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NCT Number: NCT03821714

Effects of Glucocorticoid Combined With Vitamin C and Vitamin B1 on Microcirculation in Severe Septic Shock

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.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Septic shock
  • A dose of norepinephrine (>15ug/min)
  • Age ≥18 and ≤80 years old
  • Signing Informed Consent

Exclusion criteria

  • Meet the inclusion criteria for more than 12 hours
  • Clinician judges that corticosteroid therapy should not be used
  • Pregnant
  • Uncontrolled malignancy
  • Glucocorticoid therapy was used within seven days before admission.
  • Expected death within 24 hours
  • The sublingual microcirculation cannot be measured

Treatment and study plan

Glucocorticoid combination therapy

Drug

Glucocorticoid combination therapy is defined as the combination of hydrocortisone, vitamin C, and vitamin B1.

Other names: Hydrocortisone, vitamin C and vitamin B1

glucocorticoid

Drug

The glucocorticoid group was defined as the use of hydrocortisone alone.

Other names: Hydrocortisone

Primary outcomes

  1. Perfused vessel density (PVD)

    Time frame: 24 hours after treatment

    Determinant of capillary diffusive capacity

Secondary outcomes

  1. proportion of perfusion vessels

    Time frame: 24 hours after treatment

    sublingual microcirculation parameter

  2. total vascular density

    Time frame: 24 hours after treatment

    sublingual microcirculation parameter

  3. microvascular flow index

    Time frame: 24 hours after treatment

    sublingual microcirculation parameter

  4. renal contrast-enhanced ultrasound parameters

    Time frame: 24 hours after treatment

    renal perfusion

  5. lactate

    Time frame: 24 hours after treatment

    Tissue perfusion parameter

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

Effects of Glucocorticoid Combined With Vitamin C and Vitamin B1 Versus Hydrocortisone Alone on Microcirculation in Severe Septic Shock

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 30, 2019
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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