Melatonin in patients with sepsis

Phase 1

• Conditions: Sepsis; MedDRA version: 20.0Level: PTClassification code 10053879Term: Sepsis syndromeSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-002840-42-GB
• Lead Sponsor: niversity of Aberdeen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-24
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Adult patients (16 y or above) on the ICU at Aberdeen Royal Infirmary with sepsis due to community acquired pneumonia who are within 24h of fulfilling the criteria for sepsis with clinical suspicion of pneumonia and the presence of chest X-ray changes consistent with pneumonia will be recruited. The criteria for sepsis are:

•clinical suspicion or evidence of acute infection
•systemic inflammatory response syndrome, defined by two or more of the following:
1.Core temperature <36 or >38°C;
2.tachycardia: heart rate > 90 beats/min;
3.tachypnoea: respiratory rate > 20 breaths/min or ventilated;
4.leucocyte count >12 x 10^9/L or <4 x 10^9/L.

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

Exclusions:
•<16 years old,
•have a life expectancy <24h,
•have metastatic cancer or immunosuppression,
•are receiving steroids (>20mg/d prednisolone or equivalent, used regularly for >2 weeks prior to ICU admission) or are
•women of child bearing potential without a negative pregnancy test or a history of surgical sterilization.
•patients receiving fluvoxamine or nifedipine,
•those with overt hepatic failure
•those who are unable to understand or comply with the requirements of the trial

Study & Design

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