Goal Direct Therapy to Prevent Acute Kidney Injury

Study Overview
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Brief Summary
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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
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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).

Official Title
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Goal Direct Therapy to Prevent Acute Kidney Injury After Cardiac Surgery

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Other: Goal Direct Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GDT group<br>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. | Other: Goal Direct Therapy<br>* Goal Direct Therapy - in this group patients will receive the standard treatment according with institutional protocol.<br>|
| Placebo Comparator: Control group<br>Patients randomized to the control group will be treated in accordance with the care in the institution's routine. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious clinical complications | 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. | For 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early goal direct therapy, preventive strategies, cardiac surgery