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IRCT20190126042496N1 IRCT 2019-07-24 Neurofunctional Reseach Center of Shohada Tajrish Hospital Effect of vitamin D in enhanced recovery after brain surgery Acute effect of single high-dose vitamin D3 and the chronic effect of normal levels of 25-OHD on perioperative complications and clinical outcomes in brain tumor surgery patients 2019-04-06 anticipated 60 Complete https://irct.ir/trial/38528 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This study is a Quasi-experimental study in which randomization is not applicable. A group with vitamin D deficiency will receive vitamin D , and there will be no intervention on the group with normal serum levels. The two groups will be compared in terms of post-surgical outcomes, Blinding description: For participants, supplemental vitamin D Injection will be described to enhance and improve the health status and will be included in the study if they are satisfied. However, since this injection will be performed between nurses' routine treatments in patients, the patient will not be aware of the timing of receiving the vitamin and its type. 3 Patients with brain tumors who have candidate for craniotomy surgery. Intervention 1: Intervention group: A group of patients with the serum level of 25OHD ≤ 20 who are known that vitamin D deficiency. The injection of a single dose of vitamin D contains 300,000 units of vitamin D, which will be administered as a single intramuscular injection by a nurse to each patient before surgery. Intervention 2: Control group: patients with normal serum levels of vitamin d (25OHD >30), without any intervention. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Mohammadreza shahmohammadi
Next to Taleghani hospital, Shahid Araabi St., Yaman St.,Shahid Chamran highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 mr_shahmohammadi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mohammadreza shahmohammadi
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
Tehran Iran (Islamic Republic of) 19839-63113 +98 21 2243 9770 mr_shahmohammadi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) The willingness to cooperate and complete the informed consent form by the patient or legal surrogate The patient's age ≥ 18 Definitive diagnosis of brain tumor and need craniotomy for resection Levels of 25-OHD ≤ 20 ng/mL for intervention group Levels of 25-OHD > 30 ng/mL for normal group 18 years no limit Both Unwillingness to co-operate by the patients or their surrogate at the beginning of the study Participation in other clinical trials at the same time with this study Pregnancy and lactation Hypercalcemia Hyperphosphatemia Tuberculosis Sarcoidosis History of nephrolithiasis C71 Malignant neoplasm of brain Treatment - Other Treatment - Other Intervention group: A group of patients with the serum level of 25OHD ≤ 20 who are known that vitamin D deficiency. The injection of a single dose of vitamin D contains 300,000 units of vitamin D, which will be administered as a single intramuscular injection by a nurse to each patient before surgery. Control group: patients with normal serum levels of vitamin d (25OHD >30), without any intervention. Changes in serum levels of 25OHD before and after injection and surgery. Timepoint: Measurement of serum levels of 25OHD at the beginning of the study in all patients. Measurement of serum levels of 25OHD on the fifth day after surgery in intervention group who received a single high dose of vitamin D prior to surgery. Method of measurement: Laboratory measurements of 25OHD serum levels using Monobind kit by Enzyme-Linked Immunosorbent Assay (ELISA) method. Intraoperative Active Bleeding. Timepoint: During surgery time. Method of measurement: Amount of blood loss (cc) during surgery based on estimation of anesthesiologist. Incidence of ventricular fibrillation (VF) during surgery. Timepoint: During surgery time. Method of measurement: Based on doctor's diagnosis. Incidence of cardiac arrest during surgery. Timepoint: During surgery time. Method of measurement: Based on doctor's diagnosis. Incidence of severe bradycardia during surgery. Timepoint: During surgery time. Method of measurement: Based on doctor's diagnosis. Incidence of hypotension during surgery. Timepoint: During surgery time. Method of measurement: Based on doctor's diagnosis. Incidence of hypertension during surgery. Timepoint: During surgery time. Method of measurement: Based on doctor's diagnosis. Incidence of intracranial hematoma after surgery. Timepoint: Immediately after surgery until the end of the hospitalization period for each patient (up to 1 month after surgery). Method of measurement: Based on doctor's diagnosis, computerized tomography (CT) scan, Magnetic resonance imaging (MRI). Incidence of cerebral edema after surgery. Timepoint: Immediately after surgery until the end of the hospitalization period for each patient (up to 1 month after surgery). Method of measurement: Based on doctor's diagnosis, computerized tomography (CT) scan, Magnetic resonance imaging (MRI). Incidence of seizure after surgery. Timepoint: Immediately after surgery until the end of the hospitalization period for each patient (up to 1 month after surgery). Method of measurement: Based on doctor's diagnosis. Incidence of Myocardial Infarction (MI) after surgery. Timepoint: Immediately after surgery until the end of the hospitalization period for each patient (up to 1 month after surgery). Method of measurement: Based on doctor's diagnosis. Incidence of Deep Vain Thrombosis (DVT) after surgery. Timepoint: Immediately after surgery until the end of the hospitalization period for each patient (up to 1 month after surgery). Method of measurement: Based on doctor's diagnosis. Incidence of Pulmonary Embolism (PE) after surgery. Timepoint: Immediately after surgery until the end of the hospitalization period for each patient (up to 1 month after surgery). Method of measurement: Based on doctor's diagnosis. Incidence of meningitis after surgery. Timepoint: Immediately after surgery until the end of the hospitalization period for each patient (up to 1 month after surgery). Method of measurement: Based on doctor's diagnosis. Incidence of postoperative wound infection. Timepoint: Immediately after surgery until the end of the hospitalization period for each patient (up to 1 month after surgery). Method of measurement: Based on doctor's diagnosis. Incidence of Sepsis after surgery. Timepoint: Immediately after surgery until the end of the hospitalization period for each patient (up to 1 month after surgery). Method of measurement: Based on doctor's diagnosis. Length of stay in intensive care unit (ICU). Timepoint: The number of days after surgery from the time of arrival in the ICU until the discharge from there. Method of measurement: Number of days staying in ICU with reference to medical records. Duration of hospitalization. Timepoint: Total number of hospital admission days. Method of measurement: Number of days staying in hospital with reference to medical records. Mortality rate during a month. Timepoint: Immediately after surgery until one month later. Method of measurement: According to the hospital documents as well as the telephone question of the patient or his surrogate. Mortality rate during six months. Timepoint: Immediately after surgery until six months later. Method of measurement: Telephone interview with the patient or his surrogate. Neurofunctional Reseach Center of Shohada Tajrish Hospital Approved 2018-06-17 Institutional Research Ethics Committee - Shahid Beheshti University of Medical Sciences 3rth floor, Faculty of Medicine, next to Taleghani Hospital, Evin, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)