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IRCT20120216009045N5 IRCT 2023-02-19 Tehran University of Medical Sciences The effect of vitamin C in shock Effect of vitamin C on inflammatory profile and circulatory shock in colon cancer patients undergoing colectomy in Imam Khomeini Hospital in Tehran 2023 2022-12-22 anticipated 42 Complete https://irct.ir/trial/68528 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The simple randomization method is in the form of a letter. In this method, a number of cards or letters chosen by the researcher are considered as the first group and the same number of cards for the next groups it is possible. By merging the cards together, one card is issued and its allocation is recorded, and that card is returned to the group of other cards after being issued. The cards are merged again and another card is removed. This process continues until reaching a random sequence according to the sample size. Stratified randomization is used in studies with small sample size. Based on simple randomization, they are able to produce random sequence by block method, including "Random software allocation" software. The method of concealment of random allocation is the use of sealed and waxed opaque envelopes in a random sequence. According to the sample size of the research is a number of envelopes with aluminum foil (due to the lack of clarity of the content envelopes), preparation and each of the created random sequences is recorded on a card and the cards are placed in the letter envelopes in order. In order to preserve the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box in order. At the time of the registration of the participants, according to the order of entry of the eligible participants into the study, one of the letter envelopes was opened in order and its assigned group was found. The participant is revealed, Blinding description: This study is a double-blind type, which means that both the study participants and the patient outcome assessor will not know about the type of interventions. The intervention under study and the placebo will be completely similar in terms of color, size and smell. Except for the main researcher of the study, who has the role of the project leader and has no role in selecting patients, choosing interventions, prescribing interventions, evaluating the outcome of patients, he will know the type of interventions assigned to patients, finally none of the participants and evaluating researchers. Outcome Patients will not know the type of interventions received until the end of the study. The data analyst also does not know the type of intervention and control groups. 3 Hemodynamic Shock. Intervention 1: Intervention group: Vitamin C (Elixir, Iran)1.5 g every 6 hours in 0.9% normal saline (Qazi, Iran) was added to a volume of 50 ml through a syringe pump within 30 minutes. It is injected into peripheral or central vessels. This prescription is given for 5 days. Intervention 2: Control group: Normal saline 0.9% (Qazi, Iran) is reached to a volume of 50 ml and is injected into peripheral or central vessels through a syringe pump in a period of 30 minutes. This prescription is given for 5 days. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identification of subjects and termination of the study. When: Access starts one year after the end of the study and publication of the results To whom: Researchers working in academic and scientific institutions Conditions: They will be allowed to use the documents to carry out research projects without changing the data analysis. Where to obtain: Imam Khomeini Hospital Complex, Dr. Gharib Ave, Keshavarz Blvd., Tehran. Postal code: 1419733141 Dr. Mohammad Taghi Beig Mohammadi Contact number :0098911759016 Email address: mbage46@gmail.com How to obtain: Face-to-face communication, phone calls, and email addresses are available and will be answered as soon as possible if eligible. Comments:
public Mohammad Taghi Beig Mohammadi
Imam Khomeini Hospital Complex, Dr. Gharib Ave., Keshavarz Blvd.
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6119 0000 mbage46@gmail.com Tehran University of Medical Sciences scientific Mohammad Taghi Beig Mohmmadi
Imam Khomeini Hospital Complex, Dr. Gharib Ave., Keshavarz blvd.
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6119 0000 mbage46@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients over 20 years old Undergoing elective colon cancer surgery for the first time Following the postoperative shock, they are immediately admitted to the ICU 20 years no limit Both Sepsis before surgery Myocardial ischemia in a recent hospitalization (positive troponin test on two time) Acute kidney injury (creatinine increase 1.5 times the baseline creatinine level) Immunotherapy before surgery oxalate kidney stones G6PD enzyme deficiency History of rheumatic disease History of corticosteroid use History of rheumatic disease Morbid obesity (BMI ≥40) Simultaneous cancers in other organs metastatic cancer Previous colon cancer surgery R57.9 Shock, unspecified Treatment - Drugs Placebo Intervention group: Vitamin C (Elixir, Iran)1.5 g every 6 hours in 0.9% normal saline (Qazi, Iran) was added to a volume of 50 ml through a syringe pump within 30 minutes. It is injected into peripheral or central vessels. This prescription is given for 5 days. Control group: Normal saline 0.9% (Qazi, Iran) is reached to a volume of 50 ml and is injected into peripheral or central vessels through a syringe pump in a period of 30 minutes. This prescription is given for 5 days. Inflammatory factors ( IL-6, CRP, Lactate, ESR). Timepoint: At the beginning of the study and then daily for 5 days. Method of measurement: Laboratory examination of blood samples. Length of hospitalization. Timepoint: From the beginning of the study until discharge or death. Method of measurement: Daily checking of the variables by the researcher. Duration of hospitalization in the intensive care unit. Timepoint: From the beginning of the study on a daily basis until discharge or death from the intensive care unit. Method of measurement: Number of days assessed by the researcher. Tehran University of Medical Sciences Approved 2023-01-08 Ethics committee of Tehran University of Medical Sciences Imam Khomeini Hospital Complex, Dr. Gharib Ave., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)