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IRCT201607232083N7 IRCT 2017-04-28 Management and technology assistance of Mashhad university of medical sciences, school of pharmac Study the effect of Granulocyte colony stimulating factor (G-CSF) influence on neurological and cardiac toxicity caused by carbon monoxide in patients with carbon monoxide poisoning Study the effect of Granulocyte colony stimulating factor (G-CSF) influence on neurological and cardiac toxicity caused by carbon monoxide in patients with carbon monoxide poisoning in two groups drug and placebo 2016-11-21 anticipated 40 Complete https://irct.ir/trial/1698 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 1 Carbon monoxide poisoning. Intervention 1: Granulocyte colony-stimulating factor (G-CSF) at dose 180 μg / Kg, one-third of the total dose as a loading dose within 20 minutes and the remaining two-thirds dose for continuous infusion at a constant rate during the 72 hours prescribed to patients. Intervention 2: 100 ml of sodium chloride isotonic injection of a third of the total dose as the dose loading within 20 minutes, and two-thirds of the remaining dose for continuous infusion at a constant rate over 72 hours administrated in carbon monoxide poisoned patients.
public Dr. Seyed Reza Mousavi
Ibn Sina street, Imam Reza square
Mashhad Iran (Islamic Republic of) +98 518598973 MousaviR@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Amir Houshang Mohammadpour
Azadi Square campus of Ferdowsi university school of pharmacy
Mashhad Iran (Islamic Republic of) +98 51 3882 3255 MohamadpoorAH@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: diagnosis of carbon monoxide poisoning based on clinical and laboratory findings; poisoning severity of moderate to severe based on the concentration of carboxyhemoglobin and clinical symptoms (NIHSS); poisoned patients must be enrolled within 24 hours of incidence of toxicity; Age between 18 and 70 years Exclusion criteria: Pregnancy; Other Simultaneous poisoning; Burn; the history of neurosurgical and head trauma During the past 4 weeks; multiple trauma 6 - ischemic stroke or hemorrhagic during the last 4 weeks; Malignancies; chronic inflammatory diseases; hematologic malignancies; allergies and or elevated titers of antibodies against erythropoietin and high blood pressure180/110; cardiovascular disease; any previous cerebrovascular lesions 14 years 70 years Both T58 Toxic effect of carbon monoxide Treatment - Drugs Placebo Granulocyte colony-stimulating factor (G-CSF) at dose 180 μg / Kg, one-third of the total dose as a loading dose within 20 minutes and the remaining two-thirds dose for continuous infusion at a constant rate during the 72 hours prescribed to patients 100 ml of sodium chloride isotonic injection of a third of the total dose as the dose loading within 20 minutes, and two-thirds of the remaining dose for continuous infusion at a constant rate over 72 hours administrated in carbon monoxide poisoned patients. S100B serum concentration. Timepoint: Day 1 pre-intervention, 3 and 30 after intervention. Method of measurement: Elysa kit. NIHSS. Timepoint: Day 1 pre-intervention, 3 and 30 after intervention. Method of measurement: NIHSS scor chart. Barthel Index. Timepoint: Day 30 after intervention. Method of measurement: Barthel Index chart. TI serum concentration. Timepoint: In 3,12, 24, 48 and 72 houers after intervention. Method of measurement: Elysa kit. Cardiac arrhythmias. Timepoint: During 24 h after intervention. Method of measurement: ECG holter monitor. G-CSF serum concentration. Timepoint: in times 0.5, 1, 2, 5, 8, 12, 24, 48 h after intervention. Method of measurement: elysa kit. Vital signs: BP, HR, T and RR. Timepoint: Every 4 hours during the first 24 hours, every 6 hours during the second and third days. Method of measurement: By nurse. Modified Rankin score. Timepoint: In day 30 after intervention. Method of measurement: Modified Rankin score chart. Carboxyhemoglobin serum concentration. Timepoint: In Day1 (pre-intervention), 3 and 30 after intervention. Method of measurement: GC-mas-mas Headspace. Glial Fibrilary Acidic protein(GFAP) serum concentration. Timepoint: Day1 (pre-intervention), 3 and 30 after intervention. Method of measurement: Elysa kit. Myeloperoxidase serum concentration. Timepoint: Day1 (pre-intervention), 3 and 30 after intervention. Method of measurement: Elysa kit. Myelin basic protein. Timepoint: Day1 (pre-intervention), 3 and 30 after intervention. Method of measurement: Elysa kit. Cerebral ischemia. Timepoint: Day1 (pre-intervention), 3 and 30 after intervention. Method of measurement: Brain MRI. Headache, asthenia, memory impairment, sleep disorders, trouble concentrating, visual disturbances and behavioral disorders. Timepoint: Day1 (pre-intervention), 3 and 30 after intervention. Method of measurement: By specialist. Management and technology assistance of Mashhad university of medical sciences, school of pharmac Approved 2016-11-13 ٍEthics committee of Mashhad University of Medical Sciences Azadi Square, Ferdowsi University campus Mashhad Iran (Islamic Republic of)