Dose assessment of melatonin in sepsis trial

Phase 1

Completed

• Conditions: Sepsis due to community acquired pneumonia; Infections and Infestations; Sepsis

• Registration Number: ISRCTN70688534
• Lead Sponsor: niversity of Aberdeen/NHS Grampian (UK)

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36046952/ (added 20/09/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-29
• Study Completion: 2022-02-28
• Last Update Posted: 10 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Patients who are within 24h of fulfilling the criteria for sepsis with clinical suspicion of community acquired 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 plus 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

Exclusion Criteria

1. Anyone <16 years old
2. Life expectancy <24h
3. Metastatic cancer or immunosuppression
4. Taking steroids (>20mg/d prednisolone or equivalent, used regularly for >2 weeks prior to ICU admission)
5. Premenopausal females without a negative pregnancy test or a history of surgical sterilization.
6. Patients receiving fluvoxamine or nifedipine
7. Consent refusal

Study & Design

• Study Type: Interventional
• Study Design: Not specified