Acute Kidney InjuryNCT07654010
The Value of Partial Arterial Carbon Dioxide Pressure - End-Tidal Carbon Dioxide Gradient Courses in Predicting Acute Renal Injury in Critically Ill Patients on Mechanical Ventilation: A Novel Hemodynamic Marker?
An observational study of Acute Kidney Injury and Ventilated Patient in Intensive Care, run by Malatya Egitim Ve Arastirma Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
End-tidal carbon dioxide (EtCO₂) refers to the level of carbon dioxide in the air exhaled during expiration and is measured using capnography. EtCO₂ is an important monitoring parameter in the management of critically ill patients on mechanical ventilation, providing indirect information about the patient's cardiac… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Ventilated Patient in Intensive Care
- How many people
- 155 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2026to 5 Jun 2026
- How long will I take part?
- 30 Days
- 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 being monitored with mechanical ventilators in intensive care
Who may be able to join
- Patients over 18 years of age
- patients under mechanical ventilation
- initiation of EtCO₂ monitoring within the first hour of admission to the ICU
- patients monitored in the ICU for at least 24 hours
- having undergone arterial blood gas analysis (for PaCO₂ measurement) within the first 24 hours.
Who cannot join
- Patients under 18 years of age
- intensive care unit monitoring shorter than 24 hours
- missing or inaccessible clinical data
- chronic renal failure
- acute renal failure present at admission to intensive care unit
- advanced pulmonary diseases affecting EtCO₂ measurement (e.g., severe obstruction, giant bulla, advanced emphysema)
- patients in whom PaCO₂ measurement cannot be performed
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Malatya Training and Research Hospital
Malatya, Osmaniye, +90(505)620-3888
About this study
End-tidal carbon dioxide (EtCO₂) refers to the level of carbon dioxide in the air exhaled during expiration and is measured using capnography. EtCO₂ is an important monitoring parameter in the management of critically ill patients on mechanical ventilation, providing indirect information about the patient's cardiac output, pulmonary perfusion-ventilation (V/Q) status, and metabolic activity. The Pa-EtCO₂ gradient, the difference between EtCO₂ and arterial CO₂ partial pressure (PaCO₂), changes significantly, especially in cases of hemodynamic deterioration, microcirculatory failure, and increased dead space. Therefore, the gradient is considered a potential indicator of perfusion in critically ill patients. In critically ill patients on mechanical ventilation, the usability of changes (courses) of the Pa-EtCO₂ gradient over time is being evaluated not only as an indicator of ventilation but also as a dynamic and indirect predictor of hemodynamic status and renal perfusion. Therefore, it should be investigated whether the Pa-EtCO2 gradient is a suitable parameter for early detection of AKI (acute kidney injury) development in patients with renal perfusion impairment.
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in PaCO₂-EtCO₂ Gradient at 6, 12, and 24 Hours After ICU Admission
The PaCO₂-EtCO₂ gradient will be calculated as arterial carbon dioxide pressure minus end-tidal carbon dioxide pressure at baseline and at 6, 12, and 24 hours after ICU admission. Change from baseline will be reported for each follow-up time point in mmHg.
Measured: Baseline, 6 hours, 12 hours, and 24 hours after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start15 Mar 2026
- Primary completion15 May 2026
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 155 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Malatya Egitim Ve Arastirma Hastanesi
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Leman Acun Delen, Malatya Egitim Ve Arastirma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654010
- Sponsor's protocol ID
- MEAH-AKI-ICU-2026-01
- Status last verified
- Jan 2026
- First submitted
- 9 Apr 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Defilippis V, D'Antini D, Cinnella G, Dambrosio M, Schiraldi F, Procacci V. End-tidal arterial CO2 partial pressure gradient in patients with severe hypercapnia undergoing noninvasive ventilation. Open Access Emerg Med. 2013 Jun 19;5:1-7. doi: 10.2147/OAEM.S43070. eCollection 2013.
PubMed 27147867Belenkiy SM, Berry JS, Batchinsky AI, Kendrick C, Necsoiu C, Jordan BS, Salinas J, Cancio LC. The noninvasive carbon dioxide gradient (NICO2G) during hemorrhagic shock. Shock. 2014 Jul;42(1):38-43. doi: 10.1097/SHK.0000000000000177.
PubMed 24667626Inan G, Kara Cetsmall i, Ukrainiannbsmall i, Ukrainianlek PH, Gonullu H. Comparison of End-Tidal Carbon Dioxide (ETCO2) Gradient and Vena Cava Collapsibility Index (VCCI) in Response to Intravenous Fluid Therapy in Patients with Moderate and Severe Dehydration and Acute Gastroenteritis. Prehosp Disaster Med. 2022 Aug;37(4):474-479. doi: 10.1017/S1049023X22000838. Epub 2022 May 25.
