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Prevention of Acute Kidney Injury by N-Acetylcystein in Patients Undergone Cardiac Valve Replacement

NCT03440268 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2018-03-05

No results posted yet for this study

Summary

This is a randomized clinical trial, double-blind, placebo-controlled study with the goal to assess the influence of using N-AcetylCysteyn (NAC) for prevention of AKI (Acute Kidney Injury) in post operatory of valve replacement until their discharge or death

Conditions

  • Surgery--Complications
  • Cardiac Valve Disease
  • Acute Kidney Injury
  • Oxygen Radical Damage
  • Post-Op Complication

Interventions

DRUG

N Acetyl Cysteine

Administrate NAC in the pre operatory and intra operatory moments and assess the influence in the outcomes

DRUG

Placebos

These participants will receive a saline solution in pre operatory with the same volume as the experimental group, and this solution will be administrated in 2 hours. During the surgery they will receive a new solution with the same volume of the experimental group, and this solution will be administrated in 6 hours too. The solutions will be covered by an opaque bag, so the participant will not see what is being administrated

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • José J Galvão de Lima, PhD · USP InCor

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2019-03-15
Completion
2020-03-15

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 NCT03440268 on ClinicalTrials.gov