Acute Respiratory FailureNCT07909226
Lactate/Albumin Ratio and Mortality in Respiratory Failure
An observational study of Acute Respiratory Failure and Critical Illness, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This retrospective observational study aims to evaluate the association between the lactate-to-albumin ratio (LAR) measured at ICU admission and 28-day mortality in adult patients admitted to the intensive care unit with acute respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Critical Illness, Mortality
- What is being tested?
- Assessment of Admission Serum Lactate-to-Albumin Ratio (LAR)
- How many people
- 1,250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients (≥18 years) admitted for the first time to the intensive care unit of the Department of Anesthesiology and Reanimation, Kocaeli City Hospital, Turkey, with a diagnosis of acute respiratory failure between April 2023 and June 2026. Data will be retrospectively obtained from the hospital information system and patient records.
Who may be able to join
- Age 18 years or older
- First ICU admission with a diagnosis of acute respiratory failure between April 2023 and June 2026
Who cannot join
- Missing data in the hospital information system
- Known terminal-stage solid organ malignancy
- Laboratory data (lactate/albumin) obtained after albumin replacement
- ICU stay shorter than 24 hours
- Death within the first 24 hours of ICU admission
- Pregnancy
- Cardiopulmonary resuscitation within 24 hours before ICU admission
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kocaeli City Hospital
İzmit, Kocaeli, 41100
Ahmet Yüksek, Md, 05326580351, mdayuksek@hotmail.com
About this study
Official title: The Prognostic Role of the Lactate/Albumin Ratio in Predicting 28-Day Mortality in Patients Admitted to the Intensive Care Unit With a Diagnosis of Respiratory Failure
This retrospective observational study aims to evaluate the association between the lactate-to-albumin ratio (LAR) measured at ICU admission and 28-day mortality in adult patients admitted to the intensive care unit with acute respiratory failure. The study will also compare the prognostic value of LAR with that of existing clinical and laboratory parameters.
Read the detailed description
Acute respiratory failure is a common cause of intensive care unit (ICU) admission and is associated with high short-term mortality. Early risk stratification is important for guiding treatment intensity and resource allocation. Serum lactate reflects tissue hypoperfusion and impaired oxygen utilization, whereas serum albumin is a marker of nutritional status, systemic inflammation, and capillary leak. The lactate-to-albumin ratio (LAR) combines these two readily available laboratory parameters and has been proposed as a prognostic marker in critically ill patients. However, its prognostic value in patients with acute respiratory failure has not been well established.
This is a single-center, retrospective observational cohort study conducted at [center name], including adult patients (≥18 years) admitted to the ICU with acute respiratory failure between April 2023 and June-2026. Data will be obtained from the hospital information system and ICU records.
The primary objective is to evaluate the association between LAR at ICU admission and 28-day all-cause mortality. The secondary objective is to compare the prognostic performance of LAR with that of serum lactate alone, serum albumin alone, and established severity scores (e.g., APACHE II, SOFA).
The following data will be collected: demographic characteristics, comorbidities, cause of respiratory failure, need for invasive mechanical ventilation, severity scores, laboratory parameters (including lactate and albumin measured at ICU admission), ICU and hospital length of stay, and 28-day survival status. LAR will be calculated as serum lactate (mmol/L) divided by serum albumin (g/dL) .
Patients will be grouped as survivors and non-survivors at 28 days. The association between LAR and mortality will be assessed using logistic regression and/or Cox proportional hazards models adjusted for relevant confounders. Discriminative ability will be evaluated with receiver operating characteristic (ROC) curve analysis, and the optimal cut-off value will be determined. AUC values of LAR and the comparator parameters will be compared
- Being tested
- Assessment of Admission Serum Lactate-to-Albumin Ratio (LAR)
- Keywords
- Lactate-to-albumin ratio, LAR, ICU, Mortality, intensive care unit, respiratory failure
- Medical subject headings
- Critical Illness, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of Admission Serum Lactate-to-Albumin Ratio (LAR)Diagnostic test
In this observational cohort study, no experimental clinical intervention was administered. The primary exposure variable (prognostik marker/predictor) evaluated is the Lactate-to-Albumin Ratio (LAR), calculated from serum lactate level (mmol/L) divided by serum albumin level (g/dL) measured within the first 24 hours of intensive care unit admission.
| Study group | Role | What they receive |
|---|---|---|
| ICU patients with acute respiratory failure | Adult (≥18 years) patients admitted to the ICU with acute respiratory failure between April 2023 and June 2026, in whom lactate and albumin were measured at ICU admission. LAR will be calculated and its association with 28-day mortality will be evaluated. Receives: Diagnostic Test: Assessment of Admission Serum Lactate-to-Albumin Ratio (LAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic performance of LAR for 28-day mortality
Discriminative ability of LAR at ICU admission for predicting 28-day mortality, assessed by the area under the receiver operating characteristic curve (AUC), with determination of the optimal cut-off value.
Measured: 28 days after ICU admission
Secondary outcomes (1)
7-day mortality
Death from any cause within 7 days after ICU admission.
Measured: 7 days 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 posted2 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory 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
- Retrospective
- Enrolment
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmet Yuksek, Kocaeli City Hospital
- Investigators
- Ahmet Yüksek, Study director, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909226
- Sponsor's protocol ID
- 2026-174
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study data may be shared upon an appropriate request and institutional approval. It is not publicly available.
Publications
Tong H, Zhou W, Wu L, Zhu Q. Response to: Interpreting the prognostic value of the lactate-to-albumin ratio in severe acute pancreatitis. Saudi J Gastroenterol. 2026 Oct 13. doi: 10.4103/sjg.sjg_392_26. Online ahead of print. No abstract available.
PubMed 42873104C HP, Kumar PA. Lactate-albumin ratio as an early predictor of mortality in critically ill children: A prospective cohort study. Eur J Pediatr. 2026 Oct 16;185(11):854. doi: 10.1007/s00431-026-07525-x.
PubMed 42881277Arslan Aksu E, Ozdemir L, Gegin S, Ozdemir B. Prognostic value of systemic inflammatory markers in patients with malignancy-associated pulmonary thromboembolism: A retrospective observational study. Medicine (Baltimore). 2026 Oct 16;105(42):e51137. doi: 10.1097/MD.0000000000051137.
PubMed 42888546Mu Y, Tang H, Zeng Y, Wang Q, Huang T, Li W, Wu X, Pi S. LDAR shows more consistent prognostic performance than other albumin-derived indices for 28-day ICU mortality in critically ill patients with urosepsis: evidence from a dual-cohort retrospective study. Front Med (Lausanne). 2026 Oct 1;13:1915095. doi: 10.3389/fmed.2026.1915095. eCollection 2026.
PubMed 42889368Li G, Zhang D, Yuan F, Li M, Wang Y, Zhou J, Fu Y. Association of the lactate dehydrogenase-to-albumin ratio with all-cause and non-relapse mortality in patients with aGVHD after allogeneic HSCT: a single-center retrospective cohort study. Front Immunol. 2026 Oct 9;17:1936503. doi: 10.3389/fimmu.2026.1936503. eCollection 2026.
PubMed 42920470
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Role of the Lactate/Albumin Ratio in Predicting 28-Day Mortality in Patients Admitted to the Intensive Care Unit With a Diagnosis of Respiratory Failure
- ClinicalTrials.gov ID
- NCT07909226
- Acronym / sponsor ID
- 2026-174
- Keywords
- Lactate-to-albumin ratio, LAR, ICU, Mortality, intensive care unit, respiratory failure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 2 Nov 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.
This retrospective observational study aims to evaluate the association between the lactate-to-albumin ratio (LAR) measured at ICU admission and 28-day mortality in adult patients admitted to the intensive care unit with acute respiratory failure. The study will also compare the prognostic value of LAR with that of existing clinical and laboratory parameters.
Detailed description
Acute respiratory failure is a common cause of intensive care unit (ICU) admission and is associated with high short-term mortality. Early risk stratification is important for guiding treatment intensity and resource allocation. Serum lactate reflects tissue hypoperfusion and impaired oxygen utilization, whereas serum albumin is a marker of nutritional status, systemic inflammation, and capillary leak. The lactate-to-albumin ratio (LAR) combines these two readily available laboratory parameters and has been proposed as a prognostic marker in critically ill patients. However, its prognostic value in patients with acute respiratory failure has not been well established.
This is a single-center, retrospective observational cohort study conducted at [center name], including adult patients (≥18 years) admitted to the ICU with acute respiratory failure between April 2023 and June-2026. Data will be obtained from the hospital information system and ICU records.
The primary objective is to evaluate the association between LAR at ICU admission and 28-day all-cause mortality. The secondary objective is to compare the prognostic performance of LAR with that of serum lactate alone, serum albumin alone, and established severity scores (e.g., APACHE II, SOFA).
The following data will be collected: demographic characteristics, comorbidities, cause of respiratory failure, need for invasive mechanical ventilation, severity scores, laboratory parameters (including lactate and albumin measured at ICU admission), ICU and hospital length of stay, and 28-day survival status. LAR will be calculated as serum lactate (mmol/L) divided by serum albumin (g/dL) .
