Goal Directed Therapy for Acute Kidney Injury in Critical Ill Patients (GDT-AKIN)

April 8, 2015 updated by: Cristina Prata Amendola, Barretos Cancer Hospital

Goal Directed Therapy in the Early Phase of Acute Kidney Injury in Critical Ill Patients

Acute kidney injury (AKI) is a frequent complication in critically ill patients admitted to intensive care unit (ICU) and it is associated with increased morbimortality.

There is evidence that perioperative hemodynamic optimization decreases the incidence of AKI in the post operative phase in high-risk patients. We aimed to evaluate if the use of a goal-directed therapy to increase oxygen delivery in the early phase of acute kidney injury can decrease the prevalence of patients with acute renal failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized, controlled, multicenter study.The intervention group was monitored with Flo Trac/Vigileo and optimized with fluid challenges, dobutamine and blood transfusion, if necessary, to maintain a IDO² ≥600ml/min/m² during 8h. The control group was treated according to the discretion of the attending physician.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 2

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:

  • Patients admitted in the Intensive Care Unit with Acute Kidney Injury (AKI) classified as AKIN 1 (increase in serum creatinine ≥0.3 mg/dL and/or urine output less than 0.5 ml/kg/h over 6 hours) for less than 12 hours.

Exclusion Criteria:

  • ICU length of stay >10 days, nefrectomy, chronic kidney disease undergoing hemodialysis, baseline creatinine ≥4 mg/dL, life expectance ≤ than 1 month, pregnancy, severe arrhythmia, severe heart failure (≤ III, NYHA), acute myocardial infarction (AMI)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Goal-directed therapy
Other: Goal-directed therapy
Goal-directed therapy with fluids and dobutamine
Other Names:
  • Protocol of ressuscitation
No Intervention: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
acute kidney injury
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
death
Time Frame: 2 months
2 months

Other Outcome Measures

Outcome Measure
Time Frame
lenght of stay
Time Frame: 2 months
2 months

Collaborators and Investigators

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

Sponsor

Barretos Cancer Hospital

Collaborators

University of Sao Paulo
Hospital de Base
Hospital do Servidor Publico Estadual

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

June 1, 2010

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (Estimate)

April 13, 2015

Study Record Updates

Last Update Posted (Estimate)

April 13, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BarretosCH-UTI 1

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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