- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07761832
Hemoglobin Trends as a Predictor of Outcomes in Critically Ill Patients (The TRENT-ICU Study)
The TRENT-ICU Study (Transfusion Threshold Based on Hemoglobin Trends): Hemoglobin Drop Rate as a Predictor of Adverse Clinical Outcomes in Critically Ill Patients
The goal of this observational study is to evaluate if early absolute hemoglobin decline (during the first 24 hours of admission) can predict prolonged intensive care unit stay (8 days or more) and in-hospital mortality in critically ill adult patients.
The main questions it aims to answer are:
Does absolute hemoglobin decline during the first 24 hours of admission independently predict prolonged intensive care unit stay in critically ill adult patients?
Does absolute hemoglobin decline during the first 24 hours of admission independently predict in-hospital mortality in critically ill adult patients?
Participants will:
Have their routine clinical and laboratory data reviewed retrospectively from their electronic health records (including baseline hemoglobin and a second hemoglobin determination approximately 24 hours after admission). No additional interventions or extra blood draws will be performed beyond routine clinical care.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Querétaro
-
Querétaro City, Querétaro, Mexico, 76000
- Hospital H+ Querétaro, Santiago de Querétaro, Querétaro
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients (aged 18 years or older) admitted to the Intensive Care Unit (ICU) between January 2024 and January 2026.
- ICU length of stay greater than 48 hours.
- At least two hemoglobin determinations obtained with an interval of approximately 24 hours apart during routine medical care.
Exclusion Criteria:
- Massive bleeding upon ICU admission.
- Massive transfusion protocol activation.
- Pregnancy.
- Hemoglobinopathies.
- Active hemolytic anemia.
- Medical records with insufficient information for analysis.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Critically Ill Adult Patients
Adult patients admitted to the intensive care unit with an ICU stay of more than 48 hours and at least two hemoglobin determinations obtained approximately 24 hours apart during routine care.
|
Measurement of the absolute difference in hemoglobin concentration (g/dL) between baseline ICU admission and approximately 24 hours post-admission.
Data was collected retrospectively from electronic health records.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prolonged Intensive Care Unit Stay
Time Frame: From ICU admission up to 28 days
|
Incidence of prolonged intensive care unit (ICU) length of stay, defined a priori as an ICU stay equal to or greater than 8 days.
|
From ICU admission up to 28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
In-Hospital Mortality
Time Frame: From ICU admission up to 30 days
|
Incidence of all-cause mortality recorded at hospital discharge.
|
From ICU admission up to 30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEI2026-30/04/V1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.