Lactate/Albumin Ratio and Mortality in Respiratory Failure

November 9, 2026 updated by: Ahmet Yuksek, Kocaeli City Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Kocaeli City Hospital, 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Age 18 years or older
  • First ICU admission with a diagnosis of acute respiratory failure between April 2023 and June 2026

Exclusion Criteria:

  • 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

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

  • Observational Models: COHORT
  • Time Perspectives: RETROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Diagnostic test: Assessment of Admission Serum Lactate-to-Albumin Ratio (LAR)

In this observational cohort study, no experimental clinical intervention was administered. The primary exposure variable (prognostic 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
28 days after ICU admission

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
7-day mortality
Time Frame: 7 days after ICU admission

Death from any cause within 7 days after ICU admission.
7 days after ICU admission

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of LAR with serum lactate and serum albumin alone
Time Frame: 28 days after ICU admission

Comparison of the predictive performance (AUC) of LAR with that of lactate alone and albumin alone for 28-day mortality.
28 days after ICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kocaeli City Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ahmet Yüksek, MD, Kocaeli City Hospital
  • Principal Investigator: Aytuğ Yıldız, MD, Kocaeli City Hospital

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study data may be shared upon an appropriate request and institutional approval. It is not publicly available.

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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