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

Primary Purpose

Acute Kidney Injury

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Goal Direct Therapy

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring early goal direct therapy, preventive strategies, cardiac surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GDT group

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

Acute Kidney Injury

Development of acute kidney injury according to AKIN (Acute Kidney Injury Network) criterion.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02396901

First Posted

March 12, 2015

Last Updated

March 17, 2015

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT02396901

Brief Title

Goal Direct Therapy to Prevent Acute Kidney Injury

Acronym

GDT-AKI

Official Title

Goal Direct Therapy to Prevent Acute Kidney Injury After Cardiac Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Unknown status

Study Start Date

April 2015 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury

Keywords

early goal direct therapy, preventive strategies, cardiac surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

214 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GDT group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Goal Direct Therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Acute Kidney Injury

Description

Development of acute kidney injury according to AKIN (Acute Kidney Injury Network) criterion.

Time Frame

Within 48h after cardiac surgery

Secondary Outcome Measure Information:

Title

Serious clinical complications

Description

Time Frame

For 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eduesley Santana-Santos, RN, Ph.D

Phone

+551126615434

eduesley@oi.com.br

12. IPD Sharing Statement

Citations:

PubMed Identifier

8872955

Citation

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Goal Direct Therapy to Prevent Acute Kidney Injury

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