NCT06206759 Vitamin C Administration and Triglycerides Level in Critical Care Patients
| NCT ID | NCT06206759 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Meir Medical Center |
| Condition | Hypertriglyceridemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2024-05-01 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Vitamin C (ascorbic acid) is a water-soluble vitamin with antioxidant properties. Previous studies showed that the administration of vitamin C was associated with decreased triglyceride (TG) levels in ambulatory patients, especially in patients with type 2 diabetes. The decrease in TG level was more significant the younger the patient's age (less than 52.8 years), the longer the administration of vitamin C lasted (over 12 weeks) and the higher the daily dose was (over 1 gram per day) (2). However, we did not find any studies that examined the relationship between administration of vitamin C and lowering of TG level in critical patients in intensive care. High TG levels are often found in these patients, secondary to sepsis, administration of propofol by continuous infusion, administration of TPN, pancreatitis, liver failure and chronic dyslipidemia, diabetes and chronic renal failure. High TG levels in these patients may cause pancreatitis secondary to elevated TG, and we take several actions to lower TG levels in the unit when they exceed 500 mg per dL in order to avoid these complications. The actions taken include starting treatment with fibrates and/or statins, giving high-dose insulin, stopping the propofol drip and changing it to another hypnotic drug (usually midazolam), and giving fat-free TPN instead of fat-containing TPN. There are of course disadvantages to these interventions, such as drug interactions, longer clearance time and higher incidence of delirium when giving midazolam compared to propofol, hypoglycemia when giving a continuous insulin drip in high doses and giving a lower amount of calories to a patient who will receive TPN without lipids. There are many studies that examined the administration of vitamin C to patients in intensive care, especially patients with sepsis, with varied but inconclusive results. A recently published meta-analysis found a reduction in mortality among critical intensive care patients treated with intravenous vitamin C, especially in the subgroup of critically ill patients with a high risk of in-hospital mortality. The drug was found to be safe for use among patients in intensive care. In these patients in the various studies, vitamin C treatment was given intravenously in different doses, with most patients receiving a dose of 6 grams per day for 3-5 days. In light of a trend about five years ago that showed an improvement in survival among septic patients in intensive care who were treated with intravenous vitamin C as monotherapy, or in combination with steroids and/or intravenous thiamine, also in the intensive care unit at our institution (as well as in other hospitals) we started giving this treatment, at the recommended dose of 6 grams per day for 3-5 days. Over time, new studies did not find clear benefits for this treatment, so we gradually stopped giving it. However, if indeed vitamin C can contribute to a significant decrease in TG levels in patients in intensive care, there may be a point in administering it to a group of patients with high TG levels, in order to reduce complications associated with a high TG level and/or treatment to reduce it.
Eligibility Criteria
Inclusion Criteria: patients aged 18-99 who were admitted to the general intensive care unit from January 2017 to December 2023, and who were treated with intravenous vitamin C. The control group will include patients with the same characteristics who were not treated with vitamin C. Exclusion criteria: patients who did not meet the above conditions or for whom data were missing. \- \-
Frequently Asked Questions
Who can join the NCT06206759 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Hypertriglyceridemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06206759 currently recruiting?
Yes, NCT06206759 is actively recruiting participants. Visit ClinicalTrials.gov or contact Meir Medical Center to inquire about joining.
Where is the NCT06206759 trial being conducted?
This trial is being conducted at Kfar Saba, Israel.
Who is sponsoring the NCT06206759 clinical trial?
NCT06206759 is sponsored by Meir Medical Center. The trial plans to enroll 2,000 participants.