NCT00320099

Brief Summary

This study will compare, in adults with septic shock, the safety and efficacy of a combination of moderate doses of corticosteroids and intensive insulin therapy to that of moderate doses of corticosteroids. In addition, this study will compare the efficacy and safety of hydrocortisone alone versus hydrocortisone plus fludrocortisone

Trial Health

87
On Track

Trial Health Score

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

Enrollment
508

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2006

Typical duration for phase_3

Geographic Reach
1 country

8 active sites

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

January 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2006

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

April 6, 2010

Status Verified

April 1, 2010

Enrollment Period

3 years

First QC Date

April 27, 2006

Last Update Submit

April 5, 2010

Conditions

Septic Shock

Keywords

septic shockadrenal insufficiencyglucose controlmineralocorticoids

Outcome Measures

Primary Outcomes (1)

  • In-hospital mortality

    Day 180

Secondary Outcomes (8)

  • Secondary outcomes :

    Day 180

  • 90-day and 180-day mortality.

    Day 180

  • Duration of life-supporting treatments (i.e. vasopressors and mechanical ventilation)

    Day 180

  • Time to resolve multiple organ dysfunction, i.e. to obtain a SOFA score < 8

    Day 180

  • Hospital length of stay.

    Day 180

  • +3 more secondary outcomes

Study Arms (4)

1

ACTIVE COMPARATOR

Hydrocortisone and convention glycemic control

Drug: hydrocortisone

2

EXPERIMENTAL

Hydrocortisone and fludrocortisone and conventional glucose control

Drug: hydrocortisoneDrug: fludrocortisone

3

EXPERIMENTAL

Hydrocortisone and intensive insulin therapy

Drug: recombinant human insulinDrug: hydrocortisone

4

EXPERIMENTAL

hydrocortisone, fludrocortisone and intensive insulin therapy

Drug: recombinant human insulinDrug: hydrocortisoneDrug: fludrocortisone

Interventions

recombinant human insulinDRUG

intensive insulin therapy as a continuous infusion to maintain blood glucose levels between 4 and 6 mmol/l

34
HydrocortisoneDRUG

50 mg as iv bolus every 6 hours for 7 days

1234
fludrocortisoneDRUG

50 µg once a day via a nasogastric tube for seven days

24

Eligibility Criteria

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

You may qualify if:

  • Patients admitted in intensive care units for septic shock and meeting all following criteria
  • Proven infection
  • Need for vasopressor to maintain systemic arterial tension above 90 mmHg
  • Multiple organ dysfunction as defined by a SOFA score ³ 8.
  • Need for treatment with moderate dose of corticosteroids

You may not qualify if:

  • One of the following :
  • Pregnancy
  • Less than 18 years old
  • Moribund (i.e. expected to die on day of intensive care unit admission)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hôpital Avicenne

Bobigny, France

Location

Hôpital Jean Verdier

Bondy, France

Location

CHU Grenoble

Grenoble, France

Location

Hôpital central

Nancy, France

Location

Hôpital Saint Louis

Paris, 75, France

Location

Hôpital Bichat Claude Bernard

Paris, France

Location

hôpital Cochin

Paris, France

Location

Hôpital Delafontaine

Saint-Denis, 93, France

Location

Related Publications (1)

  • COIITSS Study Investigators; Annane D, Cariou A, Maxime V, Azoulay E, D'honneur G, Timsit JF, Cohen Y, Wolf M, Fartoukh M, Adrie C, Santre C, Bollaert PE, Mathonet A, Amathieu R, Tabah A, Clec'h C, Mayaux J, Lejeune J, Chevret S. Corticosteroid treatment and intensive insulin therapy for septic shock in adults: a randomized controlled trial. JAMA. 2010 Jan 27;303(4):341-8. doi: 10.1001/jama.2010.2.

    PMID: 20103758RESULT

MeSH Terms

Conditions

Shock, SepticAdrenal Insufficiency

Interventions

HydrocortisoneFludrocortisone

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockAdrenal Gland DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Djillali annane, MD, PhD

    Assistance Publique Hôpitaux de Paris - University of Versailles

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2006

First Posted

May 3, 2006

Study Start

January 1, 2006

Primary Completion

January 1, 2009

Study Completion

February 1, 2009

Last Updated

April 6, 2010

Record last verified: 2010-04

Locations

FR(8)