Acute Kidney InjuryCOOBrANCT04444765
Hemodynamic and Respiratory Tolerance of Intermittent Hemodialysis in Critically Ill Patients
An observational study of Acute Kidney Injury, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Acute kidney injury (AKI) affects up to 30% of critically ill patients and is associated with increased rates of mortality. Up to 60% of patients with AKI will ultimately require renal replacement therapy (RRT). Intermittent hemodialysis (IHD) is one of the main methods of RRT worldwide. 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?
- Collection of clinical and biological data during renal replacement therapy sessions
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 23 Apr 2020to 31 Dec 2022
- Phase
- Observational
- 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
Study population: Patients with acute kidney injury
Who may be able to join
- Patients ≥ 18 years old
- Invasive monitoring of blood pressure
- Non opposition to the research
- Admission to the intensive care unit
- Need of intermittent hemodialysis
Who cannot join
- Sodium bicarbonate infusion
- Pregnancy or breastfeeding
- Juridical protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic and Respiratory Tolerance of Intermittent Hemodialysis (Acetate Free Biofiltration and Bicarbonate-based Intermittent Dialysis) in Critically Ill Patients
Acute kidney injury (AKI) affects up to 30% of critically ill patients and is associated with increased rates of mortality. Up to 60% of patients with AKI will ultimately require renal replacement therapy (RRT). Intermittent hemodialysis (IHD) is one of the main methods of RRT worldwide. In IHD-bicar, dialysate is composed by electrolytes, including calcium, and bicarbonate. To avoid calcium carbonate precipitation, dialysate has to be supplemented with acids (citric acid, chloride acid or acetic acid). However, IHD-bicar may be associated with hemodynamic instability or respiratory intolerance, mainly related to the CO2 release in the circulation during IHD (HCO3- <--> CO2 + H2O). Some recent studies showed that acetate free biofiltration (AFB-K), a technique that does not require dialysate acidification, could be associated with better hemodynamic stability and to a lower amount of CO2 delivered to the patients. AFB-K may thus improve the hemodynamic and respiratory tolerance of intermittent RRT in critically ill patients.
Read the detailed description
In this prospective observational study, investigators aim to characterize the hemodynamic and respiratory tolerances of HDI-bicar and AFB-K in critically ill patients requiring RRT.
- Conditions
- Acute Kidney Injury
- Being tested
- Collection of clinical and biological data during renal replacement therapy sessions
- Keywords
- Acute kidney injury, renal replacement therapy, acetate free biofiltration, bicarbonate-based hemodialysis, C02 removal, intensive care unit, critical 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.
Collection of clinical and biological data during renal replacement therapy sessionsOther
Collection of clinical and biological data during renal replacement therapy sessions. Two additional blood samples collected during and after RRT session (critically ill patients all have arterial catheter thus additional samples will not need additional puncture).
| Study group | Role | What they receive |
|---|---|---|
| Patients with bicarbonate-based intermittent dialysis | Dialysate is composed by electrolytes, including calcium, and bicarbonate. To avoid calcium carbonate precipitation, dialysate has to be supplemented with acids (citric acid, chloride acid or acetic acid). Receives: Other: Collection of clinical and biological data during renal replacement therapy sessions | |
| Patients with acetate free biofiltration dialysis | Acetate free biofiltration (AFB-K)is a technique that does not require dialysate acidification Receives: Other: Collection of clinical and biological data during renal replacement therapy sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of hemodynamic event
The occurrence of at least one of the following events will be considered a hemodynamic event :
- Hypotension (decrease of systolic or mean blood pressures ≥ 15 and ≥ 10% respectively)
- Tachycardia (increase of heart beating ≥ 20%)
- Cardiac arrythmia (junctional tachycardia, atrial fibrillation, flutter, ventricular tachycardia or fibrillation)
- Decrease of the cardiac output ≥ 15% (only in patients with invasive cardiac output monitoring)
- Starting (or increase dosing) of norepinephrine ≥ 0.1 µg/kg/min
Measured: From admission to discharge, up to 4 hours
Secondary outcomes (4)
Change in maximal PaCO2
Evaluation of PaCO2 by arterial blood gas test
Measured: 1 hour after the beginning of dialysis , up to 4 hours
Maximum difference of tcPCO2 and etCO2
Evaluation of TcPCO2 and etCO2 by trans-cutaneous measurement
Measured: From admission to discharge, up to 4 hours
Change in the "strong ion difference"
Evaluation of the "strong ion difference" by blood ionogram
Measured: baseline, 4 hours
Change in plasma pH
Evaluation of plasma pH by blood ionogram
Measured: 1 hour after the beginning of dialysis session, up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start23 Apr 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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.
