Goal Direct Therapy to Prevent Acute Kidney Injury (GDT-AKI)

University of Sao Paulo

Status: Unknown

Conditions: Acute Kidney Injury

Treatments: Other: Goal Direct Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02396901

SDC 4163/14/143

Details and patient eligibility

About

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

Full 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).

Enrollment: 214 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 2 patient groups, including a placebo group

GDT group

Experimental group

Description:

Patients randomized to the GDT Group will care from a protective strategy with the suspension of angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB) 48 hours before surgery and receive hydration with lactated Ringer's solution at the rate of 1 mL/kg/h in the night before the surgery until the surgical procedure and perioperative hemodynamic therapy.

Treatment:

Other: Goal Direct Therapy

Control group

Placebo Comparator group

Description:

Patients randomized to the control group will be treated in accordance with the care in the institution's routine.