Goal Directed Therapy for Acute Kidney Injury in Critical Ill Patients

Acute Kidney Injury Clinical Trial

— GDT-AKIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414906
• Other study ID #: BarretosCH-UTI 1
• Status: Completed
• Phase: Phase 2
• First received: April 8, 2015
• Last updated: April 8, 2015
• Start date: June 2010
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Barretos Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Other:
• Goal-directed therapy
Goal-directed therapy with fluids and dobutamine

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Barretos Cancer Hospital	Hospital de Base, Hospital do Servidor Publico Estadual, University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	lenght of stay		2 months	No
Primary	acute kidney injury		2 months	No
Secondary	death		2 months	No