MedTrace Logo

Melatonin for Renal Protection in Patients Receiving Polymyxin B

NCT03725267 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2021-08-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Melatonin Pill

Patients will receive 1 pill of melatonin each day during polymyxin B therapy for a maximum of 14 days.

DRUG

Placebo oral capsule

Patients will receive 1 pill of placebo each day during polymyxin B therapy for a maximum of 14 days.

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Pontificia Universidade Católica do Rio Grande do Sul

    collaborator OTHER

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Maria Helena P Rigatto, Professor · Hospital de Clínicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2021-06-15
Completion
2021-07-01

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03725267 on ClinicalTrials.gov