Orang Tua/Wali Peserta Uji Klinik
(Nama Jelas:...) (Nama Jelas……….)
Lampiran 6
Lampiran 7
Kriteria Sepsis Berat : Sepsis + minimal 1 tanda dari hipoperfusi atau disfungasi organ
Areas of mottled skin
Capillary refilling time ≥ 3detik
Urin output < 0.5mL/kg dalam 1 jam atau renal replacement therapy Laktat > 2mmol/L
Perubahan kesadaran tiba-tiba atau electroencephalogram tidak normal Jumlah trombosit < 100000/mL atau disseminated intravascular coagulation Acute lung injury - acute respiratory distress syndrome Cardiac disfunction ( echocardiography )
Cara masuk ICU : pembedahan terencana pembedahan darurat medis
Menggunakan ventilator : ya tidak
Gagal ginjal akut : ya tidak
Insufisiensi organ kronis* : ya tidak
*INSUFISIENSI ORGAN KRONIS
Jika salah satu kategori di bawah dijawab “ya”
beri tambahan nilai +5 untuk pasien non operasi atau operasi emergensi
Hati - sirosis dengan PHT atau ensefalopali Kardivaskular - Angina klas IV atau saat istirahat atau aktivitas minimal
Pemeriksaan fisik terburuk dalam 24 jam : Pindah ke:
GCS : E ___ M___ V___ Tanggal : / / 20
Suhu tubuh : , °C Kondisi pindah :
Sistolik : - mmHg hidup
Diastolik : - mmHg meninggal
Tek. darah arteri : - mmHg lainnya : rata-rata(MAP)
((2 diastol + sistol) /3)
Laju nadi : - /menit Kondisi akhir di ruangan :
Laju nafas : - / menit hidup meninggal,tanggal / /20
Pemeriksaan laboratorium terburuk dalam 24 jam
FiO2 : , saat ambil AGD pH : ,
pO2 : mmHg pCO2 : mmHg
Nilai laktat : - Jam ke-0 mmol/l
Arteri - Jam ke-24 mmol/l
Natrium : mmol/l Kalium : , mmol/l Kreatinin : , mg/dl Hematokrit : %
Lekosit : . / mm3
Terapi dalam 24 jam :
Lampiran 8
RENCANA ANGGARAN PENELITIAN
Taksasi dana yang diperlukan selama penelitian 1. Bahan dan peralatan penelitian
Heparin Sodium (inviclot) = Rp 100.000,-
Fotocopy lembar penilaian skor APACHE II = Rp 15.000,-
Fotocopy lembar observasi pasien = Rp 15.000,- 2. Seminar usulan penelitian
Pengadaan bahan seminar 20 x Rp 10.000,- = Rp 200.000,- 3. Seminar hasil penelitian
Pengadaan bahan seminar hasil 20 x Rp 10.000,- = Rp 200.000,- 4. Tesis
Konsumsi tesis 50 x Rp 25.000,- = Rp 1.250.000,-
Cetak tesis 80 x Rp 20.000,- = Rp 1.600.000,- 5. Pemeriksaan Laktat 50 x Rp 300.000 ,- = Rp 15.000.000,-
6. Subtotal = Rp 18.380.000,-
7. Biaya tidak terduga ( 10% subtotal ) = Rp 1.838.000,-
Perkiraan biaya penelitian = Rp 19.518.000,-