ICUPAB-TRACKNCT07414160
Association Between Dynamic Prealbumin Trajectories and Prognosis in Critically Ill Patients
An observational study of ICU and Critical Illness, run by The First Hospital of Jilin University.
Trial summary
Nutritional support therapy is a crucial part of ICU patient care, as both malnutrition and overnutrition can lead to adverse clinical outcomes. Meticulous monitoring of nutritional support is essential. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU, Critical Illness, Adult
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2026to 15 Apr 2027
- How long will I take part?
- 28 Days
- 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: Patients admitted to the ICU of Jilin University First Hospital.
Who may be able to join
- age > 18 years,
- SOFA score ≥ 2
- at least three prealbumin data points within the previous 14 days.
Who cannot join
- patients with liver failure
- patients with kidney failure,
- hereditary amyloidosis and Alzheimer's disease
- long-term use of hormones or NSAIDs. -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Association Between Dynamic Prealbumin Trajectories and Prognosis in Critically Ill Patients: A Prospective Observational Study
Nutritional support therapy is a crucial part of ICU patient care, as both malnutrition and overnutrition can lead to adverse clinical outcomes. Meticulous monitoring of nutritional support is essential. Unfortunately, to date, there are no biomarkers available to assess the appropriateness of nutritional support in the ICU setting. However, mounting evidence suggests that phenotypic analysis of patients using nutritional biomarkers or risk screening scores for adaptation may enhance our ability to characterize patients in terms of prognosis and likelihood of treatment response.
This study aims to identify the trajectory patterns of prealbumin changes based on dynamic monitoring data of prealbumin during hospitalization of critically ill patients, and to analyze the Association between different trajectory groups and patient prognosis. In addition, this study will further analyze its Association with nutritional intake and nutritional indicators, thereby assessing the potential value of prealbumin change trajectories in terms of the adequacy and effectiveness of nutritional support for critically ill patients.
Read the detailed description
Elevated prealbumin is a good predictor of positive nitrogen balance. Compared to albumin's half-life of 19-21 days, prealbumin is advantageous in assessing short-term nutritional changes and has been widely recognized as a biomarker for nutritional status and recovery of eating ability. However, prealbumin levels vary considerably depending on patient characteristics, degree of inflammation, and stage of critical illness. In acute inflammation, infection, or trauma, prealbumin concentrations decrease due to various factors, including cytokine-induced downregulation of synthesis, extravasation into the vascular system, blood dilution, and increased consumption. Multiple studies have shown that prealbumin is associated with poor prognosis.
Furthermore, the short half-life of prealbumin means that in the acute phase, PAB levels fluctuate over time. The trajectory of PAB level changes, rather than a single point, may provide a promising approach for dynamically assessing the adequacy and effectiveness of nutritional support in malnourished patients. This could help researchers more accurately describe and understand the heterogeneity and similarities within and between individual patients. Therefore, its dynamic changes may better reflect the severity of the patient's condition and the recovery of nutritional status. Previous studies have shown that for critically ill trauma patients, lower-than-normal total respiratory rate (TTR) levels upon admission are independently associated with poorer prognosis, while increased TTR levels over time are associated with better prognosis. Other studies have indicated that for every unit increase in CRP, TTR decreases by 0.024 units. This means that a 0.024-unit increase in CRP followed by a TTR decrease of more than 1 unit may be due to ineffective nutritional support. However, some researchers argue that prealbumin and the effectiveness of nutritional support are not related to outcome.
Therefore, changes in prealbumin levels in the early stages of critical illness pose a diagnostic challenge in distinguishing between the resolution of inflammation, the adequacy of nutritional support, and the shift towards anabolism.
This is an observational clinical study that will be conducted strictly in accordance with the STROBE guidelines. The first phase will utilize database analysis to track the dynamic trends of prealbumin levels, revealing the relationship between different trajectories and nutritional status and patient prognosis. The second phase will prospectively validate this study using similar patients treated at the Intensive Care Unit of Jilin University First Hospital, aiming to clarify the potential value of prealbumin in nutritional support and prognosis for critically ill patients.
