Measurement of Mass Change in Serum Albumin Compared to Serum Lactic Acid as Predictive Tool for Sepsis Prognosis in Non Surgical ICU Patients

December 5, 2025 updated by: Ain Shams University
This study aims to assess the reliability of measurement of mass change in serum albumin compared to serum lactic acid as predictive tool for sepsis prognosis in nonsurgical ICU patients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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

This study explores the prognostic value of mass change in serum albumin compared to serum lactic acid levels in non-surgical ICU patients with sepsis. While serum lactate is an established marker of tissue hypo-perfusion and a predictor of sepsis outcomes, serum albumin is less frequently used for dynamic monitoring, although it is known to correlate with severity and mortality

Measurements:

Data Collection:

A-Baseline Data on ICU Admission:

  1. Demographics: age, sex
  2. Comorbidities (e.g., diabetes, hypertension, chronic kidney disease)
  3. Initial hemodynamic parameters (BP-HR-SO2-ECG-UOP-TEMP-RR)

  4. diagnosis of sepsis involves recognising signs of infection plus organ dysfunction according to SSC and sepsis -3

    A- Search about source of infection by:

    • History of present illness about main complain.
    • clinical examination
    • investigation a. labs (CBC (containing TLC and platlets), CRP, Procal, BloodGases (containing serum lactate), Urea, serum Creatinine, TotaL bilirubin, Urine Analysis, Pan culture, AST, ALT) b-imaging (chest x.ray) B- organ dysfunction Defined as increase increase in SOFA (Sequential Organ Failure Assessment) score >=2 points from baseline.

    SOFA Score range:

    0-6: low risk of organ failure 7-12: moderate risk >12: high risk of mortality

  5. initial reading of serum albumin in admission (T0)
  6. initial reading of albumin creat ratio (ACR)as tool for measuring albumin in urine Patients with severe albuminuria will be excluded from the study

Daily measurements:

  1. Average of 24 HR (BP, HR, SO2, TEMP, RR,)
  2. CBC, CRP, serum urea, serum creatinine, Total bilirubin, serum Albumin, blood gases (containing serum lactate)

3-24HR Fluid balance.

  • ACR will be measured every 3days during study to predict any abnormal increase in albumin loss in urine

C- Daily recordings:

  1. SOFA score.
  2. mass changes in serum albumin (T0-T1, T1-T2, T3-T2……...ETC).
  3. serum lactate.
  4. vasopressor use.

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 (Actual)

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.
40

Contacts and Locations

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

Study Locations

  • Egypt
    • Elabasya
      • Cairo, Elabasya, Egypt
        • Hospitals ofAin shams university

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

A prospective cohort study is planned, aiming to enroll a minimum of 40 patients. The sample size calculation is based on findings from Mahashabde et al. (2024), which reported that the predictive accuracy of serum lactase for septic shock at admission had an AUC ROC of 0.96, while serum albumin had an AUC ROC of 0.323. The anticipated incidence of septic shock is 42%, as reported in the EPIC ill study (2019). The sample size was calculated to achieve 100% statistical power with a significance level (alpha) of 0.05.

Description

Inclusion Criteria:

  • Adults aged ≥18 year 70 years. Diagnosis of sepsis according to survival sepsis campaign(SSC). Patients admitted for medical (non-surgical) conditions.

Exclusion Criteria:

  • Chronic liver disease or cirrhosis. Hyperalbuminuria (ex: nephrotic syndrome, nephritic syndrome). Terminal illness with an expected survival of less than 24 hours. Refusal or inability to obtain informed consent from patients or their care givers.

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

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
Comparative value between mass change in serum albumin and serum lactate in prediction of sepsis prognosis (discharge or mortality)
Time Frame: 12 months
Knowing Which is more accurate in predicting the prognosis of sepsis between mass change in serum albumin and serum lactic acid in non surgical icu patients
12 months

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
Duration of vasopressor use and its correlation to prognosis of sepsis.
Time Frame: 12months
If long duration of using vasopressor correlate with prognosis of sepsis
12months

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.
Ain Shams University

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: Alaa E Mohamed Hassen, Prof, Department of anesthesia ,Intensive Care and pain management

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.
September 28, 2025

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.
September 28, 2026

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.
September 28, 2026

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).
December 5, 2025

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.
December 5, 2025

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.
December 17, 2025

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.
December 17, 2025

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.
December 5, 2025

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, 2025

More Information

Terms related to this study

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.
  • MD241/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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