NCT01284452

Brief Summary

Severe sepsis/septic shock is a serious condition associated with high mortality rate. Hydrocortisone has been recommended as a useful treatment to decrease mortality in hemodynamically unstable septic shock patients, not response to fluid and moderate dose of vasopressor. During the progression of severe sepsis/septic shock, multi-organ dysfunction can develop. Acute lung injury (ALI) and its more severe form, acute respiratory syndrome (ARDS) is one of the common organ dysfunction associated with septic shock. Information from a meta-analysis suggested that moderate dose of hydrocortisone may improve the ARDS patients' outcome. Whether hydrocortisone can effectively prevent disease progression and death in severe sepsis/septic shock patients who complicated with ALI/ARDS has not been proven.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 20, 2015

Status Verified

April 1, 2015

Enrollment Period

4 years

First QC Date

January 18, 2011

Last Update Submit

April 17, 2015

Conditions

Septic ShockSevere SepsisAcute Lung InjuryAcute Respiratory Distress Syndrome

Keywords

Septic shockSevere sepsisAcute lung injuryAcute respiratory distress syndromeARDS

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    Death from any cause at 28 days after diagnosis of severe sepsis/septic shock

    28 days

Secondary Outcomes (4)

  • Ventilator free day

    28 day

  • Vasopressor free day

    28 days

  • Rate of renal replacement therapy

    28 days

  • Organ support free days

    28 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Normal saline 50 ml intravenous every 6 hours for 7 days

Drug: Placebo

Hydrocortisone

ACTIVE COMPARATOR

Hydrocortisone 50 mg intravenous every 6 hours for 7 days

Drug: Hydrocortisone

Interventions

PlaceboDRUG

Normal saline 50 ml intravenous every 6 hours for 7 days

Placebo
HydrocortisoneDRUG

Hydrocortisone 50 mg intravenous every 6 hours for 7 days

Hydrocortisone

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years and older
  • Diagnosis of severe sepsis or septic shock according to the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference 1992
  • Diagnosis of acute lung injury or acute respiratory distress syndrome according to the American-European Consensus Conference on ARDS 1994
  • Onset of organ dysfunction within 12 hours before enrollment

You may not qualify if:

  • Indicated for receive corticosteroid
  • Congestive heart failure
  • Contra-indication for hydrocortisone: For example: allergy to hydrocortisone
  • Pregnancy
  • Not agree to sign the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

Related Publications (1)

  • Tongyoo S, Permpikul C, Mongkolpun W, Vattanavanit V, Udompanturak S, Kocak M, Meduri GU. Hydrocortisone treatment in early sepsis-associated acute respiratory distress syndrome: results of a randomized controlled trial. Crit Care. 2016 Oct 15;20(1):329. doi: 10.1186/s13054-016-1511-2.

    PMID: 27741949DERIVED

MeSH Terms

Conditions

Shock, SepticSepsisAcute Lung InjuryRespiratory Distress Syndrome

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockLung InjuryLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Surat Tongyoo, MD

    Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 27, 2011

Study Start

December 1, 2010

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

April 20, 2015

Record last verified: 2015-04

Locations

TH(1)