Goal Direct Therapy to Prevent Acute Kidney Injury

Goal Direct Therapy to Prevent Acute Kidney Injury After Cardiac Surgery

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02396901

Acronym

GDT-AKI

Enrollment

214

Registered

2015-03-24

Start date

2015-04-30

Completion date

2017-04-30

Last updated

2015-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

early goal direct therapy, preventive strategies, cardiac surgery

Brief summary

This is an randomised controlled trial to investigate an strategy based in a protocol in prevention of acute kidney injury after cardiac surgery.

Detailed description

This is a prospective, randomized controlled trial to assess the influence of use of angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB) in the development of the Acute Kidney Injury in the postoperative period of cardiac surgery. Patients undergoing cardiac surgery at the Heart Institute (InCor) - Brazil, will be randomized and in accordance with a list of random numbers, generated by a computer program, will be allocated in one of the groups (GDT or standard).

Interventions

OTHERGoal Direct Therapy

Goal Direct Therapy - in this group patients will receive the standard treatment according with institutional protocol.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Cardiac surgery with Cardiopulmonary Bypass (CPB); Age greater than 18 years; Chronic kidney disease stages 3 and 4 (GFR less than 60 mL/min and greater than 15 mL/min); Sign the informed consent form.

Exclusion criteria

* Chronic renal insufficiency (GFR less than 15 mL/min); Heart surgery without CPB; Aortic procedures; Heart transplant or congenital heart disease; Prior use of Intra-Aortic Balloon Pump; Decompensated heart failure; Participation in other research protocol.

Design outcomes

Primary

Measure	Time frame	Description
Acute Kidney Injury	Within 48h after cardiac surgery	Development of acute kidney injury according to AKIN (Acute Kidney Injury Network) criterion.

Secondary

Measure	Time frame	Description
Serious clinical complications	For 28 days	Defined according to the guidelines of the Society of Thoracic Surgeons and include: stroke, need for invasive mechanical ventilation for more than 48 hours, mediastinitis, or deep infection of the surgical wound, mortality, need for reoperation.

Contacts

Primary ContactEduesley Santana-Santos, RN, Ph.D

eduesley@oi.com.br+551126615434

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026