- Conditions
- ICU, Critical Illness, Adult
- Being tested
- No Intervention: Observational Cohort
- Keywords
- prealbumin, Critically Ill Patients, Prognosis
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No study-specific intervention is assigned. Participants receive usual clinical care as determined by the treating team
| Study group | Role | What they receive |
|---|---|---|
| Critically ill adults admitted to the ICU | Age > 18 years, SOFA score ≥ 2, and at least three prealbumin data points within the previous 14 days. Exclusion criteria: patients with liver failure, kidney failure, hereditary amyloidosis and Alzheimer's disease, long-term use of hormones, or NSAIDs. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
Death from any cause occurring during the index ICU stay
Measured: From ICU admission (Day 1) through ICU discharge or death, whichever occurs first (up to 28 days).
Secondary outcomes (16)
In-hospital mortality
Death from any cause occurring during the index hospitalization.
Measured: From ICU admission (Day 1) through hospital discharge or death, whichever occurs first (up to 28 days).
ICU-acquired infection
New-onset infection occurring during the ICU stay (not present or incubating at ICU admission), diagnosed according to prespecified clinical and/or microbiological criteria.
Measured: From ICU admission (Day 1) through ICU discharge or death, whichever occurs first (up to 28 days).
ICU length of stay
Number of days from ICU admission to ICU discharge (or death in ICU), calculated in days.
Measured: From ICU admission (Day 1) through ICU discharge or death, whichever occurs first (up to 28 days).
Ventilator-free days through Day 28
Number of days alive and free from invasive mechanical ventilation from ICU admission through Day 28; patients who die before Day 28 are assigned 0 ventilator-free days.
Measured: 28 days after ICU admission
Vasopressor-free days during ICU stay
Vasopressor-free days, defined as the number of days alive and free of vasopressor therapy from ICU admission until ICU discharge; patients who die before ICU discharge are assigned 0 vasopressor-free days.
Measured: From ICU admission (Day 1) through ICU discharge or death, whichever occurs first (up to 28 days).
Survival time up to Day 28
Time from ICU admission to death from any cause; participants alive at Day 28 will be censored at Day 28
Measured: 28 days after ICU admission
Energy/Protein intake (weight-adjusted)
Average daily delivered energy /Protein normalized to body weight (kcal or g/kg/day) from enteral and parenteral nutrition (and other calorie sources if captured) over ICU Days 1-14.
Measured: Days 1-14 after ICU admission.
Longitudinal IL-6 levels during ICU Days 1-14
Interleukin-6 (IL-6) concentration was measured daily (or as clinically obtained) from ICU Day 1 through Day 14; longitudinal change will be evaluated using repeated-measures analysis across ICU Days 1-14.
Measured: During the first 14 days after ICU admission (ICU days 1-14).
Longitudinal change in albumin during ICU Days 1-14
Albumin was measured daily (or as clinically obtained) from ICU Day 1 through Day 14; longitudinal change will be evaluated using repeated-measures analysis across ICU Days 1-14.
Measured: During the first 14 days after ICU admission (ICU days 1-14).
Longitudinal change in CRP during ICU Days 1-14
CRP was measured daily (or as clinically obtained) from ICU Day 1 through Day 14; longitudinal change will be evaluated using repeated-measures analysis across ICU Days 1-14.
Measured: During the first 14 days after ICU admission (ICU days 1-14).
Longitudinal lymphocyte count during ICU Days 1-14
lymphocyte count was measured daily (or as clinically obtained) from ICU Day 1 through Day 14; longitudinal change will be evaluated using repeated-measures analysis across ICU Days 1-14.
Measured: During the first 14 days after ICU admission (ICU days 1-14).
Longitudinal change in White blood cell count during ICU Days 1-14
White blood cell count was measured daily (or as clinically obtained) from ICU Day 1 through Day 14; longitudinal change will be evaluated using repeated-measures analysis across ICU Days 1-14.
Measured: During the first 14 days after ICU admission (ICU days 1-14).
Longitudinal change in neutrophil count during ICU Days 1-14
Neutrophil count was measured daily (or as clinically obtained) from ICU Day 1 through Day 14; longitudinal change will be evaluated using repeated-measures analysis across ICU Days 1-14.
Measured: During the first 14 days after ICU admission (ICU days 1-14).
