Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 7:19 AM
Study NCT ID:
NCT07414160
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Dynamic Prealbumin Trajectories and Prognosis in Critically Ill Patients
Sponsor:
The First Hospital of Jilin University
Organization:
Study Overview
Official Title:
Association Between Dynamic Prealbumin Trajectories and Prognosis in Critically Ill Patients: A Prospective Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAB-TRACK
Brief 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. 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: