Septic Acute Kidney InjuryNCT02384525
The Assessment of Volume Status by BIA and Lung Ultrasound in Septic AKI Patients Undergoing CRRT
A study testing Fluid management by the value of over hydration in Bioelectrical impedance and Fluid management by clinical-based ultrafiltration in people with Septic Acute Kidney Injury, run by Yonsei University at 1 site in South Korea.
Trial summary
Acute kidney injury(AKI) is one of the most common complications that occur up to 35% of critically ill patients. Septic AKI accounts for one third of them. Patients with septic AKI are widely treated with Continuous renal replacement therapy (CRRT). Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Septic Acute Kidney Injury
- What is being tested?
- Fluid management by the value of over hydration in Bioelectrical impedance and Fluid management by clinical-based ultrafiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2017to Nov 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- body temperature < 36 °C or > 38 °C
- heart rate > 90 BPM
- respiratory rate > 20 or aPaCO2 < 32 mmHg on ABG
- White blood cell count < 4,000 cells/mm3 or > 12,000 cells/mm3 or band forms (immature white blood cells) ≥10%
- Evidence of infection
- WBCs in normally sterile fluid
Show all 11Show fewer
- Perforated viscus
- radiologically proven infection
- more than Injury stage in AKI according to RIFLE criteria
- septic AKI which is not explained by other cause
- patients signed a written informed consent.
Who cannot join
- Younger than 19 years old, older than 80 years old
- Previously undergoing dialysis treatment due to ESRD
- Underlying malignancy, Life expectancy shorter than 3 month
- AKI due to other than sepsis
- patients with intracardiac device such as Pacemaker, CRT, ICD
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, 120-752
Tae Hyun Yoo, MD, 82-2-2228-1989, YOOSY0316@yuhs.ac
About this study
Acute kidney injury(AKI) is one of the most common complications that occur up to 35% of critically ill patients. Septic AKI accounts for one third of them. Patients with septic AKI are widely treated with Continuous renal replacement therapy (CRRT). However, previous studies have hardly documented improvement of mortality in septic AKI patients. Otherwise, Fluid overload in septic shock patients who are undergoing CRRT is proven to be a significant predictor for mortality. Recent studies showed efficacy of bioelectrical impedance analysis and lung ultrasound in assessing fluid status of the patients. Thus, hypothesis of the study is that fluid assessment and control of fluid status using BIA and Lung Ultrasound could be related to the outcome of septic AKI patients who undergo CRRT. In this study, the investigators measure the fluid status of the patients by bioelectrical impedance analysis and lung ultrasound for experimental group, while for control group, fluid status would be determined clinically by the physician. Ultrafiltration rate of experimental group is adjusted to be equal to the value of overhydration measured by BIA.
- Conditions
- Septic Acute Kidney Injury
- Being tested
- Fluid management by the value of over hydration in Bioelectrical impedance, Fluid management by clinical-based ultrafiltration
- Keywords
- Septic AKI, CRRT, BIA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid management by the value of over hydration in Bioelectrical impedanceProcedure or surgery
In this study, investigator measure the fluid status of the patients by bioelectrical impedance analysis and lung ultrasound. The patients are assigned into two groups, BIA and Lung Ultrasound based versus clinical-based assessment group. Ultrafiltration of BIA and Lung Ultrasound based group is adjusted to be equal to the value of over hydration measured only by BIA, not by Lung Ultrasound, because Lung Ultrasound cannot determine exact amount of the patient's fluid excess. Total amount of ultrafiltration will be removed from the patient for three days evenly. On the other hand, Ultrafiltration amount will be decided by the physician in the clinical based group. Amount of fluid removal for a day will be adjusted not to exceed 2000ml, so that total fluid removed from the patient will not exceed 6000ml for three days.
Fluid management by clinical-based ultrafiltrationProcedure or surgery
In this study, investigator measure the fluid status of the patients by bioelectrical impedance analysis and lung ultrasound. The patients are assigned into two groups, BIA and Lung Ultrasound based versus clinical-based assessment group. Ultrafiltration of BIA and Lung Ultrasound based group is adjusted to be equal to the value of over hydration measured only by BIA, not by Lung Ultrasound, because Lung Ultrasound cannot determine exact amount of the patient's fluid excess. Total amount of ultrafiltration will be removed from the patient for three days evenly. On the other hand, Ultrafiltration amount will be decided by the physician in the clinical based group. Amount of fluid removal for a day will be adjusted not to exceed 2000ml, so that total fluid removed from the patient will not exceed 6000ml for three days.
