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Completed

NCT Number: NCT02414906

Goal Directed Therapy for 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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Goal-Directed Therapy

Other

Goal-directed therapy with fluids and dobutamine

Other names: Protocol of ressuscitation

Primary outcomes

  1. acute kidney injury

    Time frame: 2 months

Secondary outcomes

  1. death

    Time frame: 2 months

Other outcomes

  1. lenght of stay

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Barretos Cancer Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: GDT-AKIN

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Apr 13, 2015
Registry last updated
Apr 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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