Activated Protein C and Corticosteroids for Human Septic Shock

Summary

This study aims at comparing the efficacy and safety of recombinant human activated protein C to that of low dose of corticosteroids and at investigating the interaction between these drugs in the management of septic shock

Conditions

• Septic Shock

Interventions

DRUG

placebos

placebo of hydrocortisone as an iv bolus every 6 hours for seven days plus placebo of fludrocortisone given through the nasogastric tube once a day for seven days plus placebo of activated protein C given as a continuous infusion for 96 hours

DRUG

hydrocortisone and fludrocortisone and placebo

hydrocortisone will be given as 50mg iv bolus every 6 hours for seven days and a tablet of 50µg of fludrocortisone will be given once a day via the nasogastric tube for seven days and a placebo of activated protein C will be given as a continuous infusion for 96 hours

DRUG

recombinant human activated protein C and placebos

activated protein C will be given as a continuous infusion at a dose of 24 µg/kg/h four 96 hours and hydrocortisone placebo as an iv bolus every 6 hours and fludrocortisone placebo once a day through the gastric tube will be given for seven days

DRUG

recombinant human activated protein C and hydrocortisone and fludrocortisone

96 hours continuous infusion of 24µg/kg/h of activated protein C plus seven day treatment with 50mg iv bolus of hydrocortisone every 6 hours and 50µg of fludrocortisone via the nasogastric tube once a day

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris

  collaborator OTHER

• Ministry of Health, France

  collaborator OTHER_GOV

• University of Versailles

  lead OTHER

Principal Investigators

• Benoit Misset, MD · Unity Health Toronto

• Claude Martin, MD · Assistance Publique Hopitaux de Marseille, hôpital Nord

• Alain Cariou, MD · Assistance Publique Hôpitaux de Paris, Hôpital Cochin

• Jean Carlet, MD · Unity Health Toronto

• Christian Brun Buisson, MD · Assistance Publique Hôpitaux de Paris, Hôpital Henri Mondor

• Djillali Annane, MD · Assistance Publique Hôpitaux de Paris, Hôpital Raymond Poincaré

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-03-31

Primary Completion

2015-06-30

Completion

2016-07-31

Countries

• France

Study Locations