Melatonin for Renal Protection in Patients Receiving Polymyxin B

• Status: Terminated
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study has the objective to evaluate the effect in renal function of 30mg of Melatonin versus placebo in patients ≥18 years old treated with polymyxin B. The development of nephrotoxicity will be evaluated by RIFLE(Risk, Injury, Failure, Loss, End stage renal disease) score and KIM-1 urinary biomarker for the first 14 days of polymyxin B therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; Pontificia Universidade Católica do Rio Grande do Sul
• Treatments: Melatonin; Polymyxin B; Polymyxins

Criteria

Inclusion Criteria:

1. Treatment with polymyxin B ( a second inclusion will be accepted if the end of the previous treatment was more than 30-days before enrollment)

2. Agreement with the consent form

Exclusion Criteria:

1. Suspension of polymyxin B therapy with <48hs

2. Death in <48hs

3. Dialysis or Glomerular Filtration Rate (GFR) <10 ml/min at the beginning of treatment by the Modification in Diet in Renal Disease (MDRD) formula

4. Lactose intolerance

5. ICU admission at the beginning of therapy

6. Previous regular use of Melatonin

7. Pregnancy

8. Patients deprived from liberty

9. Unability to receive oral medication (i.e total parenteral nutrition)