Acute Kidney InjuryNCT03509935
Use of Bedside Ultrasonography on the Incidence of Acute Renal Failure in High-risk Surgical Patients
A study testing Intervention Ultrasound Group in people with Acute Kidney Injury, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
The mortality and postoperative complications of high risk surgeries vary in the different series. The management of this group of patients in intensive care unit (ICU) is fundamental to improve these outcomes. 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?
- Intervention Ultrasound Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Mar 2018to 31 Mar 2019
- Phase
- Interventional
- 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
- Age equal or superior to 18 years.
- Major surgeries requiring ICU admission associated with one of the following criteria:
- Use of vasoactive drugs
- Use of inotropic drugs
- Mean blood pressure less than 65 mmHg or SBP <90 mmHg.
- Hyperlactatemia> 2 mmol / L
Show all 12Show fewer
- Heart rate> 90 bpm.
- Invasive mechanical ventilation required for at least 6 hours at the time of inclusion.
- Hypoxia: satO2 <92% in ambient air.
- Length of surgery greater than 4 hours.
- Request for transfusion of blood products in a surgical block
- Oliguria during procedure, defined as diuresis <0.5 ml/kg/h.
Who cannot join
- Patients who do not agree to the terms of the
- Dying patients with impending death in the first 24 hours
- Patients in a previous renal replacement therapy program
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas - Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais
About this study
Official title: Use of Bedside Ultrasonography on the Incidence of Acute Renal Failure in High-risk Surgical Patients: Randomized Clinical Trial
The mortality and postoperative complications of high risk surgeries vary in the different series. The management of this group of patients in intensive care unit (ICU) is fundamental to improve these outcomes. The objective of this study will be to evaluate whether the use of bedside ultrasound has an impact on the management of this group of patients with a consequent reduction in the incidence of acute renal failure in ICU and, secondarily, the incidence of associated complications. All adult patients (≥ 18 years old) admitted to ICU at Hospital das Clinicas of UFMG in the immediate postoperative period of major surgery with indication of ICU monitoring will be included and randomly randomized to the control or intervention group. The control group will be conducted by the intensive care physicians in charge without the US, while the second group will be conducted based in US findings. The US protocol will consist of a pulmonary US in four windows in each hemithorax , qualitative assessment of contractility and variation of inferior vena cava diameter. The primary outcome will be the development of acute renal failure as measured by the KDIGO score. Secondary outcomes will be length of ICU and hospital stay, ICU and 28 days mortality, length spent in mechanical ventilation, accumulated water balance, noradrenaline and dobutamine dose. Serum and urinary biomarkers will also be evaluated. Key words: ultrasound, high-risk surgery, intensive care
Read the detailed description
This is a single-center randomized clinical trial to be performed at the Adult Intensive Care Unit (ICU) of the Clinical Hospital of the Federal University of Minas Gerais, Belo Horizonte. The ICU is a clinical-surgical unit that has 18 beds with admission of approximately 100 patients per month, being 70% surgical patients and 30% clinical patients. Postoperative patients who meet the inclusion criteria reported below will be randomized to guide therapy according to ultrasound findings at the bedside versus a group that will not perform this method. Serum and urine samples will be collected in three times: admission (T0), after 12 hours (T1) and after 24 hours (T2) to analysed urine and serum biomarkers.
- Conditions
- Acute Kidney Injury
- Being tested
- Intervention Ultrasound Group
- Keywords
- ultrasound,, high-risk surgery, intensive care
- 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.
Intervention Ultrasound GroupOther
Protocol:
- US 4 pulmonary quadrants in each hemithorax: anterior and lateral, upper and lower regions (figure 1)
- US inferior vena cava, collaborative index or distensibility according to the patient's conditions, in spontaneous or controlled ventilation, respectively.
- Cardiac US: subjective evaluation of contractility in normal, discreetly reduced or severely reduced.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Ultrasound Group | Experimental | Patients will be submitted to Ultrasound protocol, namely:
1. In the first 6 to 12 hours of admission to ICU
2. Second US after 12-24 hours of inclusion.
3. Third US after 24-48 hours of inclusion.
Protocol:
* US 4 pulmonary quadrants in each hemithorax: anterior and lateral, upper and lower regions.
* US inferior vena cava, collapsability or distensibility index according to the patient's conditions, in spontaneous or controlled ventilation, respectively.
* Cardiac US: subjective evaluation of contractility between normal, reduced or severely reduced.
The US findings will be communicated to the attending physicians who will conduct the patient, according to the protocol, recommending the administration of volume or not, and the use of vasopressors and/or inotropic drugs. Receives: Other: Intervention Ultrasound Group |
| Control Group | No intervention | Patients randomized to this group will receive care according to the indication of the attending physicians, composed mainly of intensive care physicians, without bedside US. Patients may be submitted to echocardiographic, abdominal and vascular examinations, among others, requested to ultrasound service, according to the indication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute renal failure (ARF)
Creatinine elevation or oliguria according to KDIGO classification Impact in the incidence of ARF in major surgeries
Measured: One week
Secondary outcomes (8)
Volume replacement within the first 36 hours.
Quantity of volume administered during first 36 hours of admission in ICU
Measured: 36 hours
Use of vasopressor drugs.
vasopressor drugs requirement mcg/kg/min
Measured: 36 hours
Use of inotropic drugs.
