Septic Shock em Steroids

NCT01047670 | Unknown Phase 2 DMC

• 1 other identifier: Esteroides725
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Septic shock is a frequent reason for admission on pediatric intensive care units. Interventions which can change morbidity and mortality of septic shock patients are of great interest. Steroid replacement in adults with severe sepsis and septic shock have been extensively studied. It was recently demonstrated that low dose steroid (\< 300mg/ day) used for more than 5 days was associated with decreased mortality and lower requirement of vasoactive support in the adult population that had a low response to the ACTH test. However, this was not confirmed in the latest results from the CORTICUS study. Use of low dose hydrocortisone, or any other steroid has not been studied in critically ill children. Mortality associated with sepsis in children has decreased in the last decade and currently it is close to 10%, making it difficult to power a study able to show reduced mortality. Taking into account the results from previous studies reporting the high incidence of adrenal failure and its association to worse outcome, we have designed a clinical trial to evaluate the effect of low dose hydrocortisone in children with septic shock: Cortisol Replacement in Children with Sepsis Study.

Conditions

Mechanical Ventilation; Mortality

Keywords

sepsis, shock, adrenal insufficiency, hydrocortisone, children, paediatric intensive care.; number of days free of vasoactive support in 7 days; days free of mechanical ventilation; PICU mortality; mortality among patient with inappropriate response to the ACTH test; baseline cortisol/ PIM2 correlation

Outcome Measures

Primary Outcomes (1)

• number of days free of vasoactive support after 7 days of septic shock diagnosis

Study Arms (2)

1

EXPERIMENTAL

Hydrocortisone 6 mg/kg/day, 8 hourly, during 7 days or during the vasoactive drug infusion

Drug: Hydrocortisone

2

PLACEBO COMPARATOR

placebo

Drug: Hydrocortisone

Interventions

Hydrocortisone DRUG

Hydrocortisone 6 mg/kg/day, 8 hourly, during 7 days or during the vasoactive drug infusion

1; 2

Eligibility Criteria

• Age: 1 Month - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• (I) age between 1 month and 20 years;
• (II) septic shock according to the definitions of paediatric septic shock 2005; -(III) inotrope requirement, as in dopamine \> 5 mcg/kg/mim, dobutamine \> 5 mcg/kg/min or any dose of noradrenaline or adrenaline after adequate fluid resuscitation. -

You may not qualify if:

• (I) baseline disease associated to HPA axis dysfunction;
• (II) steroid use in the past 4 weeks;
• (III) previous use of etomidate; (IV) formal indication for steroids use, and
• (V) formal contraindication to steroid use.

Sponsors & Collaborators

• Unidade de Terapia Intensiva: lead

Study Sites (1)

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

RECRUITING

MeSH Terms

Conditions

Sepsis; Shock; Adrenal Insufficiency

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Central Study Contacts

Pedro Celiny Garcia, phd

CONTACT

+55.51.3315.24.00; celiny@terra.com.br

Carolina Friedrich Amoretti, md

CONTACT

+55 51 3339 6474; cfamoretti@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 13, 2010
• Study Start: May 1, 2008
• Last Updated: January 13, 2010

Record last verified: 2008-03

Locations

BR (1)