NCT02580240

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

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

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
8 months until next milestone

Results Posted

Study results publicly available

August 7, 2017

Completed
Last Updated

August 7, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

October 18, 2015

Results QC Date

January 24, 2017

Last Update Submit

April 30, 2017

Conditions

Septic Shock

Keywords

septic shockhydrocortisonemortality

Outcome Measures

Primary Outcomes (1)

  • 28-day Mortality

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

    28 days

Secondary Outcomes (1)

  • All Cause Mortality

    90 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: saline

hydrocortisone

EXPERIMENTAL

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).

Drug: Hydrocortisone

Interventions

HydrocortisoneDRUG

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).

Also known as: cortisol
hydrocortisone
salineDRUG

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

Also known as: Normal saline
Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Jiangsu Province people's hospital

Yangzhou, Jiangsu, 225000, China

Location

Related Publications (1)

  • Lv QQ, Gu XH, Chen QH, Yu JQ, Zheng RQ. Early initiation of low-dose hydrocortisone treatment for septic shock in adults: A randomized clinical trial. Am J Emerg Med. 2017 Dec;35(12):1810-1814. doi: 10.1016/j.ajem.2017.06.004. Epub 2017 Jun 5.

    PMID: 28615145DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

HydrocortisoneSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-HydroxycorticosteroidsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
QQLv
Organization
Subei People's Hospital
bonhomie2014@163.com
18051063899

Study Officials

  • Qingquan Lv, Master

    Department of Critical Care Medicine, Northern Jiangsu Province people's hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
Ms Lv

Study Record Dates

First Submitted

October 18, 2015

First Posted

October 20, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

August 7, 2017

Results First Posted

August 7, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)