| Study group | Role | What they receive |
|---|---|---|
| clinical-based ultrafiltration | Experimental | Not described Receives: Procedure: Fluid management by the value of over hydration in Bioelectrical impedance |
| BIA-based ultrafiltration | Active comparator | Not described Receives: Procedure: Fluid management by clinical-based ultrafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all cause mortality
Measured: 28th day from CRRT
Secondary outcomes (1)
Dialysis free rate
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study start1 Jan 2017
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384525
- Sponsor's protocol ID
- 4-2014-0791
- Status last verified
- Jan 2019
- First submitted
- 26 Feb 2015
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Volume Status by BIA and Lung Ultrasound in Septic AKI Patients Undergoing CRRT
- ClinicalTrials.gov ID
- NCT02384525
- Acronym / sponsor ID
- 4-2014-0791
- Conditions
- Septic Acute Kidney Injury
- Keywords
- Septic AKI, CRRT, BIA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 10 Mar 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 one of the most common complications that occur up to 35% of critically ill patients. Septic AKI accounts for one third of them. Patients with septic AKI are widely treated with Continuous renal replacement therapy (CRRT). However, previous studies have hardly documented improvement of mortality in septic AKI patients. Otherwise, Fluid overload in septic shock patients who are undergoing CRRT is proven to be a significant predictor for mortality. Recent studies showed efficacy of bioelectrical impedance analysis and lung ultrasound in assessing fluid status of the patients. Thus, hypothesis of the study is that fluid assessment and control of fluid status using BIA and Lung Ultrasound could be related to the outcome of septic AKI patients who undergo CRRT. In this study, the investigators measure the fluid status of the patients by bioelectrical impedance analysis and lung ultrasound for experimental group, while for control group, fluid status would be determined clinically by the physician. Ultrafiltration rate of experimental group is adjusted to be equal to the value of overhydration measured by BIA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clinical-based ultrafiltration | Experimental | Procedure: Fluid management by the value of over hydration in Bioelectrical impedance |
| BIA-based ultrafiltration | Active comparator | Procedure: Fluid management by clinical-based ultrafiltration |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- body temperature < 36 °C or > 38 °C
- heart rate > 90 BPM
- respiratory rate > 20 or aPaCO2 < 32 mmHg on ABG
- White blood cell count < 4,000 cells/mm3 or > 12,000 cells/mm3 or band forms (immature white blood cells) ≥10%
- Evidence of infection
Key exclusion criteria (5 listed)
- Younger than 19 years old, older than 80 years old
- Previously undergoing dialysis treatment due to ESRD
- Underlying malignancy, Life expectancy shorter than 3 month
- AKI due to other than sepsis
- patients with intracardiac device such as Pacemaker, CRT, ICD
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 |
|---|---|---|
| Fluid management by the value of over hydration in Bioelectrical impedanceIn this study, investigator measure the fluid status of the patients by bioelectrical impedance analysis and lung ultrasound. The patients are assigned into two groups, BIA and Lung Ultrasound based versus clinical-based assessment group. Ultrafiltration of BIA and Lung Ultrasound based group is adjusted to be equal to the value of over hydration measured only by BIA, not by Lung Ultrasound, because Lung Ultrasound cannot determine exact amount of the patient's fluid excess. Total amount of ultrafiltration will be removed from the patient for three days evenly. On the other hand, Ultrafiltration amount will be decided by the physician in the clinical based group. Amount of fluid removal for a day will be adjusted not to exceed 2000ml, so that total fluid removed from the patient will not exceed 6000ml for three days. | Procedure or surgery | clinical-based ultrafiltration |
| Fluid management by clinical-based ultrafiltrationIn this study, investigator measure the fluid status of the patients by bioelectrical impedance analysis and lung ultrasound. The patients are assigned into two groups, BIA and Lung Ultrasound based versus clinical-based assessment group. Ultrafiltration of BIA and Lung Ultrasound based group is adjusted to be equal to the value of over hydration measured only by BIA, not by Lung Ultrasound, because Lung Ultrasound cannot determine exact amount of the patient's fluid excess. Total amount of ultrafiltration will be removed from the patient for three days evenly. On the other hand, Ultrafiltration amount will be decided by the physician in the clinical based group. Amount of fluid removal for a day will be adjusted not to exceed 2000ml, so that total fluid removed from the patient will not exceed 6000ml for three days. | Procedure or surgery | BIA-based ultrafiltration |
Primary outcome
28-day all cause mortality
Time frame: 28th day from CRRT
1 secondary outcome
Dialysis free rate
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid management by the value of over hydration in Bioelectrical impedance and Fluid management by clinical-based ultrafiltration in people with Septic Acute Kidney Injury, run by Yonsei University at 1 site in South Korea.
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 11 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Jan 2019. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae Hyun Yoo, MD (+82-2-2228-5345, yoosy0316@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day all cause mortality (time frame: 28th day from CRRT). 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 10 Jan 2019.