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

Sponsor
Barretos Cancer Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02414906
Collaborator
Hospital de Base (Other), Hospital do Servidor Publico Estadual (Other), University of Sao Paulo (Other)
99
Enrollment
2
Arms
54
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Goal-directed therapy
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
99 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Goal Directed Therapy in the Early Phase of Acute Kidney Injury in Critical Ill Patients
Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

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

    Control group

    Outcome Measures

    Primary Outcome Measures

    1. acute kidney injury [2 months]

    Secondary Outcome Measures

    1. death [2 months]

    Other Outcome Measures

    1. lenght of stay [2 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Barretos Cancer Hospital
    • Hospital de Base
    • Hospital do Servidor Publico Estadual
    • University of Sao Paulo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cristina Prata Amendola, MD, Barretos Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT02414906
    Other Study ID Numbers:
    • BarretosCH-UTI 1
    First Posted:
    Apr 13, 2015
    Last Update Posted:
    Apr 13, 2015
    Last Verified:
    Mar 1, 2015
    Keywords provided by Cristina Prata Amendola, MD, Barretos Cancer Hospital
    Goal Directed Therapy
    Acute Kidney Injury
    Additional relevant MeSH terms:
    Acute Kidney Injury
    Wounds and Injuries

    Study Results

    No Results Posted as of Apr 13, 2015