PubMed 35611835
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Partial Arterial Carbon Dioxide Pressure - End-Tidal Carbon Dioxide Gradient Courses in Predicting Acute Renal Injury in Critically Ill Patients on Mechanical Ventilation: A Novel Hemodynamic Marker?
- ClinicalTrials.gov ID
- NCT07654010
- Acronym / sponsor ID
- MEAH-AKI-ICU-2026-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Malatya Egitim Ve Arastirma HastanesiOther government
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 17 Jun 2026 (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.
End-tidal carbon dioxide (EtCO₂) refers to the level of carbon dioxide in the air exhaled during expiration and is measured using capnography. EtCO₂ is an important monitoring parameter in the management of critically ill patients on mechanical ventilation, providing indirect information about the patient's cardiac output, pulmonary perfusion-ventilation (V/Q) status, and metabolic activity. The Pa-EtCO₂ gradient, the difference between EtCO₂ and arterial CO₂ partial pressure (PaCO₂), changes significantly, especially in cases of hemodynamic deterioration, microcirculatory failure, and increased dead space. Therefore, the gradient is considered a potential indicator of perfusion in critically ill patients. In critically ill patients on mechanical ventilation, the usability of changes (courses) of the Pa-EtCO₂ gradient over time is being evaluated not only as an indicator of ventilation but also as a dynamic and indirect predictor of hemodynamic status and renal perfusion. Therefore, it should be investigated whether the Pa-EtCO2 gradient is a suitable parameter for early detection of AKI (acute kidney injury) development in patients with renal perfusion impairment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients being monitored with mechanical ventilators in intensive care
Key inclusion criteria (5 listed)
- Patients over 18 years of age
- patients under mechanical ventilation
- initiation of EtCO₂ monitoring within the first hour of admission to the ICU
- patients monitored in the ICU for at least 24 hours
- having undergone arterial blood gas analysis (for PaCO₂ measurement) within the first 24 hours.
Key exclusion criteria (7 listed)
- Patients under 18 years of age
- intensive care unit monitoring shorter than 24 hours
- missing or inaccessible clinical data
- chronic renal failure
- acute renal failure present at admission to intensive care unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change From Baseline in PaCO₂-EtCO₂ Gradient at 6, 12, and 24 Hours After ICU Admission
Time frame: Baseline, 6 hours, 12 hours, and 24 hours after ICU admission
The PaCO₂-EtCO₂ gradient will be calculated as arterial carbon dioxide pressure minus end-tidal carbon dioxide pressure at baseline and at 6, 12, and 24 hours after ICU admission. Change from baseline will be reported for each follow-up time point in mmHg.
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 17 Jun 2026.
- Results publication: PubMed 27147867Defilippis V, D'Antini D, Cinnella G, Dambrosio M, Schiraldi F, Procacci V. End-tidal arterial CO2 partial pressure gradient in patients with severe hypercapnia undergoing noninvasive ventilation. Open Access Emerg Med. 2013 Jun 19;5:1-7. doi: 10.2147/OAEM.S43070. eCollection 2013.
- Results publication: PubMed 24667626Belenkiy SM, Berry JS, Batchinsky AI, Kendrick C, Necsoiu C, Jordan BS, Salinas J, Cancio LC. The noninvasive carbon dioxide gradient (NICO2G) during hemorrhagic shock. Shock. 2014 Jul;42(1):38-43. doi: 10.1097/SHK.0000000000000177.
- Results publication: PubMed 35611835Inan G, Kara Cetsmall i, Ukrainiannbsmall i, Ukrainianlek PH, Gonullu H. Comparison of End-Tidal Carbon Dioxide (ETCO2) Gradient and Vena Cava Collapsibility Index (VCCI) in Response to Intravenous Fluid Therapy in Patients with Moderate and Severe Dehydration and Acute Gastroenteritis. Prehosp Disaster Med. 2022 Aug;37(4):474-479. doi: 10.1017/S1049023X22000838. Epub 2022 May 25.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ventilated Patient in Intensive Care, run by Malatya Egitim Ve Arastirma Hastanesi at 1 site in Turkey (Türkiye).
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 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 17 Jun 2026. 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 Turkey (Türkiye). 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?
Change From Baseline in PaCO₂-EtCO₂ Gradient at 6, 12, and 24 Hours After ICU Admission (time frame: Baseline, 6 hours, 12 hours, and 24 hours after ICU admission). 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 NCT07654010, which also lists 3 linked publications.
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 17 Jun 2026.