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Completed

NCT Number: NCT02580240

Initiation of Hydrocortisone for the Treatment of Septic Shock

The purpose of this study : 1）to determine whether hydrocortisone is effective in the treatment of septic shock and 2) to identify the role of timing of low dose hydrocortisone administration 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northern Jiangsu Province people's hospital

Yangzhou, Jiangsu, 225000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age 18 years old or older;
  • onset of septic shock within 6 h

Exclusion criteria

  • Systemic corticosteroid therapy within the last 3 months before septic shock;
  • high-dose steroid therapy;
  • immunosuppression;
  • refusal of the attending staff or patient family.

Treatment and study plan

Hydrocortisone

Drug

Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).

Other names: cortisol

Saline

Drug

Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.

Other names: Normal saline

Primary outcomes

  1. 28-day Mortality

    Time frame: 28 days

    Death from any cause at 28 days after the onset of septic shock

Secondary outcomes

  1. All Cause Mortality

    Time frame: 90 days

    Death from any cause at 90 days after the onset of septic shock

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Official study title

Early Initiation of Low-dose Hydrocortisone Treatment for Septic Shock in Adults: a Randomized Clinical Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 20, 2015
Registry last updated
Aug 7, 2017

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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