Clinical trial NCT02396901: Goal Direct Therapy to Prevent Acute Kidney Injury
Official title: Goal Direct Therapy to Prevent Acute Kidney Injury After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Kidney Injury
Keywords: early goal direct therapy
preventive strategies
cardiac surgery
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Acute Kidney Injury
timeFrame: Within 48h after cardiac surgery
Secondary outcomes:
measure: Serious clinical complications
timeFrame: For 28 days
Other outcomes:
Locations:
Study officials:
References:
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