Creatinine longitudinal change in IL-6 during ICU Days 1-14
Creatinine was measured daily (or as clinically obtained) from ICU Day 1 through Day 14; longitudinal change will be evaluated using repeated-measures analysis across ICU Days 1-14.
Measured: During the first 14 days after ICU admission (ICU days 1-14).
Blood urea nitrogen Longitudinal change in IL-6 during ICU Days 1-14
Blood urea nitrogen was measured daily (or as clinically obtained) from ICU Day 1 through Day 14; longitudinal change will be evaluated using repeated-measures analysis across ICU Days 1-14.
Measured: During the first 14 days after ICU admission (ICU days 1-14).
BUN/prealbumin ratio
BUN/prealbumin ratio was measured daily (or as clinically obtained) from ICU Day 1 through Day 14; longitudinal change will be evaluated using repeated-measures analysis across ICU Days 1-14.
Measured: During the first 14 days after ICU admission (ICU days 1-14).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICUStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Zhang, The First Hospital of Jilin University
- Investigators
- dong zhang, Study chair, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414160
- Sponsor's protocol ID
- PAB-TRACK
- Acronym
- PAB-TRACK
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because the research data contains potentially identifiable information, there is still a risk of re-identification even after de-identification; and due to ethical approval, institutional data management policies, and limitations on the scope of informed consent from participants, IPD will not be shared publicly at this time. The research results will be published in summary statistical form.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Dynamic Prealbumin Trajectories and Prognosis in Critically Ill Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07414160
- Acronym / sponsor ID
- PAB-TRACK / PAB-TRACK
- Conditions
- ICU, Critical Illness, Adult
- Keywords
- prealbumin, Critically Ill Patients, Prognosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 17 Feb 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.
Nutritional support therapy is a crucial part of ICU patient care, as both malnutrition and overnutrition can lead to adverse clinical outcomes. Meticulous monitoring of nutritional support is essential. Unfortunately, to date, there are no biomarkers available to assess the appropriateness of nutritional support in the ICU setting. However, mounting evidence suggests that phenotypic analysis of patients using nutritional biomarkers or risk screening scores for adaptation may enhance our ability to characterize patients in terms of prognosis and likelihood of treatment response.
This study aims to identify the trajectory patterns of prealbumin changes based on dynamic monitoring data of prealbumin during hospitalization of critically ill patients, and to analyze the Association between different trajectory groups and patient prognosis. In addition, this study will further analyze its Association with nutritional intake and nutritional indicators, thereby assessing the potential value of prealbumin change trajectories in terms of the adequacy and effectiveness of nutritional support for critically ill patients.
Detailed description
Elevated prealbumin is a good predictor of positive nitrogen balance. Compared to albumin's half-life of 19-21 days, prealbumin is advantageous in assessing short-term nutritional changes and has been widely recognized as a biomarker for nutritional status and recovery of eating ability. However, prealbumin levels vary considerably depending on patient characteristics, degree of inflammation, and stage of critical illness. In acute inflammation, infection, or trauma, prealbumin concentrations decrease due to various factors, including cytokine-induced downregulation of synthesis, extravasation into the vascular system, blood dilution, and increased consumption. Multiple studies have shown that prealbumin is associated with poor prognosis.
Furthermore, the short half-life of prealbumin means that in the acute phase, PAB levels fluctuate over time. The trajectory of PAB level changes, rather than a single point, may provide a promising approach for dynamically assessing the adequacy and effectiveness of nutritional support in malnourished patients. This could help researchers more accurately describe and understand the heterogeneity and similarities within and between individual patients. Therefore, its dynamic changes may better reflect the severity of the patient's condition and the recovery of nutritional status. Previous studies have shown that for critically ill trauma patients, lower-than-normal total respiratory rate (TTR) levels upon admission are independently associated with poorer prognosis, while increased TTR levels over time are associated with better prognosis. Other studies have indicated that for every unit increase in CRP, TTR decreases by 0.024 units. This means that a 0.024-unit increase in CRP followed by a TTR decrease of more than 1 unit may be due to ineffective nutritional support. However, some researchers argue that prealbumin and the effectiveness of nutritional support are not related to outcome.
Therefore, changes in prealbumin levels in the early stages of critical illness pose a diagnostic challenge in distinguishing between the resolution of inflammation, the adequacy of nutritional support, and the shift towards anabolism.
