Effect of vitamin C on inflammatory profile and circulatory shock in colon cancer patients undergoing colectomy in Imam Khomeini Hospital in Tehran 2023

Determining the effect of vitamin C on inflammatory profiles and circulatory shock in colon cancer patients undergoing colectomy

Clinical trial with two parallel group randomized, double-blind, design on 42 patients, "Random software allocation" software was used for randomization.

Study related to patients with colon cancer, for elective laparotomy colectomy in Imam Khomeini hospital complex in Tehran. It is a double-blind type, where the participants and the outcome assessor are unaware. In the intervention group, receive vitamin C and their inflammatory factors are measured compared to control group.

Inclusion criteria include patients over 20 years of age undergoing elective colon cancer surgery for the first time, who are admitted to the intensive care unit with post-operative shock. Exclusion criteria: sepsis before surgery, myocardial ischemia in recent hospitalization (positive troponin test on two times), acute kidney injury (creatinine increase 1.5 times the baseline creatinine level), immunotherapy before surgery, oxalate kidney stones (urinalysis), G6PD enzyme deficiency, immunotherapy before surgery, history of corticosteroid use, rheumatic disease, morbid obesity (BMI≥40), concurrent cancers in other organs or having cancer with metastasis and previous colon cancer surgery.

In the intervention group, vitamin C (Elixir, Iran) in 0.9% normal saline (Qazi, Iran) with a dose of 6 grams per day (1.5 g every 6 hours) was added to a volume of 50 ml through a syringe pump during injected to peripheral or central vessels in 30 minutes. It is prescribed for 5 days. Patients in the control group were given a placebo (0.9% normal saline) at the same time and number of times.

Function of organs and inflammatory factors

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.

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.

All data can be shared after de-identification of subjects and termination of the study.

Access starts one year after the end of the study and publication of the results

Researchers working in academic and scientific institutions

They will be allowed to use the documents to carry out research projects without changing the data analysis.

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

Face-to-face communication, phone calls, and email addresses are available and will be answered as soon as possible if eligible.