A clinical trial of melatonin for the study of abdominal surgery patients with sepsis may develop multiorgan failure.

• Conditions: Septic patients of abdominal surgery; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2008-006782-83-ES
• Lead Sponsor: Hospital Universitario Virgen de las Nieves

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-16
• Last Update Posted: 7 October 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients who are in clinical status from severe sepsis according to the diagnostic criteria
American College of Chest Physicians / Society of Critical Care Medicine (Annex I), ie
patients with systemic inflammatory response syndrome associated to infectious etiology dysfunction
organic, hypoperfusion or hypotension, and will undergo surgery.
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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Age under 18 years, pregnancy, medical or surgical terminal disease, hepatic or
chronic renal disease, psychiatric treatment or refusal to participate in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified