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This study intends to observe the effect of intravenous hydrocortisone combined with vitamin C and vitamin B1 infusion on the prognosis and sublingual microcirculation in patients with sepsis or septic shock through a prospective randomized controlled study method.
Shock is a common pathophysiological state in critical care medicine and occupies an important position. In recent years, some studies have had uesd metabolic resuscitation agent -- namely hydrocortisone + vitamin C + vitamin B1 cocktail therapy in the treatment of sepsis patients, studies found that this method may reduce the lactate level, improve renal failure and circulatory failure, and then improve the prognosis of such patients. There are also study groups that do not significantly prolong the survival of septic shock, suggesting that we need to screen out the use of metabolic resuscitation agents. Given the important role of vitamins in shock, uncontrolled inflammatory response, capillary leakage, and microcirculation dysfunction, whether the improved prognosis may be related to the patients' own vitamin levels. Vitamin deficiency is often present in the elderly.
This study aims to observe the effect of precision treatment of metabolic resuscitation agent on mortality and sublingual microcirculation in the follow-up prognosis of elderly septic patients on the basis of monitoring vitamin B1 and C levels in elderly septic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metabolic resuscitation agents | Experimental | Patients in the intervention group received IV hydrocortisone (200mg every 24 hours), vitamin C (1.5g every 6 hours), and thiamine (200 mg every 12 hours). |
|
| hydrocortisone | Placebo Comparator | Patients in the control group received IV hydrocortisone (200mg every 24 hours). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metabolic resuscitation agent | Drug | Intervention group will receive intravenous hydrocortisone (200mg every 24 hours), vitamin C (1.5g every 6 hours), and thiamine (200 mg every 12 hours). |
| Measure | Description | Time Frame |
|---|---|---|
| 28-d Mortality | patients with sepsis who died after treatment from any cause within 28 days | 28 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Perfused vessel density (PVD) | Determinant of capillary diffusive capacity | 48 hours after treatment |
| proportion of perfusion vessels | sublingual microcirculation parameter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingyuan Xu, M.D. | Contact | 8602583262550 | xujingyuanmail@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jingyuan Xu, M.D. | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| D001205 | Ascorbic Acid |
| D013831 | Thiamine |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| Hydrocortisone | Drug | Placebo group will receive intravenous hydrocortisone 200mg every 24 hours. |
|
| 48 hours after treatment |
| Lactate clearance, 48h, % | Tissue perfusion parameter | 48 hours after treatment |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |