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

NCT03440268 | Unknown Phase 4

• 1 other identifier: NAC Valve
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cardiac surgery; post operatory complications; Acute kidney injury; N-acetylcystein

Outcome Measures

Primary Outcomes (1)

• NAC and acute kidney injury (AKI)

  Assess the influence of using NAC in the incidence of AKI by using the Kidney diagnosis improving outcomes (KDIGO) score and Acute kidney injury network (AKIN) score that use the creatinine seric and urine output values to define if we can or not diagnosis acute kidney injury in this pacient. The incidence of AKI will be defined by KDIGO criterea: AKI if creatinine raises up to 1,5 times the baseline, until 7 days. Or if seric creatinine raises 0,3mg/dL up to baseline in 48 hours. Urine output: less than 0,5ml/kg/h for 6-12 hours AKIN criterea: AKI if creatinine raises up to 1,5 times the baseline, until 7 days. Or if seric creatinine raises 0,3mg/dL up to baseline in 48 hours. Urine output: less than 0,5ml/kg/h for 6-12 hours

  The participants will be assess in the day before the surgery (baseline), and daily until 7 days of post operatory

Secondary Outcomes (2)

• NAC and kidney replacement therapy (KRT)

  From the post operatory until the necessity of KRT, assessed up 2 months

• NAC and death

  From the post operatory until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 months

Study Arms (2)

N Acetyl Cysteine

EXPERIMENTAL

NAC in pre operatory 150mg/kg infusion in 2 hours. NAC during the surgery 50mg/kg in 6 hours. The influence of NAC will be assess in post operatory moment with routine exams

Drug: N Acetyl Cysteine

Placebos

PLACEBO COMPARATOR

Saline solution in pre operatory. Saline Solution duing the surgery. The post operatory datas of both groups will be compare

Drug: Placebos

Interventions

N Acetyl Cysteine DRUG

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

Also known as: NAC, experimental

N Acetyl Cysteine

Placebos DRUG

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

Also known as: control

Placebos

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults
• Both sex
• Elective replacement valve (mitral or aortic) procedure

You may not qualify if:

• Chronic dialysis patients
• Emergency procedures
• Percutaneous procedures
• Pregnants
• Oncologic patients

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

José Jayme Galvão de Lima

São Paulo, 05403-900, Brazil

Location

Related Publications (3)

• Spector A. Review: Oxidative stress and disease. J Ocul Pharmacol Ther. 2000 Apr;16(2):193-201. doi: 10.1089/jop.2000.16.193.

  PMID: 10803430 BACKGROUND

• Suen WS, Mok CK, Chiu SW, Cheung KL, Lee WT, Cheung D, Das SR, He GW. Risk factors for development of acute renal failure (ARF) requiring dialysis in patients undergoing cardiac surgery. Angiology. 1998 Oct;49(10):789-800. doi: 10.1177/000331979804900902.

  PMID: 9783643 RESULT

• Bahar I, Akgul A, Ozatik MA, Vural KM, Demirbag AE, Boran M, Tasdemir O. Acute renal failure following open heart surgery: risk factors and prognosis. Perfusion. 2005 Oct;20(6):317-22. doi: 10.1191/0267659105pf829oa.

  PMID: 16363316 RESULT

MeSH Terms

Conditions

Heart Valve Diseases; Acute Kidney Injury; Postoperative Complications

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• José J Galvão de Lima, PhD

  USP InCor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José J Galvão de Lima, PhD

CONTACT

1126615334; jose.lima@incor.usp.br

Felipe Kenji O Kamei, especialist

CONTACT

11997464073; fkok92@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant of the study won't know what is he receiving (placebo or NAC) and the assessor will not have any contact with the participants
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD (Nefrologist),PhD

Model Details: There will be one group placebo/control and one group intervention. The group intervention will receive the medication N AcetylCysteyn (NAC), while the control will receive a placebo

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: February 22, 2018
• Study Start: March 15, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2020
• Last Updated: March 5, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)