- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07654010
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?
June 13, 2026 updated by: Leman Acun Delen, Malatya Egitim Ve Arastirma Hastanesi
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 Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
155
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Osmaniye
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Malatya, Osmaniye, Turkey (Türkiye), +90(505)620-3888
- Malatya Training and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patients being monitored with mechanical ventilators in intensive care
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 6 hours, 12 hours, and 24 hours after ICU admission
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Belenkiy 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.
- Inan 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2026
Primary Completion (Actual)
May 15, 2026
Study Completion (Actual)
June 5, 2026
Study Registration Dates
First Submitted
April 9, 2026
First Submitted That Met QC Criteria
June 13, 2026
First Posted (Actual)
June 17, 2026
Study Record Updates
Last Update Posted (Actual)
June 17, 2026
Last Update Submitted That Met QC Criteria
June 13, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEAH-AKI-ICU-2026-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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