Inotropic drug requirement in mcg/kg/min
Measured: 36hours
Length of invasive mechanical ventilation
Days spent in invasive mechanical ventilation
Measured: 36 hours
Length of ICU stay
Days spent in ICU
Measured: 28 days
Length of Hospital stay
Days spent in Hospital
Measured: 28 days
Mortality in ICU
Any cause of mortality during ICU stay
Measured: 28 days
28 days mortality
Any cause of mortality in 28 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start12 Mar 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vandack Alencar Nobre, Federal University of Minas Gerais
- Investigators
- Vandack Nobre, PhD, Principal investigator, Hospital das Clincias UFMG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509935
- Sponsor's protocol ID
- US to guide ressuscitation
- Status last verified
- Apr 2018
- First submitted
- 12 Apr 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Bedside Ultrasonography on the Incidence of Acute Renal Failure in High-risk Surgical Patients: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03509935
- Acronym / sponsor ID
- US to guide ressuscitation
- Conditions
- Acute Kidney Injury
- Keywords
- ultrasound,, high-risk surgery, intensive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 27 Apr 2018 (actual)
- 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.
The mortality and postoperative complications of high risk surgeries vary in the different series. The management of this group of patients in intensive care unit (ICU) is fundamental to improve these outcomes. The objective of this study will be to evaluate whether the use of bedside ultrasound has an impact on the management of this group of patients with a consequent reduction in the incidence of acute renal failure in ICU and, secondarily, the incidence of associated complications. All adult patients (≥ 18 years old) admitted to ICU at Hospital das Clinicas of UFMG in the immediate postoperative period of major surgery with indication of ICU monitoring will be included and randomly randomized to the control or intervention group. The control group will be conducted by the intensive care physicians in charge without the US, while the second group will be conducted based in US findings. The US protocol will consist of a pulmonary US in four windows in each hemithorax , qualitative assessment of contractility and variation of inferior vena cava diameter. The primary outcome will be the development of acute renal failure as measured by the KDIGO score. Secondary outcomes will be length of ICU and hospital stay, ICU and 28 days mortality, length spent in mechanical ventilation, accumulated water balance, noradrenaline and dobutamine dose. Serum and urinary biomarkers will also be evaluated. Key words: ultrasound, high-risk surgery, intensive care
Detailed description
This is a single-center randomized clinical trial to be performed at the Adult Intensive Care Unit (ICU) of the Clinical Hospital of the Federal University of Minas Gerais, Belo Horizonte. The ICU is a clinical-surgical unit that has 18 beds with admission of approximately 100 patients per month, being 70% surgical patients and 30% clinical patients. Postoperative patients who meet the inclusion criteria reported below will be randomized to guide therapy according to ultrasound findings at the bedside versus a group that will not perform this method. Serum and urine samples will be collected in three times: admission (T0), after 12 hours (T1) and after 24 hours (T2) to analysed urine and serum biomarkers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Ultrasound Group | Experimental | Other: Intervention Ultrasound GroupPatients will be submitted to Ultrasound protocol, namely: 1. In the first 6 to 12 hours of admission to ICU 2. Second US after 12-24 hours of inclusion. 3. Third US after 24-48 hours of inclusion. Protocol: * US 4 pulmonary quadrants in each hemithorax: anterior and lateral, upper and lower regions. * US inferior vena cava, collapsability or distensibility index according to the patient's conditions, in spontaneous or controlled ventilation, respectively. * Cardiac US: subjective evaluation of contractility between normal, reduced or severely reduced. The US findings will be communicated to the attending physicians who will conduct the patient, according to the protocol, recommending the administration of volume or not, and the use of vasopressors and/or inotropic drugs. |
| Control Group | No intervention | –Patients randomized to this group will receive care according to the indication of the attending physicians, composed mainly of intensive care physicians, without bedside US. Patients may be submitted to echocardiographic, abdominal and vascular examinations, among others, requested to ultrasound service, according to the indication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age equal or superior to 18 years.
- Major surgeries requiring ICU admission associated with one of the following criteria:
Key exclusion criteria (3 listed)
- Patients who do not agree to the terms of the
- Dying patients with impending death in the first 24 hours
- Patients in a previous renal replacement therapy program
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 |
|---|---|---|
| Intervention Ultrasound GroupProtocol: * US 4 pulmonary quadrants in each hemithorax: anterior and lateral, upper and lower regions (figure 1) * US inferior vena cava, collaborative index or distensibility according to the patient's conditions, in spontaneous or controlled ventilation, respectively. * Cardiac US: subjective evaluation of contractility in normal, discreetly reduced or severely reduced. | Other | Intervention Ultrasound Group |
Primary outcome
Acute renal failure (ARF)
Time frame: One week
Creatinine elevation or oliguria according to KDIGO classification Impact in the incidence of ARF in major surgeries
8 secondary outcomes
Volume replacement within the first 36 hours.
Time frame: 36 hours
Use of vasopressor drugs.
Time frame: 36 hours
Use of inotropic drugs.
Time frame: 36hours
Length of invasive mechanical ventilation
Time frame: 36 hours
Length of ICU stay
Time frame: 28 days
Length of Hospital stay
Time frame: 28 days
Mortality in ICU
Time frame: 28 days
28 days mortality
Time frame: 28 days
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 22 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Vandack Nobre, PhD principal investigator
Hospital das Clincias UFMG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Ultrasound Group in people with Acute Kidney Injury, run by Federal University of Minas Gerais at 1 site in Brazil.
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 12 inclusion and 3 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 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 renal failure (ARF) (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2020.