Patients will be grouped as survivors and non-survivors at 28 days. The association between LAR and mortality will be assessed using logistic regression and/or Cox proportional hazards models adjusted for relevant confounders. Discriminative ability will be evaluated with receiver operating characteristic (ROC) curve analysis, and the optimal cut-off value will be determined. AUC values of LAR and the comparator parameters will be compared
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients with acute respiratory failure | – | Diagnostic Test: Assessment of Admission Serum Lactate-to-Albumin Ratio (LAR)Adult (≥18 years) patients admitted to the ICU with acute respiratory failure between April 2023 and June 2026, in whom lactate and albumin were measured at ICU admission. LAR will be calculated and its association with 28-day mortality will be evaluated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) admitted for the first time to the intensive care unit of the Department of Anesthesiology and Reanimation, Kocaeli City Hospital, Turkey, with a diagnosis of acute respiratory failure between April 2023 and June 2026. Data will be retrospectively obtained from the hospital information system and patient records.
Key inclusion criteria (2 listed)
- Age 18 years or older
- First ICU admission with a diagnosis of acute respiratory failure between April 2023 and June 2026
Key exclusion criteria (7 listed)
- Missing data in the hospital information system
- Known terminal-stage solid organ malignancy
- Laboratory data (lactate/albumin) obtained after albumin replacement
- ICU stay shorter than 24 hours
- Death within the first 24 hours of ICU admission
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 |
|---|---|---|
| Assessment of Admission Serum Lactate-to-Albumin Ratio (LAR)In this observational cohort study, no experimental clinical intervention was administered. The primary exposure variable (prognostik marker/predictor) evaluated is the Lactate-to-Albumin Ratio (LAR), calculated from serum lactate level (mmol/L) divided by serum albumin level (g/dL) measured within the first 24 hours of intensive care unit admission. | Diagnostic test | ICU patients with acute respiratory failure |
Primary outcome
Prognostic performance of LAR for 28-day mortality
Time frame: 28 days after ICU admission
Discriminative ability of LAR at ICU admission for predicting 28-day mortality, assessed by the area under the receiver operating characteristic curve (AUC), with determination of the optimal cut-off value.
1 secondary outcome
7-day mortality
Time frame: 7 days after ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 42873104Tong H, Zhou W, Wu L, Zhu Q. Response to: Interpreting the prognostic value of the lactate-to-albumin ratio in severe acute pancreatitis. Saudi J Gastroenterol. 2026 Oct 13. doi: 10.4103/sjg.sjg_392_26. Online ahead of print. No abstract available.
- Background: PubMed 42881277C HP, Kumar PA. Lactate-albumin ratio as an early predictor of mortality in critically ill children: A prospective cohort study. Eur J Pediatr. 2026 Oct 16;185(11):854. doi: 10.1007/s00431-026-07525-x.
- Background: PubMed 42888546Arslan Aksu E, Ozdemir L, Gegin S, Ozdemir B. Prognostic value of systemic inflammatory markers in patients with malignancy-associated pulmonary thromboembolism: A retrospective observational study. Medicine (Baltimore). 2026 Oct 16;105(42):e51137. doi: 10.1097/MD.0000000000051137.
- Background: PubMed 42889368Mu Y, Tang H, Zeng Y, Wang Q, Huang T, Li W, Wu X, Pi S. LDAR shows more consistent prognostic performance than other albumin-derived indices for 28-day ICU mortality in critically ill patients with urosepsis: evidence from a dual-cohort retrospective study. Front Med (Lausanne). 2026 Oct 1;13:1915095. doi: 10.3389/fmed.2026.1915095. eCollection 2026.
- Background: PubMed 42920470Li G, Zhang D, Yuan F, Li M, Wang Y, Zhou J, Fu Y. Association of the lactate dehydrogenase-to-albumin ratio with all-cause and non-relapse mortality in patients with aGVHD after allogeneic HSCT: a single-center retrospective cohort study. Front Immunol. 2026 Oct 9;17:1936503. doi: 10.3389/fimmu.2026.1936503. eCollection 2026.
- Individual participant dataSharing planned: No. The study data may be shared upon an appropriate request and institutional approval. It is not publicly available.
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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.
Ahmet Yüksek study director
Kocaeli City Hospital
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 Respiratory Failure and Critical Illness, run by Kocaeli City Hospital 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 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: opening soon, as of the sponsor's last update on 2 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact aytuğ YILDIZ, MD (+905445306369, aytugyildiz9093@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic performance of LAR for 28-day mortality (time frame: 28 days 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 NCT07909226, which also lists 5 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 2 Nov 2026.