- More trials run by University Hospital, ToulouseThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stanislas Faguer, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444765
- Sponsor's protocol ID
- RC31/19/0496
- Acronym
- COOBrA
- Status last verified
- Jul 2023
- First submitted
- 29 May 2020
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic and Respiratory Tolerance of Intermittent Hemodialysis (Acetate Free Biofiltration and Bicarbonate-based Intermittent Dialysis) in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT04444765
- Acronym / sponsor ID
- COOBrA / RC31/19/0496
- Conditions
- Acute Kidney Injury
- Keywords
- Acute kidney injury, renal replacement therapy, acetate free biofiltration, bicarbonate-based hemodialysis, C02 removal, intensive care unit, critical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 Jun 2020 (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.
Acute kidney injury (AKI) affects up to 30% of critically ill patients and is associated with increased rates of mortality. Up to 60% of patients with AKI will ultimately require renal replacement therapy (RRT). Intermittent hemodialysis (IHD) is one of the main methods of RRT worldwide. In IHD-bicar, dialysate is composed by electrolytes, including calcium, and bicarbonate. To avoid calcium carbonate precipitation, dialysate has to be supplemented with acids (citric acid, chloride acid or acetic acid). However, IHD-bicar may be associated with hemodynamic instability or respiratory intolerance, mainly related to the CO2 release in the circulation during IHD (HCO3- <--> CO2 + H2O). Some recent studies showed that acetate free biofiltration (AFB-K), a technique that does not require dialysate acidification, could be associated with better hemodynamic stability and to a lower amount of CO2 delivered to the patients. AFB-K may thus improve the hemodynamic and respiratory tolerance of intermittent RRT in critically ill patients.
Detailed description
In this prospective observational study, investigators aim to characterize the hemodynamic and respiratory tolerances of HDI-bicar and AFB-K in critically ill patients requiring RRT.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with bicarbonate-based intermittent dialysis | – | Other: Collection of clinical and biological data during renal replacement therapy sessionsDialysate is composed by electrolytes, including calcium, and bicarbonate. To avoid calcium carbonate precipitation, dialysate has to be supplemented with acids (citric acid, chloride acid or acetic acid). |
| Patients with acetate free biofiltration dialysis | – | Other: Collection of clinical and biological data during renal replacement therapy sessionsAcetate free biofiltration (AFB-K)is a technique that does not require dialysate acidification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute kidney injury
Key inclusion criteria (5 listed)
- Patients ≥ 18 years old
- Invasive monitoring of blood pressure
- Non opposition to the research
- Admission to the intensive care unit
- Need of intermittent hemodialysis
Key exclusion criteria (3 listed)
- Sodium bicarbonate infusion
- Pregnancy or breastfeeding
- Juridical protection
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 |
|---|---|---|
| Collection of clinical and biological data during renal replacement therapy sessionsCollection of clinical and biological data during renal replacement therapy sessions. Two additional blood samples collected during and after RRT session (critically ill patients all have arterial catheter thus additional samples will not need additional puncture). | Other | Patients with acetate free biofiltration dialysis, Patients with bicarbonate-based intermittent dialysis |
Primary outcome
Occurence of hemodynamic event
Time frame: From admission to discharge, up to 4 hours
The occurrence of at least one of the following events will be considered a hemodynamic event : * Hypotension (decrease of systolic or mean blood pressures ≥ 15 and ≥ 10% respectively) * Tachycardia (increase of heart beating ≥ 20%) * Cardiac arrythmia (junctional tachycardia, atrial fibrillation, flutter, ventricular tachycardia or fibrillation) * Decrease of the cardiac output ≥ 15% (only in patients with invasive cardiac output monitoring) * Starting (or increase dosing) of norepinephrine ≥ 0.1 µg/kg/min
4 secondary outcomes
Change in maximal PaCO2
Time frame: 1 hour after the beginning of dialysis , up to 4 hours
Maximum difference of tcPCO2 and etCO2
Time frame: From admission to discharge, up to 4 hours
Change in the "strong ion difference"
Time frame: baseline, 4 hours
Change in plasma pH
Time frame: 1 hour after the beginning of dialysis session, up to 4 hours
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 28 Jul 2023.
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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.
Stanislas Faguer, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by University Hospital, Toulouse at 1 site in France.
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 5 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 28 Jul 2023. 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 France. 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?
Occurence of hemodynamic event (time frame: From admission to discharge, up to 4 hours). 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 28 Jul 2023.