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Clinical Trials/EUCTR2009-017825-21-ES
EUCTR2009-017825-21-ES
Active, not recruiting
Not Applicable

Prospective, randomised, double-blind study to evaluate the efficacy of treatment with melatonin in adult patients with severe sepsis or septic shock.

INSTITUTO ARAGONÉS DE CIENCIAS DE LA SALUD0 sites110 target enrollmentApril 16, 2010
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ConditionsSevere sepsis or septic shock.MedDRA version: 14.0Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Severe sepsis or septic shock.
Sponsor
INSTITUTO ARAGONÉS DE CIENCIAS DE LA SALUD
Enrollment
110
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 16, 2010
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
INSTITUTO ARAGONÉS DE CIENCIAS DE LA SALUD

Eligibility Criteria

Inclusion Criteria

  • •a) Patient admitted to the Intensive Care Unit (ICU),
  • •b) Aged 18 years or over.
  • •c) Fulfils the diagnostic criteria of severe sepsis or septic shock secondary to extrahospital or intrahospital pneumonia and/or intraabdominal infection.
  • •d) More than 24 hours has passed after recording the first organ dysfunction.
  • •e) To be receiving the standard treatments for these conditions according to universally accepted guidelines\* (Dellinger RP et al, 2008\) and with the antibiotherapy protocol of our ICU.
  • •f) Signed informed consent.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 55

Exclusion Criteria

  • •a) Absence of informed consent.
  • •b) Patient identified as being very close to death.
  • •c) Patient expected to die within 28 days from a medical condition that cannot be cured, such as a poorly controlled neoplasm or other terminal illness.
  • •d) History of organ transplant.
  • •e) Absence of concomitant intensive treatment.

Outcomes

Primary Outcomes

Not specified

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