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This study aimed to investigate the effect of Glucocorticoid combined with vitamin C and vitamin B1 versus hydrocortisone alone on microcirculation in septic shock patients.
This prospective, double-blind, randomized, controlled trial enrolled septic shock patients admitted to the intensive care unite of a tertiary teaching hospital. We randomly assigned the enrolled patients to the treatment group (hydrocortisone combined with vitamin C and vitamin B1 added to standard care) and the control group (hydrocortisone alone added to standard care) in a 1:1 ratio. The primary outcome was perfusion vascular density (PVD) at 24 hours after treatment. We used the sublingual microcirculation imaging system to monitor PVD. We further validated the primary outcome by observing differences in renal perfusion monitored by renal contrast-enhanced ultrasound (CEUS) between the treatment group and the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucocorticoid combination therapy Group | Experimental | Hydrocortisone 200mg continuous intravenous infusion(24h) combined with vitamin C1.5g intravenous infusion every 6 hours and vitamin B1 200mg intravenous infusion every 12 hours. |
|
| Glucocorticoid Group | Active Comparator | Hydrocortisone 200mg continuous intravenous infusion(24h) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucocorticoid combination therapy | Drug | Glucocorticoid combination therapy is defined as the combination of hydrocortisone, vitamin C, and vitamin B1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perfused vessel density (PVD) | Determinant of capillary diffusive capacity | 24 hours after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of perfusion vessels | sublingual microcirculation parameter | 24 hours after treatment |
| total vascular density | sublingual microcirculation parameter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jingyuan Xu, PhD | Southeast University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Zhongda Hospital, Southeast University | Nanjing | Jiangsu | 210000 | China |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| D001205 | Ascorbic Acid |
| D013831 | Thiamine |
| D005938 | Glucocorticoids |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| Glucocorticoid | Drug | The glucocorticoid group was defined as the use of hydrocortisone alone. |
|
|
| 24 hours after treatment |
| microvascular flow index | sublingual microcirculation parameter | 24 hours after treatment |
| renal contrast-enhanced ultrasound parameters | renal perfusion | 24 hours after treatment |
| lactate | Tissue perfusion parameter | 24 hours after treatment |
| D010335 |
| Pathologic Processes |
| 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 |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |