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Completed

NCT Number: NCT02114710

Effects of Stress Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock

The purpose of this study is to find out whether stress doses of hydrocortisone attenuate coagulation dysfunction in patients with septic shock. And discuss the probable mechanism by which little doses of hydrocortisone influence coagulation system in sepsis.

Completed

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Key information

Conditions

Coagulation Dysfunction in Septic Shock Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemodynamic Improvement Induced by Hydrocortisone Hemorrhagic Disorders Hemostatic Disorders Vascular Diseases

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

Patients were randomized to receive either low-dose hydrocortisone or matching placebo.Severity of coagulopathy was estimated using ISTH DIC score. We determined the complications and mortality in two groups, and analyzed the relationship between hydrocortisone and coagulopathy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients(age≧18y)
  • Admitted for septic shock were considered eligible if they had no life-threatening systemic disease (ASA groups 1~3)

Exclusion criteria

  • Lactation
  • Mental disorders
  • Disseminated cancer
  • Secondary cancers
  • Inflammatory bowel disease, or diseases hindering epidural analgesia

Treatment and study plan

Hydrocortisone

Drug

Hydrocortisone hemisuccinate (Roussel-Uclaf, Romainville, France), 50 mg intravenously every 6 hrs

Primary outcomes

  1. death

    Time frame: 30 days after inclusion

Secondary outcomes

  1. clinical perioperative complications

    Time frame: 30 days after inclusion

  2. clinical complications

    Time frame: 30 days after inclusion

    MODS SOFA score

Sponsors and collaborators

Lead sponsor

Nanjing PLA General Hospital

Other

Registry information

Official study title

Study of Little Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 15, 2014
Registry last updated
Apr 15, 2014

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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