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

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Goal-directed therapy
Sponsored by
Barretos Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring Goal Directed Therapy, Acute Kidney Injury

Eligibility Criteria

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

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    Control group

    Arm Description

    Goal-directed therapy

    Control group

    Outcomes

    Primary Outcome Measures

    acute kidney injury

    Secondary Outcome Measures

    death

    Full Information

    First Posted
    April 8, 2015
    Last Updated
    April 8, 2015
    Sponsor
    Barretos Cancer Hospital
    Collaborators
    Hospital de Base, Hospital do Servidor Publico Estadual, University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02414906
    Brief Title
    Goal Directed Therapy for Acute Kidney Injury in Critical Ill Patients
    Acronym
    GDT-AKIN
    Official Title
    Goal Directed Therapy in the Early Phase of Acute Kidney Injury in Critical Ill Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2010 (undefined)
    Primary Completion Date
    February 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Barretos Cancer Hospital
    Collaborators
    Hospital de Base, Hospital do Servidor Publico Estadual, University of Sao Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Kidney Injury
    Keywords
    Goal Directed Therapy, Acute Kidney Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    99 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Goal-directed therapy
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Control group
    Intervention Type
    Other
    Intervention Name(s)
    Goal-directed therapy
    Other Intervention Name(s)
    Protocol of ressuscitation
    Intervention Description
    Goal-directed therapy with fluids and dobutamine
    Primary Outcome Measure Information:
    Title
    acute kidney injury
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    death
    Time Frame
    2 months
    Other Pre-specified Outcome Measures:
    Title
    lenght of stay
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30379222
    Citation
    Amendola CP, Silva-Jr JM, Carvalho T, Sanches LC, Silva UVAE, Almeida R, Burdmann E, Lima E, Barbosa FF, Ferreira RS, Carmona MJC, Malbouisson LMS, Nogueira FAM, Auler-Junior JOC, Lobo SM. Goal-directed therapy in patients with early acute kidney injury: a multicenter randomized controlled trial. Clinics (Sao Paulo). 2018 Oct 29;73:e327. doi: 10.6061/clinics/2018/e327.
    Results Reference
    derived

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    Goal Directed Therapy for Acute Kidney Injury in Critical Ill Patients

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