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

March 17, 2015 updated by: Eduesley Santana Santos, University of Sao Paulo

Goal Direct Therapy to Prevent Acute Kidney Injury After Cardiac Surgery

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Eduesley Santana-Santos, RN, Ph.D
  • Phone Number: +551126615434
  • Email: eduesley@oi.com.br

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Kidney Injury
Time Frame: Within 48h after cardiac surgery
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
Time Frame: 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.
For 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

March 12, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDC 4163/14/143

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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