Goal Directed Therapy for Acute Kidney Injury in Critical Ill Patients
GDT-AKIN
Goal Directed Therapy in the Early Phase of Acute Kidney Injury in Critical Ill Patients
1 other identifier
interventional
99
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2010
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 8, 2015
CompletedFirst Posted
Study publicly available on registry
April 13, 2015
CompletedApril 13, 2015
March 1, 2015
3.7 years
April 8, 2015
April 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
acute kidney injury
2 months
Secondary Outcomes (1)
death
2 months
Other Outcomes (1)
lenght of stay
2 months
Study Arms (2)
Intervention group
EXPERIMENTALGoal-directed therapy
Control group
NO INTERVENTIONControl group
Interventions
Goal-directed therapy with fluids and dobutamine
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Barretos Cancer Hospitallead
- Hospital de Basecollaborator
- Hospital do Servidor Publico Estadualcollaborator
- University of Sao Paulocollaborator
Related Publications (1)
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.
PMID: 30379222DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
April 8, 2015
First Posted
April 13, 2015
Study Start
June 1, 2010
Primary Completion
February 1, 2014
Study Completion
December 1, 2014
Last Updated
April 13, 2015
Record last verified: 2015-03