Acute Renal FailureIRATICNCT04599569
Influence of Renal Replacement TherApy on Indirect Calorimetry
An observational study of Acute Renal Failure and Mechanical Ventilation, run by University of Leipzig at 1 site in Germany.
Trial summary
Renal replacement therapy may affect carbon dioxide elimination, which may theoretically influence measurement of energy expenditure by means of indirect calorimetry. However, available clinical studies are noct conclusive on this issue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure, Mechanical Ventilation
- What is being tested?
- indirect calorimetry
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 20 Oct 2020to 30 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: critically ill mechanically ventilated medical patients requiring renal replacement therapy
Who may be able to join
- simultaneous requirement for mechanical ventilation and renal replacement therapy
- informed consent
Who cannot join
- age <18 years
- requirement for therapeutic hypothermia
- serum lactate >4 mmol/l
- requirement for inspiratory oxygen fraction >0.6 and positive end-expiratory pressure >12 mbar
- leak in the ventilator circuit (e.g. due to a chest tube)
- requirement for extracorporeal circulatory support
- refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Renal Replacement TherApy on Indirect Calorimetry: a Prospective Observational Study
Renal replacement therapy may affect carbon dioxide elimination, which may theoretically influence measurement of energy expenditure by means of indirect calorimetry. However, available clinical studies are noct conclusive on this issue. This observational study aims to investigate the effect of renal replacement therapy on indirect calorimetry in critically ill mechanically ventilated patients.
Read the detailed description
Optimal Nutrition of the critically ill is still a clinical challenge. Current guidelines recommend that measurement of energy expenditure using indirect calorimetry should be favoured in critically ill patients. The technique is based on measurement of oxygen consumption and carbon dioxide elimination. Experimental studies have reported on carbon dioxide elimination via renal replacement therapy. Since acute kidney injury with requirement for renal replacement therapy (RRT) is common in the intensive care unit, the significance of carbon dioxide elimination via the dialyser should be clarified. However, available evidence from clinical studies is contradictory, one reason being the heterogenous study design.
In this prospective observational study on critically ill mechanically ventilated medical patients requiring RRT, indirect calorimetry (IC) will be conducted twice on the same day with and without RRT: either immediately before commencement of RRT followed by a second IC with RRT after an RRT run time of an hour, or immediately before the end of an RRT session followed by a second IC an hour after the termination of RRT.
- Conditions
- Acute Renal Failure, Mechanical Ventilation
- Being tested
- indirect calorimetry
- Keywords
- indirect calorimetry, energy expenditure, carbon dioxide elimination, renal replacement therapy, respiratory quotient
- 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.
indirect calorimetryDevice
indirect calorimetry with and without renal replacement therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
energy expenditure
energy expenditure in kcal/d
Measured: 60 minutes
Secondary outcomes (2)
Carbon dioxide elimination
Carbon dioxide elimination in ml/min
Measured: 60 minutes
respiratory quotient
respiratory Quotient, defined as the Ratio of Carbon dioxide elimination to Oxygen consumption
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start20 Oct 2020
- Primary completion31 May 2024
- Study completion30 Jun 2024
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 Renal FailureStudies 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sirak Petros, MD, University of Leipzig
- Investigators
- Sirak Petros, MD, Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599569
- Sponsor's protocol ID
- IRATIC-2020
- Acronym
- IRATIC
- Status last verified
- Dec 2024
- First submitted
- 18 Oct 2020
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Knoll A, Petros S, Pasieka B, Weidhase L. Influence of kidney replacement therapy on indirect calorimetry in critically ill patients. Eur J Clin Nutr. 2025 Nov;79(11):1144-1148. doi: 10.1038/s41430-025-01643-9. Epub 2025 Jul 30.
PubMed 40739037
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Renal Replacement TherApy on Indirect Calorimetry: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04599569
- Acronym / sponsor ID
- IRATIC / IRATIC-2020
- Conditions
- Acute Renal Failure, Mechanical Ventilation
- Keywords
- indirect calorimetry, energy expenditure, carbon dioxide elimination, renal replacement therapy, respiratory quotient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 22 Oct 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.
Renal replacement therapy may affect carbon dioxide elimination, which may theoretically influence measurement of energy expenditure by means of indirect calorimetry. However, available clinical studies are noct conclusive on this issue. This observational study aims to investigate the effect of renal replacement therapy on indirect calorimetry in critically ill mechanically ventilated patients.
Detailed description
Optimal Nutrition of the critically ill is still a clinical challenge. Current guidelines recommend that measurement of energy expenditure using indirect calorimetry should be favoured in critically ill patients. The technique is based on measurement of oxygen consumption and carbon dioxide elimination. Experimental studies have reported on carbon dioxide elimination via renal replacement therapy. Since acute kidney injury with requirement for renal replacement therapy (RRT) is common in the intensive care unit, the significance of carbon dioxide elimination via the dialyser should be clarified. However, available evidence from clinical studies is contradictory, one reason being the heterogenous study design.
In this prospective observational study on critically ill mechanically ventilated medical patients requiring RRT, indirect calorimetry (IC) will be conducted twice on the same day with and without RRT: either immediately before commencement of RRT followed by a second IC with RRT after an RRT run time of an hour, or immediately before the end of an RRT session followed by a second IC an hour after the termination of RRT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically ill mechanically ventilated medical patients requiring renal replacement therapy
Key inclusion criteria (2 listed)
- simultaneous requirement for mechanical ventilation and renal replacement therapy
- informed consent
Key exclusion criteria (7 listed)
- age <18 years
- requirement for therapeutic hypothermia
- serum lactate >4 mmol/l
- requirement for inspiratory oxygen fraction >0.6 and positive end-expiratory pressure >12 mbar
- leak in the ventilator circuit (e.g. due to a chest tube)
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 |
|---|---|---|
| indirect calorimetryindirect calorimetry with and without renal replacement therapy | Device | – |
Primary outcome
energy expenditure
Time frame: 60 minutes
energy expenditure in kcal/d
2 secondary outcomes
Carbon dioxide elimination
Time frame: 60 minutes
respiratory quotient
Time frame: 60 minutes
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 20 Dec 2024.
- Derived from this study: PubMed 40739037Knoll A, Petros S, Pasieka B, Weidhase L. Influence of kidney replacement therapy on indirect calorimetry in critically ill patients. Eur J Clin Nutr. 2025 Nov;79(11):1144-1148. doi: 10.1038/s41430-025-01643-9. Epub 2025 Jul 30.
- Individual participant dataSharing planned: Undecided
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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.
Sirak Petros, MD principal investigator
University of Leipzig
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 Renal Failure and Mechanical Ventilation, run by University of Leipzig at 1 site in Germany.
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 2 inclusion and 7 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 20 Dec 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 Germany. 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?
energy expenditure (time frame: 60 minutes). 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 NCT04599569, 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 20 Dec 2024.