Acute Kidney InjuryBALANCENCT06483542
Bionenergetic Balance During CVVH
An observational study of Acute Kidney Injury and Continuous Venovenous Hemofiltration, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The bioenergetic balance is the sum of energy exchanged during CRRT and is mostly defined by citrate glucose and lactate. When CRRT was performed with the older dialysis fluids, glucose and lactate could be an important source of energy next to citrate when used as predilution (6, 7). Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Acute Kidney Injury, Continuous Venovenous Hemofiltration, Energy Metabolism
- What is being tested?
- bioenergetic balance
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2023to 30 Sep 2024
- 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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult critically ill patients with acute kidney injury who require CVVH
Who may be able to join
- Patients admitted to the adult ICU (01/01/2021-30/09/2022)
- At least one indirect calorimetry measurement (ventilator) or calculation based on harris benedict OR 25Kcal/kg/day
- Combined with bio energetic balance measurement
- Receiving CVVH during intensive care stay
Who cannot join
- Patients admitted outside of the inclusion period will be excluded
- The absence of an indirect calorimetry measurement (ventilator) or calculation - based on the Harris Benedict OR 25Kcal/kg/day formula OR The absence of a bio energetic balance measurement
- The absence of CVVH during intensive care stay
- Pediatric (intensive care unit) patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Analysis of the Impact of Non-nutritional Calories During Continuous Veno-Venous Hemofiltration
The bioenergetic balance is the sum of energy exchanged during CRRT and is mostly defined by citrate glucose and lactate. When CRRT was performed with the older dialysis fluids, glucose and lactate could be an important source of energy next to citrate when used as predilution (6, 7). During continuous venovenous hemofiltration (CVVH), a subgroup of CRRT which is performed with the newer dialysis fluids without lactate or glucose as advocated by the KDIGOguidelines, glucose and in a minor way lactate mostly induce a loss of energy. The first aim is to determine how this bioenergetic balance impacts energy need compared to the measured energy with indirect calorimetry and how nutrition therapy needs to be adapted.
Also, disease specific predicting equation have been created for patients suffering from acute kidney injury treated with renal replacement therapy. How this predicting equation and other existing predicting equations agree with the measured REE has not been validated yet. The second aim is to determine how predictive equations correlate with measured REE in patients treated with CVVH.
- Conditions
- Acute Kidney Injury, Continuous Venovenous Hemofiltration, Energy Metabolism, Resting Energy Expenditure, Nutrition Therapy
- Being tested
- bioenergetic balance
- 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.
bioenergetic balanceOther
Bioenergetic balance is calculated for all patients who had a resting energy expenditure measurement with indirect calorimetry.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | all patients Receives: Other: bioenergetic balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy
expressed in Kcal
Measured: during study completion, on average 4weeks
Secondary outcomes (2)
resting energy expenditure
expressed in Kcal
Measured: during study completion, on average 4weeks
protein to energy ratio
expressed in gr/Kcal
Measured: during study completion, on average 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Feb 2023
- Primary completion30 Apr 2023
- Study completion30 Sep 2024 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joop Jonckheer, PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483542
- Sponsor's protocol ID
- BUN 1432022000231
- Acronym
- BALANCE
- Status last verified
- Jun 2024
- First submitted
- 24 Jan 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If IPD is asked for, anonymized raw data can be shared
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of the Impact of Non-nutritional Calories During Continuous Veno-Venous Hemofiltration
- ClinicalTrials.gov ID
- NCT06483542
- Acronym / sponsor ID
- BALANCE / BUN 1432022000231
- Conditions
- Acute Kidney Injury, Continuous Venovenous Hemofiltration, Energy Metabolism, Resting Energy Expenditure, Nutrition Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 3 Jul 2024 (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 bioenergetic balance is the sum of energy exchanged during CRRT and is mostly defined by citrate glucose and lactate. When CRRT was performed with the older dialysis fluids, glucose and lactate could be an important source of energy next to citrate when used as predilution (6, 7). During continuous venovenous hemofiltration (CVVH), a subgroup of CRRT which is performed with the newer dialysis fluids without lactate or glucose as advocated by the KDIGOguidelines, glucose and in a minor way lactate mostly induce a loss of energy. The first aim is to determine how this bioenergetic balance impacts energy need compared to the measured energy with indirect calorimetry and how nutrition therapy needs to be adapted.
Also, disease specific predicting equation have been created for patients suffering from acute kidney injury treated with renal replacement therapy. How this predicting equation and other existing predicting equations agree with the measured REE has not been validated yet. The second aim is to determine how predictive equations correlate with measured REE in patients treated with CVVH.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: bioenergetic balanceall patients |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients with acute kidney injury who require CVVH
Key inclusion criteria (4 listed)
- Patients admitted to the adult ICU (01/01/2021-30/09/2022)
- At least one indirect calorimetry measurement (ventilator) or calculation based on harris benedict OR 25Kcal/kg/day
- Combined with bio energetic balance measurement
- Receiving CVVH during intensive care stay
Key exclusion criteria (4 listed)
- Patients admitted outside of the inclusion period will be excluded
- The absence of an indirect calorimetry measurement (ventilator) or calculation - based on the Harris Benedict OR 25Kcal/kg/day formula OR The absence of a bio energetic balance measurement
- The absence of CVVH during intensive care stay
- Pediatric (intensive care unit) patients
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 |
|---|---|---|
| bioenergetic balanceBioenergetic balance is calculated for all patients who had a resting energy expenditure measurement with indirect calorimetry. | Other | Group 1 |
Primary outcome
Energy
Time frame: during study completion, on average 4weeks
expressed in Kcal
2 secondary outcomes
resting energy expenditure
Time frame: during study completion, on average 4weeks
protein to energy ratio
Time frame: during study completion, on average 4weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Yes. If IPD is asked for, anonymized raw data can be shared
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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.
Joop Jonckheer, PhD principal investigator
Universitair Ziekenhuis Brussel
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 and Continuous Venovenous Hemofiltration, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 4 inclusion and 4 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 3 Jul 2024. 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 Belgium. 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?
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?
Energy (time frame: during study completion, on average 4weeks). 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 3 Jul 2024.