Goal Directed Therapy for Acute Kidney Injury in Critical Ill Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

Goal-directed therapy

Group Type EXPERIMENTAL

Goal-directed therapy

Intervention Type OTHER

Goal-directed therapy with fluids and dobutamine

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Goal-directed therapy

Goal-directed therapy with fluids and dobutamine

Intervention Type OTHER

Other Intervention Names

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Protocol of ressuscitation

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No