This is an observational clinical study that will be conducted strictly in accordance with the STROBE guidelines. The first phase will utilize database analysis to track the dynamic trends of prealbumin levels, revealing the relationship between different trajectories and nutritional status and patient prognosis. The second phase will prospectively validate this study using similar patients treated at the Intensive Care Unit of Jilin University First Hospital, aiming to clarify the potential value of prealbumin in nutritional support and prognosis for critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill adults admitted to the ICU | – | Other: No Intervention: Observational CohortAge > 18 years, SOFA score ≥ 2, and at least three prealbumin data points within the previous 14 days. Exclusion criteria: patients with liver failure, kidney failure, hereditary amyloidosis and Alzheimer's disease, long-term use of hormones, or NSAIDs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU of Jilin University First Hospital.
Key inclusion criteria (3 listed)
- age > 18 years,
- SOFA score ≥ 2
- at least three prealbumin data points within the previous 14 days.
Key exclusion criteria (4 listed)
- patients with liver failure
- patients with kidney failure,
- hereditary amyloidosis and Alzheimer's disease
- long-term use of hormones or NSAIDs. -
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 |
|---|---|---|
| No Intervention: Observational CohortNo study-specific intervention is assigned. Participants receive usual clinical care as determined by the treating team | Other | Critically ill adults admitted to the ICU |
Primary outcome
ICU mortality
Time frame: From ICU admission (Day 1) through ICU discharge or death, whichever occurs first (up to 28 days).
Death from any cause occurring during the index ICU stay
16 secondary outcomes
In-hospital mortality
Time frame: From ICU admission (Day 1) through hospital discharge or death, whichever occurs first (up to 28 days).
ICU-acquired infection
Time frame: From ICU admission (Day 1) through ICU discharge or death, whichever occurs first (up to 28 days).
ICU length of stay
Time frame: From ICU admission (Day 1) through ICU discharge or death, whichever occurs first (up to 28 days).
Ventilator-free days through Day 28
Time frame: 28 days after ICU admission
Vasopressor-free days during ICU stay
Time frame: From ICU admission (Day 1) through ICU discharge or death, whichever occurs first (up to 28 days).
Survival time up to Day 28
Time frame: 28 days after ICU admission
Energy/Protein intake (weight-adjusted)
Time frame: Days 1-14 after ICU admission.
Longitudinal IL-6 levels during ICU Days 1-14
Time frame: During the first 14 days after ICU admission (ICU days 1-14).
Longitudinal change in albumin during ICU Days 1-14
Time frame: During the first 14 days after ICU admission (ICU days 1-14).
Longitudinal change in CRP during ICU Days 1-14
Time frame: During the first 14 days after ICU admission (ICU days 1-14).
Longitudinal lymphocyte count during ICU Days 1-14
Time frame: During the first 14 days after ICU admission (ICU days 1-14).
Longitudinal change in White blood cell count during ICU Days 1-14
Time frame: During the first 14 days after ICU admission (ICU days 1-14).
Longitudinal change in neutrophil count during ICU Days 1-14
Time frame: During the first 14 days after ICU admission (ICU days 1-14).
Creatinine longitudinal change in IL-6 during ICU Days 1-14
Time frame: During the first 14 days after ICU admission (ICU days 1-14).
Blood urea nitrogen Longitudinal change in IL-6 during ICU Days 1-14
Time frame: During the first 14 days after ICU admission (ICU days 1-14).
BUN/prealbumin ratio
Time frame: During the first 14 days after ICU admission (ICU days 1-14).
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 17 Feb 2026.
- Individual participant dataSharing planned: No. Because the research data contains potentially identifiable information, there is still a risk of re-identification even after de-identification; and due to ethical approval, institutional data management policies, and limitations on the scope of informed consent from participants, IPD will not be shared publicly at this time. The research results will be published in summary statistical form.
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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.
dong zhang study chair
The First Hospital of Jilin University
Questions about this trial
What is this clinical trial studying?
An observational study of ICU and Critical Illness, run by The First Hospital of Jilin University.
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 3 inclusion and 4 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 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Yanhua Li (15804301738, liyanhua@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU mortality (time frame: From ICU admission (Day 1) through ICU discharge or death, whichever occurs first (up to 28 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2026.