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Completed

NCT Number: NCT00670254

Hydrocortisone for Prevention of Septic Shock

Severe sepsis is a disease with a high mortality. Development of shock is a most serious complication and increases the risk of death considerably. Application of low dose hydrocortisone is currently recommended only in patients after severe septic shock has been established. Hydrocortisone therapy has a hemodynamic stabilizing effect and may reverse shock, however, the preventive application has not been investigated in a larger study. The study investigates whether low dose hydrocortisone prevents the development of shock in patients with severe sepsis. It is postulated that shock prevention may also affect morbidity and mortality.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitaetsklinikum Aachen, Operative Intensivmedizin Erwachsene, Aachen, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Severe sepsis according to ACCP/CCM criteria
  • Onset of severe sepsis < 48 hours
  • Informed consent
  • Effective contraception in fertile women

Exclusion criteria

  • Septic shock
  • Known hypersensitivity to hydrocortisone and additives
  • Glucocorticoid history which warrants continuation of glucocorticoid administration
  • Other indication for systemic glucocorticoid therapy
  • DNR-order
  • Moribund patient
  • Pregnancy
  • Breast feeding women
  • Age < 18 years
  • Other interventional study
  • Relationship to investigator

Treatment and study plan

Placebo

Drug

Application is identical to experimental arm

Hydrocortisone

Drug

50 mg loading dose, continuous infusion of 200 mg/d for 5 d, 100 mg/d for 2d, 50 mg/d for 2 d, and 25 mg/d for 2 d.

Primary outcomes

  1. Septic shock

    Time frame: 14 days

Secondary outcomes

  1. Mortality

    Time frame: 28, 90, and 180 days; ICU and hospital

  2. Length of stay

    Time frame: ICU and hospital (3-6 months)

  3. Time to death

    Time frame: 28, 90, and 180 days

  4. Time to septic shock

    Time frame: 14 days

  5. Mechanical ventilation

    Time frame: until ICU discharge

  6. Renal replacement therapy

    Time frame: until ICU discharge

  7. Organ dysfunction (SOFA score)

    Time frame: until ICU discharge but day 14 at maximum

  8. Frequency of weaning failure

    Time frame: until ICU discharge

  9. Frequency and severity of muscle weakness

    Time frame: until ICU discharge

  10. Frequency of gastrointestinal bleeding

    Time frame: 28 days

  11. Frequency of secondary infections

    Time frame: 28 days

  12. Delir

    Time frame: ICU discharge

  13. Hypernatremia

    Time frame: 14 days

  14. Hyperglycemia

    Time frame: 14 days

  15. Other adverse events

    Time frame: 28 days

  16. Posttraumatic stress disorder / health-related quality of life

    Time frame: Hosptal discharge and 180 days after hospital discharge

  17. Immune response to hydrocortisone

    Time frame: 6 days

  18. Adrenal function

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Coordination Centre for Clinical Trials Leipzig
  • German Federal Ministry of Education and Research
  • SepNet - Critical Care Trials Group

Registry information

Official study title

Placebo-controlled, Randomised, Double-blind Study to Investigate the Efficacy and Safety of Low Dose Hydrocortisone to Prevent the Development of Septic Shock in Patients With Severe Sepsis

Acronym: HYPRESS

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
May 1, 2008
Registry last updated
Sep 27, 2013

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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