Acute Kidney InjuryPhase 2GDT-AKINNCT02414906
Goal Directed Therapy for Acute Kidney Injury in Critical Ill Patients
A Phase 2 study testing Goal-directed therapy in people with Acute Kidney Injury, run by Barretos Cancer Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Goal-directed therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
About this study
Official title: Goal Directed Therapy in the Early Phase of 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.
Read the 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.
- Conditions
- Acute Kidney Injury
- Being tested
- Goal-directed therapy
- Keywords
- Goal Directed Therapy, Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-directed therapyOther
Also called Protocol of ressuscitation
Goal-directed therapy with fluids and dobutamine
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Goal-directed therapy Receives: Other: Goal-directed therapy |
| Control group | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute kidney injury
Measured: 2 months
Secondary outcomes (1)
death
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2015 (estimated)
- Study startJun 2010
- Primary completionFeb 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Base, Hospital do Servidor Publico Estadual, University of Sao Paulo
- Responsible party
- Principal investigator, Cristina Prata Amendola, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414906
- Sponsor's protocol ID
- BarretosCH-UTI 1
- Acronym
- GDT-AKIN
- Status last verified
- Mar 2015
- First submitted
- 8 Apr 2015
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30379222
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal Directed Therapy in the Early Phase of Acute Kidney Injury in Critical Ill Patients
- ClinicalTrials.gov ID
- NCT02414906
- Acronym / sponsor ID
- GDT-AKIN / BarretosCH-UTI 1
- Conditions
- Acute Kidney Injury
- Keywords
- Goal Directed Therapy, Acute Kidney Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Collaborators
- Hospital de Base, Hospital do Servidor Publico Estadual, University of Sao Paulo
- Study start
- Jun 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Goal-directed therapyGoal-directed therapy |
| Control group | No intervention | –Control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal-directed therapyAlso: Protocol of ressuscitationGoal-directed therapy with fluids and dobutamine | Other | Intervention group |
Primary outcome
acute kidney injury
Time frame: 2 months
1 secondary outcome
death
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
- Derived from this study: PubMed 30379222Amendola 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Goal-directed therapy in people with Acute Kidney Injury, run by Barretos Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute kidney injury (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02414906, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2015.