]>
IRCT20150825023760N8 IRCT 2019-03-12 Zanjan University of Medical Sciences Effects of N-acetyl cysteine on the improvement of cardiopulmonary and renal functions Effects of N-acetyl cysteine on the improvement of cardiopulmonary and renal functions after cardiopulmonary bypass in patients with coronary artery bypass graft 2013-12-10 anticipated 50 Complete https://irct.ir/trial/29287 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study patients who met inclusion criteria were divided into intervention and control group by simple randomization method.This method is one of basic methods for sampling in experimental studies, and frequently is used in studies with a few sample size.For randomization between two groups, random numbers table is used.In this study fifty patients with diagnosis of CABG in Heart surgery critical care unit of Ayatollah Mousavi hospital after matching for demographic data’s and Apache 2 Score we’re divided into intervention group and control group by randomization with computerized random number tables.Fifty random numbers were extracted of computer by using random number table and for example 24th sample was set in intervention group and 14th sample was set in control group and this process was performed until end of the study. N/A Cardiac coronary arterial disease. Intervention 1: Intervention group: After induction, a central venous line was inserted and first blood sample (pre-CPB time) was obtained. After this stage, the NAC group received 100 mg/kg NAC. Intervention 2: Control group: the control group received normal saline one hour before initiating CPB. Yes - There is a plan to make this available What will be shared: After completing the study, there is a plan to share non-identifiable individual data of the participants, the study protocol, the statistical analysis of the data, the informed consent form patents, clinical reports, analysis codes, and data coding systems (Dictionary). When: The start of the access period to the data of this study will be from mid-2019 and approximately 6 months after the publication of the results To whom: The data from this study will be available to all people who can play a role in caring for CABG patients, such as families, and healthcare workers. Conditions: The researcher tend to use data to improve patients, especially CABG patients. Where to obtain: To receive information anyone can be use the following email: jamshidianes@zums.ac.ir How to obtain: The data will be sent to the applicants after her introduction and the reason for the need for data. Comments:
public Mohammadreza Jamshidi
Mousavy Hospital, Sobotie Blvd, Zanjan
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0000 jamshidianes@zums.ac.ir Zanjan University of Medical Sciences scientific Mohammadreza Jamshidi
Zanjan,Gavazang Ave ,Mousavy Hospital
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0000 jamshidianes@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria were patients with age 25-75 years undergoing cardio pulmonary bypass (CPB) for coronary artery bypass graft(CABG). 25 years 75 years Both Exclusion criteria were patients for emergency coronary artery bypass graft(CABG) Redo CABG The intubation time after surgery for more than >10 hours Severe hemorrhage during coronary artery bypass graft (CABG) I27.9 I26-I28 Treatment - Drugs Placebo Intervention group: After induction, a central venous line was inserted and first blood sample (pre-CPB time) was obtained. After this stage, the NAC group received 100 mg/kg NAC. Control group: the control group received normal saline one hour before initiating CPB. The ratio of partial pressure arterial oxygen and fraction of inspired oxygen(Pao2/Fio2). Timepoint: The time points of blood sampling were after induction, before the administration of N-acetylcysteine (NAC) (pre-CPB)(Time 1) as baseline, one hour after CPB (on-CPB)(Time 2) , and one hour after that the patients were off-CPB (post-CPB)(Time 3). Method of measurement: Pao2/Fio2 measurement kit was used to measure Pao2/Fio2 by atrial blood gas machine. Alveolar–arterial (A-a) gradient. Timepoint: The time points of blood sampling were after induction, before the administration of N-acetylcysteine (NAC) (pre-CPB)(Time 1) as baseline, one hour after CPB (on-CPB)(Time 2) , and one hour after that the patients were off-CPB (post-CPB)(Time 3). Method of measurement: A-a gradient measurement kit was used to measure A-a gradient by atrial blood gas machine. Interleukin-6. Timepoint: The time points of blood sampling were after induction, before the administration of N-acetylcysteine (NAC) (pre-CPB)(Time 1) as baseline, one hour after CPB (on-CPB)(Time 2) , and one hour after that the patients were off-CPB (post-CPB)(Time 3). Method of measurement: Interleukin-6 measurement kit was used to measure Interleukin-6. Shunt. Timepoint: The time points of blood sampling were after induction, before the administration of N-acetylcysteine (NAC) (pre-CPB)(Time 1) as baseline, one hour after CPB (on-CPB)(Time 2) , and one hour after that the patients were off-CPB (post-CPB)(Time 3). Method of measurement: Using the formula used to measure it. Compliance reactive protein (CRP). Timepoint: The time points of blood sampling were after induction, before the administration of N-acetylcysteine (NAC) (pre-CPB)(Time 1) as baseline, one hour after CPB (on-CPB)(Time 2) , and one hour after that the patients were off-CPB (post-CPB)(Time 3). Method of measurement: Compliance reactive protein (CRP) measurement kit was used to measure Compliance reactive protein (CRP). CKMB. Timepoint: The time points of blood sampling were after induction, before the administration of N-acetylcysteine (NAC) (pre-CPB)(Time 1) as baseline, one hour after CPB (on-CPB)(Time 2) , and one hour after that the patients were off-CPB (post-CPB)(Time 3). Method of measurement: Creatine kinase-muscle/brain (CKMB) measurement kit was used to measure creatine kinase-muscle/brain (CKMB). Troponine. Timepoint: The time points of blood sampling were after induction, before the administration of N-acetylcysteine (NAC) (pre-CPB)(Time 1) as baseline, one hour after CPB (on-CPB)(Time 2) , and one hour after that the patients were off-CPB (post-CPB)(Time 3). Method of measurement: Troponine measurement kit was used to measure Troponine. Serum Lactate. Timepoint: The time points of blood sampling were after induction, before the administration of N-acetylcysteine (NAC) (pre-CPB)(Time 1) as baseline, one hour after CPB (on-CPB)(Time 2) , and one hour after that the patients were off-CPB (post-CPB)(Time 3). Method of measurement: Lactate measurement kit was used to measure Lactate. Creatinine. Timepoint: The time points of blood sampling were after induction, before the administration of N-acetylcysteine (NAC) (pre-CPB)(Time 1) as baseline, one hour after CPB (on-CPB)(Time 2) , and one hour after that the patients were off-CPB (post-CPB)(Time 3). Method of measurement: Creatinine measurement kit was used to measure Creatinine. Ejection fraction. Timepoint: The time points of blood sampling were after induction, before the administration of N-acetylcysteine (NAC) (pre-CPB)(Time 1) as baseline, and one hour after that the patients were off-CPB (post-CPB)(Time 3). Method of measurement: Using the formula used to measure it. Zanjan University of Medical Sciences Approved 2013-04-28 Ethics committee of Zanjan University of Medical Sciences Azadi Blvd, Zanjan Zanjan Zanjan Iran (Islamic Republic of)