Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Septic Shock em Steroids

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Unidade de Terapia Intensiva.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Unidade de Terapia Intensiva
ClinicalTrials.gov Identifier:
NCT01047670
First received: January 12, 2010
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Mechanical Ventilation
Mortality
Drug: Hydrocortisone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Reposição de Esteróides em Crianças Com Choque Séptico

Resource links provided by NLM:


Further study details as provided by Unidade de Terapia Intensiva:

Primary Outcome Measures:
  • number of days free of vasoactive support after 7 days of septic shock diagnosis [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: May 2008
Arms Assigned Interventions
Experimental: 1
Hydrocortisone 6 mg/kg/day, 8 hourly, during 7 days or during the vasoactive drug infusion
Drug: Hydrocortisone
Hydrocortisone 6 mg/kg/day, 8 hourly, during 7 days or during the vasoactive drug infusion
Placebo Comparator: 2
placebo
Drug: Hydrocortisone
Hydrocortisone 6 mg/kg/day, 8 hourly, during 7 days or during the vasoactive drug infusion

Detailed Description:

Hypothesis Pediatric patients with septic shock have a high incidence of failure to respond to the ACTH test and would benefit of steroid replacement.

Design Randomized double-blind placebo controlled clinical trail. Outcome Primary: number of days free of vasoactive support after 7 days of septic shock diagnosis.

Methods

Study population:

All children admitted to PICU will be possible enrolled. Inclusion criteria will be (I) age between 1 month and 16 years; (II) septic shock according to the definitions of pediatric 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. Exclusion criteria will be patients with (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.

Stratification criteria:

Patients will be stratified by age, gender, PRISM category, failure to respond to ACTH test, surgical patients, chronic patient, baseline cardiac and oncological disease and presence of ARDS.

Intervention:

Hydrocortisone 6 mg/kg/day, 8 hourly, during 7 days or during the vasoactive drug infusion. The control group will receive placebo.

Randomization:

Randomization will be carried through numbered envelopes, randomized prior to the study beginning, in blocks of 10, ratio 1:1.

Protocol:

Identical vials with hydrocortisone or placebo will be prepared in an industrial pharmacy and labeled using alphabetic letters (A, B, C, D) before the beginning of the study. Each vial of hydrocortisone will have 100 mg of hydrocortisone ponder to be diluted in 10 ml of normal saline 0.9% Each vial of placebo will content a innocuous ponder, also to be diluted in 10 ml of normal saline 0.9%. The drug and its referent letter (A, B, C, D) will be controlled by two lists, handed in by the pharmacist to the researchers inside closed envelopes before the beginning of the study. After enrollment and randomization, children joining the study will have baseline cortisol and ACTH measured. ACTH testes (1 mcg/ 1.75m2 and 250 mcg) will be performed, 4 hours apart. After this, patients will receive the study drug (either hydrocortisone or placebo), 0.2 ml/kg/ dose, 8 hourly. This will last the period the patient requires vasoactive support, or a maximum of 7 days. Daily routine blood results will be noted, as well as a further ACTH test on day 3 if the patient is still on vasoactive support. Demographic data will be collected on enrollment.

  Eligibility

Ages Eligible for Study:   1 Month to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (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. -

Exclusion Criteria:

Exclusion criteria will be patients with

  • (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047670

Contacts
Contact: Pedro Celiny Garcia, phd +55.51.3315.24.00 celiny@terra.com.br
Contact: Carolina Friedrich Amoretti, md +55 51 3339 6474 cfamoretti@hotmail.com

Locations
Brazil
Hospital São Lucas da PUCRS Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Contact: Pedro Celiny Garcia, phd    +55.51.3315.24.00    celiny@terra.com.br   
Contact: Carolina Friedrich Amoretti, md    +55 51 3339 6474    cfamoretti@hotmail.com   
Sponsors and Collaborators
Unidade de Terapia Intensiva
  More Information

No publications provided

Responsible Party: Pedro Celiny Ramos Garcia, Pontifícia Universidade Católica do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT01047670     History of Changes
Other Study ID Numbers: Esteroides725
Study First Received: January 12, 2010
Last Updated: January 12, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Unidade de Terapia Intensiva:
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

Additional relevant MeSH terms:
Cortisol succinate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014